Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension (FONCE-HTAP)
June 24, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance.
We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with pulmonary arterial hypertension, and their evolution at three and twelve months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Besancon, France, 25000
- CHU de Besançon
-
Brest, France, 39609
- CHU de Brest
-
Clermont Ferrand, France, 63000
- Chu Gabriel Montpied
-
Echirolles, France, 38130
- Hôpital Sud de Grenoble
-
Grenoble, France, 38043
- Hôpital Nord de Grenoble
-
Lyon, France
- HCL - Hôpital Louis Pradel
-
Montpellier, France, 34295
- CHU de Montpellier
-
Paris, France
- ApHp - Hôpital Bicêtre
-
Saint Etienne, France, 42055
- CHU de Saint Etienne
-
Strasbourg, France, 67091
- Chru de Strasbourg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult patients
- Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens),
- Prevalent cases of pulmonary artery hypertension (≥ 6 months) confirmed by right heart catheterism,
- Stable for at least 3 months,
- Written consent.
Exclusion Criteria:
- Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc).
- Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Experimental: intervention
Rehabilitation
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),
Time Frame: 12 months after the inclusion
|
12 months after the inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Right ventricular ejection fraction evaluated by RMN
Time Frame: at 3 and 12 months
|
at 3 and 12 months
|
|
|
Pulmonary haemodynamics : measurements at right heart catheterism
Time Frame: at 3 and 12 months
|
cardiac index (L/min/m²)
|
at 3 and 12 months
|
|
Pulmonary haemodynamics : measurements at right heart catheterism
Time Frame: at 3 and 12 months
|
pressure in the right atrium (mmHg)
|
at 3 and 12 months
|
|
Pulmonary haemodynamics : measurements at right heart catheterism
Time Frame: at 3 and 12 months
|
pulmonary resistance (uw)
|
at 3 and 12 months
|
|
Pulmonary haemodynamics : measurements at right heart catheterism
Time Frame: at 3 and 12 months
|
mean pulmonary arterial pressure (mmHg)
|
at 3 and 12 months
|
|
Functional class (NYHA classification)
Time Frame: at 3 and 12 months
|
at 3 and 12 months
|
|
|
6 minutes walking distance (m)
Time Frame: at 3 and 12 months
|
at 3 and 12 months
|
|
|
Functional exercise capacity (oxygen consumption measurement during test)
Time Frame: at 3 and 12 months
|
at 3 and 12 months
|
|
|
Quality of life (SF-36 scale)
Time Frame: at 3 and 12 months
|
at 3 and 12 months
|
|
|
Time to clinical worsening (months)
Time Frame: at 3 and 12 months
|
at 3 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Laurent BERTOLETTI, MD PhD, CHU de Saint Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2015
Primary Completion (Actual)
December 5, 2022
Study Completion (Actual)
January 24, 2024
Study Registration Dates
First Submitted
October 15, 2015
First Submitted That Met QC Criteria
October 19, 2015
First Posted (Estimated)
October 20, 2015
Study Record Updates
Last Update Posted (Actual)
June 25, 2024
Last Update Submitted That Met QC Criteria
June 24, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1308156
- 2014-A00169-38 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.