Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension (FONCE-HTAP)

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: Pulmonary Arterial Hypertension
• Intervention / Treatment: Behavioral: Rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: intervention; Rehabilitation	Behavioral: Rehabilitation; Other Names: Supervised rehabilitation

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),	12 months after the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right ventricular ejection fraction evaluated by RMN		at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism	cardiac index (L/min/m²)	at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism	pressure in the right atrium (mmHg)	at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism	pulmonary resistance (uw)	at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism	mean pulmonary arterial pressure (mmHg)	at 3 and 12 months
Functional class (NYHA classification)		at 3 and 12 months
6 minutes walking distance (m)		at 3 and 12 months
Functional exercise capacity (oxygen consumption measurement during test)		at 3 and 12 months
Quality of life (SF-36 scale)		at 3 and 12 months
Time to clinical worsening (months)		at 3 and 12 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Laurent BERTOLETTI, MD PhD, Chu de Saint Etienne

Study record dates

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: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension
• 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