Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00095238
Registration number
NCT00095238
Ethics application status
Date submitted
1/11/2004
Date registered
2/11/2004
Date last updated
7/04/2015
Titles & IDs
Public title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Query!
Scientific title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Query!
Secondary ID [1]
0
0
CV131-148
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Congestive Heart Failure
0
0
Query!
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Coronary heart disease
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Irbesartan
Treatment: Drugs - Placebo
Active comparator: 1 -
Placebo comparator: 2 -
Treatment: Drugs: Irbesartan
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
Treatment: Drugs: Placebo
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
Query!
Assessment method [1]
0
0
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those =24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.
Query!
Timepoint [1]
0
0
Year 1, Year 2, Year 3, Year 4, Year 5
Query!
Secondary outcome [1]
0
0
Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
Query!
Assessment method [1]
0
0
Treatment comparisons for time to heart failure mortality or heart failure hospitalization
Query!
Timepoint [1]
0
0
Year 1, Year 2, Year 3, Year 4, Year 5
Query!
Secondary outcome [2]
0
0
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
Query!
Assessment method [2]
0
0
Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Query!
Timepoint [2]
0
0
Baseline, Month 6, Month 14
Query!
Secondary outcome [3]
0
0
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
Query!
Assessment method [3]
0
0
Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Query!
Timepoint [3]
0
0
Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Query!
Secondary outcome [4]
0
0
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
Query!
Assessment method [4]
0
0
Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.
Query!
Timepoint [4]
0
0
Baseline, Month 6, Month 14
Query!
Secondary outcome [5]
0
0
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
Query!
Assessment method [5]
0
0
Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.
Query!
Timepoint [5]
0
0
Year 1, Year 2, Year 3, Year 4, Year 5
Query!
Secondary outcome [6]
0
0
Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
Query!
Assessment method [6]
0
0
Treatment comparisons for time to cardiovascular death
Query!
Timepoint [6]
0
0
Year 1, Year 2, Year 3, Year 4, Year 5
Query!
Secondary outcome [7]
0
0
Percentage of Participants Experiencing All-cause Death at Given Time Points
Query!
Assessment method [7]
0
0
Treatment comparisons for time to all-cause death
Query!
Timepoint [7]
0
0
Year 1, Year 2, Year 3, Year 4, Year 5
Query!
Secondary outcome [8]
0
0
Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
Query!
Assessment method [8]
0
0
NYHA functional classification=4-tiered system relating symptoms to everyday activities \& quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form \[CRF\] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.
Query!
Timepoint [8]
0
0
Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Query!
Secondary outcome [9]
0
0
Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Query!
Assessment method [9]
0
0
This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Query!
Timepoint [9]
0
0
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Query!
Secondary outcome [10]
0
0
Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Query!
Assessment method [10]
0
0
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Query!
Timepoint [10]
0
0
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Query!
Secondary outcome [11]
0
0
Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
Query!
Assessment method [11]
0
0
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Query!
Timepoint [11]
0
0
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Query!
Secondary outcome [12]
0
0
Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
Query!
Assessment method [12]
0
0
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Query!
Timepoint [12]
0
0
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Query!
Secondary outcome [13]
0
0
Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
Query!
Assessment method [13]
0
0
Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations =24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Query!
Timepoint [13]
0
0
Year 1, Year 2, Year 3, Year 4, Year 5
Query!
Secondary outcome [14]
0
0
Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
Query!
Assessment method [14]
0
0
Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations =24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Query!
Timepoint [14]
0
0
Year 1, Year 2, Year 3, Year 4, Year 5
Query!
Secondary outcome [15]
0
0
Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
Query!
Assessment method [15]
0
0
Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.
Query!
Timepoint [15]
0
0
Year 1, Year 2, Year 3, Year 4, Year 5
Query!
Secondary outcome [16]
0
0
Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
Query!
Assessment method [16]
0
0
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Query!
Timepoint [16]
0
0
Baseline, Month 6, Month 18, Month 30
Query!
Secondary outcome [17]
0
0
Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
Query!
Assessment method [17]
0
0
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Query!
Timepoint [17]
0
0
Baseline, Month 42, Month 54, Month 66
Query!
Secondary outcome [18]
0
0
Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
Query!
Assessment method [18]
0
0
Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.
Query!
Timepoint [18]
0
0
Baseline, Final Visit
Query!
Eligibility
Key inclusion criteria
* Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
* Left ventricular ejection fraction (LVEF) > = 45%
* Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.
Query!
Minimum age
60
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Acute myocardial infarction within 3 months;
* Heart revascularization procedure within 3 months;
* Hospitalization for angina within 3 months;
* Other heart surgery
* Life-threatening or uncontrolled arrhythmia
* Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months;
* Stroke or surgery of the arteries in the brain within 3 months;
* Serious lung disease which requires use of home oxygen.
* Significantly low blood pressure
* Significantly high blood pressure
* Other known diseases that may limit life expectancy to <3 years;
* Known or suspected bilateral kidney artery narrowing;
* Geographic or social factors making study participation and follow-up impractical.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2002
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/07/2008
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
4128
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - Coffs Harbour
Query!
Recruitment hospital [2]
0
0
Local Institution - Concord
Query!
Recruitment hospital [3]
0
0
Local Institution - Garran
Query!
Recruitment hospital [4]
0
0
Local Institution - Kogarah
Query!
Recruitment hospital [5]
0
0
Local Institution - Randwick
Query!
Recruitment hospital [6]
0
0
Local Institution - Auchenflower
Query!
Recruitment hospital [7]
0
0
Local Institution - Brisbane
Query!
Recruitment hospital [8]
0
0
Local Institution - Woolloongabba
Query!
Recruitment hospital [9]
0
0
Local Institution - Launceston
Query!
Recruitment hospital [10]
0
0
Local Institution - Geelong
Query!
Recruitment hospital [11]
0
0
Local Institution - Prahran
Query!
Recruitment postcode(s) [1]
0
0
- Coffs Harbour
Query!
Recruitment postcode(s) [2]
0
0
- Concord
Query!
Recruitment postcode(s) [3]
0
0
- Garran
Query!
Recruitment postcode(s) [4]
0
0
- Kogarah
Query!
Recruitment postcode(s) [5]
0
0
- Randwick
Query!
Recruitment postcode(s) [6]
0
0
- Auchenflower
Query!
Recruitment postcode(s) [7]
0
0
- Brisbane
Query!
Recruitment postcode(s) [8]
0
0
- Woolloongabba
Query!
Recruitment postcode(s) [9]
0
0
- Launceston
Query!
Recruitment postcode(s) [10]
0
0
- Geelong
Query!
Recruitment postcode(s) [11]
0
0
- Prahran
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kentucky
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Louisiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Maine
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Minnesota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Nebraska
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nevada
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Hampshire
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Jersey
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New Mexico
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
New York
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
North Carolina
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Ohio
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Oregon
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Pennsylvania
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Tennessee
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Texas
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Virginia
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Washington
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Wisconsin
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Buenos Aires
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Santa Fe
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Cordoba
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Corrientes
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Mendoza
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Aalst
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
AYE
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Borgerhout
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Genk-waterschei
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Gent
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Hasselt
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
HUY
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Leuven
Query!
Country [46]
0
0
Belgium
Query!
State/province [46]
0
0
Verviers
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Bahia
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
Goias
Query!
Country [49]
0
0
Brazil
Query!
State/province [49]
0
0
Minas Gerais
Query!
Country [50]
0
0
Brazil
Query!
State/province [50]
0
0
Sao Paulo
Query!
Country [51]
0
0
Brazil
Query!
State/province [51]
0
0
Rio de Janeiro
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Alberta
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
British Columbia
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Ontario
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Quebec
Query!
Country [56]
0
0
Czech Republic
Query!
State/province [56]
0
0
Prague 2
Query!
Country [57]
0
0
Czech Republic
Query!
State/province [57]
0
0
Prague 4
Query!
Country [58]
0
0
Czech Republic
Query!
State/province [58]
0
0
Prague 9
Query!
Country [59]
0
0
Czech Republic
Query!
State/province [59]
0
0
Usti Nad Labem
Query!
Country [60]
0
0
Denmark
Query!
State/province [60]
0
0
Copenhagen Nv
Query!
Country [61]
0
0
Denmark
Query!
State/province [61]
0
0
Copenhagen
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Abbeville
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Cholet
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
DAX
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
GAP
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Langres
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Lille
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Montbeliard
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Paris Cedex 13
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Poissy
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Pontoise
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Provins
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Roubaix
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Rouen
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Saint Malo
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Tours
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Vandoeuvre Les Nancy
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Vichy Cedex
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Bad Homburg
Query!
Country [80]
0
0
Germany
Query!
State/province [80]
0
0
Berlin
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Goettingen
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Gunzenhausen
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Halle
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Homburg / Saar
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Jena
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Langen
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Leipzig
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Mainz
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Marburg
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Muenchen
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Regensburg
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Stuttgart
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Witten
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Wuerzburg
Query!
Country [95]
0
0
Greece
Query!
State/province [95]
0
0
Athens
Query!
Country [96]
0
0
Greece
Query!
State/province [96]
0
0
Patras
Query!
Country [97]
0
0
Hungary
Query!
State/province [97]
0
0
Budapest
Query!
Country [98]
0
0
Hungary
Query!
State/province [98]
0
0
Debrecen
Query!
Country [99]
0
0
Hungary
Query!
State/province [99]
0
0
Siofok
Query!
Country [100]
0
0
Hungary
Query!
State/province [100]
0
0
Szeged
Query!
Country [101]
0
0
Ireland
Query!
State/province [101]
0
0
Dublin
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Ascoli Piceno
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
Bologna
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
Brescia
Query!
Country [105]
0
0
Italy
Query!
State/province [105]
0
0
Cosenza
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
Pavia
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
Perugia
Query!
Country [108]
0
0
Italy
Query!
State/province [108]
0
0
Piacenza
Query!
Country [109]
0
0
Italy
Query!
State/province [109]
0
0
Roma
Query!
Country [110]
0
0
Italy
Query!
State/province [110]
0
0
Siena
Query!
Country [111]
0
0
Italy
Query!
State/province [111]
0
0
Trieste
Query!
Country [112]
0
0
Italy
Query!
State/province [112]
0
0
Udine
Query!
Country [113]
0
0
Mexico
Query!
State/province [113]
0
0
Distrito Federal
Query!
Country [114]
0
0
Mexico
Query!
State/province [114]
0
0
Jalisco
Query!
Country [115]
0
0
Mexico
Query!
State/province [115]
0
0
Nuevo Leon
Query!
Country [116]
0
0
Mexico
Query!
State/province [116]
0
0
Aguascalientes
Query!
Country [117]
0
0
Netherlands
Query!
State/province [117]
0
0
Alkmaar
Query!
Country [118]
0
0
Netherlands
Query!
State/province [118]
0
0
Almere
Query!
Country [119]
0
0
Netherlands
Query!
State/province [119]
0
0
Amersfoort
Query!
Country [120]
0
0
Netherlands
Query!
State/province [120]
0
0
Apeldoorn
Query!
Country [121]
0
0
Netherlands
Query!
State/province [121]
0
0
Assen
Query!
Country [122]
0
0
Netherlands
Query!
State/province [122]
0
0
Breda
Query!
Country [123]
0
0
Netherlands
Query!
State/province [123]
0
0
Delft
Query!
Country [124]
0
0
Netherlands
Query!
State/province [124]
0
0
Emmen
Query!
Country [125]
0
0
Netherlands
Query!
State/province [125]
0
0
Gorinchem
Query!
Country [126]
0
0
Netherlands
Query!
State/province [126]
0
0
Groningen
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Heemstede
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
Helmond
Query!
Country [129]
0
0
Netherlands
Query!
State/province [129]
0
0
Hengelo Ov
Query!
Country [130]
0
0
Netherlands
Query!
State/province [130]
0
0
Nijmegen
Query!
Country [131]
0
0
Netherlands
Query!
State/province [131]
0
0
Rotterdam
Query!
Country [132]
0
0
Netherlands
Query!
State/province [132]
0
0
Sittard
Query!
Country [133]
0
0
Netherlands
Query!
State/province [133]
0
0
Sneek
Query!
Country [134]
0
0
Netherlands
Query!
State/province [134]
0
0
Veldhoven
Query!
Country [135]
0
0
Netherlands
Query!
State/province [135]
0
0
Vlaardingen
Query!
Country [136]
0
0
Netherlands
Query!
State/province [136]
0
0
Zaandam
Query!
Country [137]
0
0
Norway
Query!
State/province [137]
0
0
Baerum Postterminal
Query!
Country [138]
0
0
Norway
Query!
State/province [138]
0
0
Stavanger
Query!
Country [139]
0
0
Norway
Query!
State/province [139]
0
0
Tonsberg
Query!
Country [140]
0
0
Poland
Query!
State/province [140]
0
0
Bydgoszcz
Query!
Country [141]
0
0
Poland
Query!
State/province [141]
0
0
Katowice
Query!
Country [142]
0
0
Poland
Query!
State/province [142]
0
0
Piotrkow Tryb.
Query!
Country [143]
0
0
Poland
Query!
State/province [143]
0
0
Stalowa Wola
Query!
Country [144]
0
0
Poland
Query!
State/province [144]
0
0
Warszawa
Query!
Country [145]
0
0
Poland
Query!
State/province [145]
0
0
Wroclaw
Query!
Country [146]
0
0
Portugal
Query!
State/province [146]
0
0
Lisbon
Query!
Country [147]
0
0
Portugal
Query!
State/province [147]
0
0
Matosinhos
Query!
Country [148]
0
0
Russian Federation
Query!
State/province [148]
0
0
Moscow
Query!
Country [149]
0
0
Russian Federation
Query!
State/province [149]
0
0
Saratov
Query!
Country [150]
0
0
Russian Federation
Query!
State/province [150]
0
0
St. Petersburg
Query!
Country [151]
0
0
South Africa
Query!
State/province [151]
0
0
Gauteng
Query!
Country [152]
0
0
South Africa
Query!
State/province [152]
0
0
Kwa Zulu Natal
Query!
Country [153]
0
0
Spain
Query!
State/province [153]
0
0
A Coruna
Query!
Country [154]
0
0
Spain
Query!
State/province [154]
0
0
Barcelona
Query!
Country [155]
0
0
Spain
Query!
State/province [155]
0
0
Cordoba
Query!
Country [156]
0
0
Spain
Query!
State/province [156]
0
0
Madrid
Query!
Country [157]
0
0
Spain
Query!
State/province [157]
0
0
Malaga
Query!
Country [158]
0
0
Spain
Query!
State/province [158]
0
0
Murcia
Query!
Country [159]
0
0
Spain
Query!
State/province [159]
0
0
Palma de Mallorca
Query!
Country [160]
0
0
Spain
Query!
State/province [160]
0
0
Sevilla
Query!
Country [161]
0
0
Spain
Query!
State/province [161]
0
0
Valencia
Query!
Country [162]
0
0
Spain
Query!
State/province [162]
0
0
Zaragoza
Query!
Country [163]
0
0
Sweden
Query!
State/province [163]
0
0
Falun
Query!
Country [164]
0
0
Sweden
Query!
State/province [164]
0
0
Gothenburg
Query!
Country [165]
0
0
Sweden
Query!
State/province [165]
0
0
Linkoping
Query!
Country [166]
0
0
Sweden
Query!
State/province [166]
0
0
Malmo
Query!
Country [167]
0
0
Sweden
Query!
State/province [167]
0
0
Skelleftea
Query!
Country [168]
0
0
Sweden
Query!
State/province [168]
0
0
Stockholm
Query!
Country [169]
0
0
Sweden
Query!
State/province [169]
0
0
Sundsvall
Query!
Country [170]
0
0
Switzerland
Query!
State/province [170]
0
0
Bellinzona
Query!
Country [171]
0
0
Switzerland
Query!
State/province [171]
0
0
Liestal
Query!
Country [172]
0
0
Switzerland
Query!
State/province [172]
0
0
Zuerich
Query!
Country [173]
0
0
United Kingdom
Query!
State/province [173]
0
0
Dumbartonshire
Query!
Country [174]
0
0
United Kingdom
Query!
State/province [174]
0
0
Essex
Query!
Country [175]
0
0
United Kingdom
Query!
State/province [175]
0
0
Yorkshire
Query!
Country [176]
0
0
United Kingdom
Query!
State/province [176]
0
0
Dundee
Query!
Country [177]
0
0
United Kingdom
Query!
State/province [177]
0
0
Londonderry
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Sanofi
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00095238
Query!
Trial related presentations / publications
Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11. Zile MR, Gaasch WH, Anand IS, Haass M, Little WC, Miller AB, Lopez-Sendon J, Teerlink JR, White M, McMurray JJ, Komajda M, McKelvie R, Ptaszynska A, Hetzel SJ, Massie BM, Carson PE; I-Preserve Investigators. Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial. Circulation. 2010 Mar 30;121(12):1393-405. doi: 10.1161/CIRCULATIONAHA.109.909614. Epub 2010 Mar 15. McMurray JJ, Carson PE, Komajda M, McKelvie R, Zile MR, Ptaszynska A, Staiger C, Donovan JM, Massie BM. Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial. Eur J Heart Fail. 2008 Feb;10(2):149-56. doi: 10.1016/j.ejheart.2007.12.010. Carson P, Massie BM, McKelvie R, McMurray J, Komajda M, Zile M, Ptaszynska A, Frangin G; I-PRESERVE Investigators. The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design. J Card Fail. 2005 Oct;11(8):576-85. doi: 10.1016/j.cardfail.2005.06.432. McKelvie RS, Komajda M, McMurray J, Zile M, Ptaszynska A, Donovan M, Carson P, Massie BM; I-Preserve Investigators. Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial. J Card Fail. 2010 Feb;16(2):128-34. doi: 10.1016/j.cardfail.2009.09.007. Epub 2009 Nov 4. Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10. Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052. Kristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766. Kristensen SL, Mogensen UM, Jhund PS, Petrie MC, Preiss D, Win S, Kober L, McKelvie RS, Zile MR, Anand IS, Komajda M, Gottdiener JS, Carson PE, McMurray JJ. Clinical and Echocardiographic Characteristics and Cardiovascular Outcomes According to Diabetes Status in Patients With Heart Failure and Preserved Ejection Fraction: A Report From the I-Preserve Trial (Irbesartan in Heart Failure With Preserved Ejection Fraction). Circulation. 2017 Feb 21;135(8):724-735. doi: 10.1161/CIRCULATIONAHA.116.024593. Epub 2017 Jan 4. Gandhi PU, Chow SL, Rector TS, Krum H, Gaggin HK, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Carson PE, Januzzi JL Jr, Anand IS. Prognostic Value of Insulin-Like Growth Factor-Binding Protein 7 in Patients with Heart Failure and Preserved Ejection Fraction. J Card Fail. 2017 Jan;23(1):20-28. doi: 10.1016/j.cardfail.2016.06.006. Epub 2016 Jun 16. Badar AA, Perez-Moreno AC, Hawkins NM, Jhund PS, Brunton AP, Anand IS, McKelvie RS, Komajda M, Zile MR, Carson PE, Gardner RS, Petrie MC, McMurray JJ. Clinical Characteristics and Outcomes of Patients With Coronary Artery Disease and Angina: Analysis of the Irbesartan in Patients With Heart Failure and Preserved Systolic Function Trial. Circ Heart Fail. 2015 Jul;8(4):717-24. doi: 10.1161/CIRCHEARTFAILURE.114.002024. Epub 2015 Jun 11. Oluleye OW, Rector TS, Win S, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Massie B, Carson PE, Anand IS. History of atrial fibrillation as a risk factor in patients with heart failure and preserved ejection fraction. Circ Heart Fail. 2014 Nov;7(6):960-6. doi: 10.1161/CIRCHEARTFAILURE.114.001523. Epub 2014 Sep 15. Bohm M, Perez AC, Jhund PS, Reil JC, Komajda M, Zile MR, McKelvie RS, Anand IS, Massie BM, Carson PE, McMurray JJ; I-Preserve Committees and Investigators. Relationship between heart rate and mortality and morbidity in the irbesartan patients with heart failure and preserved systolic function trial (I-Preserve). Eur J Heart Fail. 2014 Jul;16(7):778-87. doi: 10.1002/ejhf.85. Epub 2014 May 23. Lam CS, Carson PE, Anand IS, Rector TS, Kuskowski M, Komajda M, McKelvie RS, McMurray JJ, Zile MR, Massie BM, Kitzman DW. Sex differences in clinical characteristics and outcomes in elderly patients with heart failure and preserved ejection fraction: the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Circ Heart Fail. 2012 Sep 1;5(5):571-8. doi: 10.1161/CIRCHEARTFAILURE.112.970061. Epub 2012 Aug 10. Rector TS, Carson PE, Anand IS, McMurray JJ, Zile MR, McKelvie RS, Komajda M, Kuskowski M, Massie BM; I-PRESERVE Trial Investigators. Assessment of long-term effects of irbesartan on heart failure with preserved ejection fraction as measured by the minnesota living with heart failure questionnaire in the irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial. Circ Heart Fail. 2012 Mar 1;5(2):217-25. doi: 10.1161/CIRCHEARTFAILURE.111.964221. Epub 2012 Jan 20. Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7. Krum H, Elsik M, Schneider HG, Ptaszynska A, Black M, Carson PE, Komajda M, Massie BM, McKelvie RS, McMurray JJ, Zile MR, Anand IS. Relation of peripheral collagen markers to death and hospitalization in patients with heart failure and preserved ejection fraction: results of the I-PRESERVE collagen substudy. Circ Heart Fail. 2011 Sep;4(5):561-8. doi: 10.1161/CIRCHEARTFAILURE.110.960716. Epub 2011 Jul 12. Anand IS, Rector TS, Cleland JG, Kuskowski M, McKelvie RS, Persson H, McMurray JJ, Zile MR, Komajda M, Massie BM, Carson PE. Prognostic value of baseline plasma amino-terminal pro-brain natriuretic peptide and its interactions with irbesartan treatment effects in patients with heart failure and preserved ejection fraction: findings from the I-PRESERVE trial. Circ Heart Fail. 2011 Sep;4(5):569-77. doi: 10.1161/CIRCHEARTFAILURE.111.962654. Epub 2011 Jun 29. Haass M, Kitzman DW, Anand IS, Miller A, Zile MR, Massie BM, Carson PE. Body mass index and adverse cardiovascular outcomes in heart failure patients with preserved ejection fraction: results from the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Circ Heart Fail. 2011 May;4(3):324-31. doi: 10.1161/CIRCHEARTFAILURE.110.959890. Epub 2011 Feb 24. Komajda M, Carson PE, Hetzel S, McKelvie R, McMurray J, Ptaszynska A, Zile MR, Demets D, Massie BM. Factors associated with outcome in heart failure with preserved ejection fraction: findings from the Irbesartan in Heart Failure with Preserved Ejection Fraction Study (I-PRESERVE). Circ Heart Fail. 2011 Jan;4(1):27-35. doi: 10.1161/CIRCHEARTFAILURE.109.932996. Epub 2010 Nov 10.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Massie BM, Carson PE, McMurray JJ, Komajda M, McKe...
[
More Details
]
Journal
Zile MR, Gaasch WH, Anand IS, Haass M, Little WC, ...
[
More Details
]
Journal
McMurray JJ, Carson PE, Komajda M, McKelvie R, Zil...
[
More Details
]
Journal
Carson P, Massie BM, McKelvie R, McMurray J, Komaj...
[
More Details
]
Journal
McKelvie RS, Komajda M, McMurray J, Zile M, Ptaszy...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00095238
Download to PDF