Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension
FONCE-HTAP
2 other identifiers
interventional
49
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 6, 2015
CompletedFirst Submitted
Initial submission to the registry
October 15, 2015
CompletedFirst Posted
Study publicly available on registry
October 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2024
CompletedJune 25, 2024
June 1, 2024
7.3 years
October 15, 2015
June 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),
12 months after the inclusion
Secondary Outcomes (10)
Right ventricular ejection fraction evaluated by RMN
at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism
at 3 and 12 months
- +5 more secondary outcomes
Study Arms (2)
control group
NO INTERVENTIONintervention
EXPERIMENTALRehabilitation
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CHU de Besançon
Besançon, 25000, France
CHU de Brest
Brest, 39609, France
CHU Gabriel Montpied
Clermont-Ferrand, 63000, France
Hôpital Sud de Grenoble
Échirolles, 38130, France
Hôpital Nord de Grenoble
Grenoble, 38043, France
HCL - Hôpital Louis Pradel
Lyon, France
CHU de Montpellier
Montpellier, 34295, France
APHP - Hôpital Bicêtre
Paris, France
Chu de Saint Etienne
Saint-Etienne, 42055, France
CHRU de Strasbourg
Strasbourg, 67091, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent BERTOLETTI, MD PhD
CHU de Saint Etienne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2015
First Posted
October 20, 2015
Study Start
August 6, 2015
Primary Completion
December 5, 2022
Study Completion
January 24, 2024
Last Updated
June 25, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share