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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03954574




Registration number
NCT03954574
Ethics application status
Date submitted
14/03/2019
Date registered
17/05/2019

Titles & IDs
Public title
Pulmonary Hemodynamics During Exercise - Research Network
Scientific title
Pulmonary Hemodynamics During Exercise - Research Network
Secondary ID [1] 0 0
30-437 ex 17/18
Universal Trial Number (UTN)
Trial acronym
PEX-NET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Circulation Diseases 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - assessment of pulmonary hemodynamics during exercise by right heart catheterization

Retrospective patient cohort -

Prospective patient cohort -


Diagnosis / Prognosis: assessment of pulmonary hemodynamics during exercise by right heart catheterization
all patients undergo right heart catheterization during exercise due to clinical reasons. Results of this and other Routine clinical tests will be included in the registry
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants who die during observation
Timepoint [1] 0 0
6 years
Primary outcome [2] 0 0
Number of Participants undergoing lung Transplantation during observation
Timepoint [2] 0 0
6 years
Secondary outcome [1] 0 0
Number of Participants being hospitalized during observation
Timepoint [1] 0 0
6 years
Secondary outcome [2] 0 0
Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization
Timepoint [2] 0 0
6 years
Secondary outcome [3] 0 0
Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation
Timepoint [3] 0 0
6 years

Eligibility
Key inclusion criteria
* Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for RHC at rest and exercise
* Written informed consent of participating subjects after being fully briefed (for prospective analysis)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with incomplete hemodynamic data at rest or exercise
* Patients without sufficient follow-up data (information on survival / lung transplantation)
* advanced tumour disease or other diseases with a short life expectancy, except pulmonary vascular diseases
* advanced heart failure with pulmonary arterial wedge pressure (PAWP) > 18 mmHg at rest
* uncontrolled systemic arterial hypertension (RR values > 160/100 mmHg at rest)
* FEV1<50% predicted
* TLC<60% predicted

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital, Respiratory Medicine - Camperdown
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
Austria
State/province [7] 0 0
Graz
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Brazil
State/province [9] 0 0
São Paulo
Country [10] 0 0
Denmark
State/province [10] 0 0
Aarhus
Country [11] 0 0
France
State/province [11] 0 0
Nancy
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
Germany
State/province [13] 0 0
Cologne
Country [14] 0 0
Germany
State/province [14] 0 0
Gießen
Country [15] 0 0
Germany
State/province [15] 0 0
Greifswald
Country [16] 0 0
Germany
State/province [16] 0 0
Heidelberg
Country [17] 0 0
Germany
State/province [17] 0 0
Würzburg
Country [18] 0 0
Italy
State/province [18] 0 0
Bologna
Country [19] 0 0
Italy
State/province [19] 0 0
Roma
Country [20] 0 0
Netherlands
State/province [20] 0 0
Amsterdam
Country [21] 0 0
Poland
State/province [21] 0 0
Otwock
Country [22] 0 0
Spain
State/province [22] 0 0
Barcelona
Country [23] 0 0
Switzerland
State/province [23] 0 0
Zürich
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Glasgow
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
Medical University of Graz
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
European Respiratory Society
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Horst Olschewski, MD
Address 0 0
Medical University of Graz
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gabor Kovacs, MD
Address 0 0
Country 0 0
Phone 0 0
+43-316-385
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03954574