Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000442202
Ethics application status
Approved
Date submitted
5/05/2009
Date registered
12/06/2009
Date last updated
26/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of Physiological Techniques in Heart Failure Management
Scientific title
A randomised controlled trial to assess whether the use of physiologic testing to guide intensity of a Heart Failure Management Program (including the combination of isosorbide mononitrate and hydralazine to the contemporary medical regimen) leads to better outcomes over 2 years follow-up.
Secondary ID [1] 852 0
Nil
Universal Trial Number (UTN)
Trial acronym
GuidedHeart
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart failure 236986 0
Condition category
Condition code
Cardiovascular 237044 237044 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lifestyle intervention: intensive heart failure education over 12 weeks by study nurses to encourage a life-time low salt diet, fluid monitoring and regular daily exercise as tolerated, as well as awareness of symptoms of exacerbation of heart failure and knowledge of disease process. Two weekly phone calls for 2 years after randomisation by study nurse to monitor health status and provide encouragement. Titration of medications by a cardiologist at monthly visits, guided by echocardiography. Functional status as measured by oxygen uptake and exercise stress test and 6 minute walk test prior to randomisation and at one and two years, blood testing to monitor renal & liver function and B-type natriuretic peptile (BNP) level during titration of medication, at randomisation and at one and two years
Intervention code [1] 4488 0
Treatment: Drugs
Intervention code [2] 4489 0
Lifestyle
Intervention code [3] 4490 0
Behaviour
Comparator / control treatment
Those enrolled participants who exhibit remodelling (unresponsive to drug therapy) once fully titrated on heart failure medications (Angiotensin Converting Enzyme [ACE] Inhibitors and Beta Blockers), as per echocardiography, or whose B-type natiruretic peptide levels remain elevated will be randomised to one of two arms:
Arm #1 will undergo further echocardiography and functional testing at 12months and 24months. They will receive the usual care and monitoring provided by their own General Practitioner (GP) or cardiologist and the outpatient heart failure care provided by the hospital heart failure services if they chose to enrol in this program.
Arm #2 - An intensive disease management program as outlined in the intervenion (above). A further randomisation will occur within this group (for eligible participants - not taking hydralazine and nitrates for another purpose and whose blood pressure is considered acceptable by the investigator) to receive hydralazine and nitrates in addition to the standard medication regime for heart failure or placebo. The participants will be monitored 2 weekly initially for 3 visits and thereafter monthly by the study investigator as long as considered necessary. At 12 months all patients will cross over to the alternative of either active or placebo medication. All eligible Arm #2 participants will be given 12months of active hydralazine and nitrate and 12 months of placebo. The placebo consists of an inactive substance (a sugar pill) and will look similar to the active medication. Eligible participants will commence on 25mg twice daily of hydralazine and be uptitrated to 50mg twice daily as tolerated, as well as 60mg of nitrate daily and be uptitrated to 120mg daily as tolerated. All medications are oral tablets.
Control group
Active

Outcomes
Primary outcome [1] 5885 0
The primary (composite) end-point of this study is event-free survival from death or unplanned readmission assessed from patient medical notes
Timepoint [1] 5885 0
1 and 2 years from randomisation
Secondary outcome [1] 241917 0
The secondary endpoint will be improvement of Left Ventricular (LV) volumes and functional capacity in the monitored group as assessed by echocardiography, VO2 (oxygen uptake during exercise) testing exercise stress testing, 6 minute walk test, self care and knowledge questionnaires
Timepoint [1] 241917 0
1 and 2 years from randomisation
Secondary outcome [2] 242278 0
use of appropriate medical therapy for comorbidity assessed by physician monitoring
Timepoint [2] 242278 0
1 and 2 years
Secondary outcome [3] 242279 0
functional status assessed by oxygen and exercise stress testing, 6 minute walk test and questionnaires
Timepoint [3] 242279 0
1and 2 years
Secondary outcome [4] 242280 0
each component of the composite endpoint:
a. all-cause mortality
b. Congestive heart failure related non-fatal hospital admissions
c. Congestive heart failure fatal events
- assessed from hospital medical records
Timepoint [4] 242280 0
1 and 2 years
Secondary outcome [5] 242281 0
Quality of Life assessed by questionnaires
Timepoint [5] 242281 0
1 and 2 years

Eligibility
Key inclusion criteria
Age >=40 years
Diagnosis of Heart Failure
Not suitable for cardiac resynchronisation therapy
Not suitable for revascularisation
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suitable for revascularisation
Suitable for cardiac resynchronisation therapy
No diagnosis of heart failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised using a computerised sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
11/05/2009
Actual
11/05/2009
Date of last participant enrolment
Anticipated
Actual
11/05/2010
Date of last data collection
Anticipated
Actual
11/05/2010
Sample size
Target
360
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 4901 0
Government body
Name [1] 4901 0
National Health and Medical Research Council
Country [1] 4901 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 4433 0
None
Name [1] 4433 0
Address [1] 4433 0
Country [1] 4433 0
Other collaborator category [1] 664 0
Other
Name [1] 664 0
Baker Heart Institute
Address [1] 664 0
75 Commercial Road, Central Melbourne. Vic 8008
Country [1] 664 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6964 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 6964 0
Ethics committee country [1] 6964 0
Australia
Date submitted for ethics approval [1] 6964 0
Approval date [1] 6964 0
07/04/2009
Ethics approval number [1] 6964 0
2008/220

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29570 0
Prof Professor Thomas Marwick
Address 29570 0
Cardiovascular Imaging Research Centre of UniverSity of Queensland (CIRCUS) Group School of Medicine University of Queensland Princess Alexandra Hospital Ipswich Road Wooloongabba 4102 Queensland
Country 29570 0
Australia
Phone 29570 0
+617 32406146 Mob: +61 466136978
Fax 29570 0
+617 32405399
Email 29570 0
[email protected]
Contact person for public queries
Name 12817 0
Julie Holliday
Address 12817 0
Cardiovascular Imaging Research
Centre of UniverSity of Queensland (CIRCUS) Group
School of Medicine
University of Queensland
Princess Alexandra Hospital
Ipswich Road
Wooloongabba 4102
Queensland
Country 12817 0
Australia
Phone 12817 0
Tel; +617 32406146 Mob: +61 466136978
Fax 12817 0
Fax +617 32405399
Email 12817 0
[email protected]
Contact person for scientific queries
Name 3745 0
Professor Thomas Marwick
Address 3745 0
Cardiovascular Imaging Research
Centre of UniverSity of Queensland
(CIRCUS) Group
School of Medicine
University of Queensland
Princess Alexandra Hospital
Ipswich Road
Wooloongabba 4102
Country 3745 0
Australia
Phone 3745 0
Tel; +617 32405340
Fax 3745 0
Fax +617 32405399
Email 3745 0
[email protected]

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

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