Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

Not Applicable

Completed

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Behavioral: Rehabilitation

• Registration Number: NCT02579954
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-06
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Primary Completion: 2022-12-05
• Study Completion: 2024-01-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention	Rehabilitation	Rehabilitation

Primary Outcome Measures

Name	Time	Method
Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),	12 months after the inclusion

Secondary Outcome Measures

Name	Time	Method
Functional class (NYHA classification)	at 3 and 12 months
Time to clinical worsening (months)	at 3 and 12 months
6 minutes walking distance (m)	at 3 and 12 months
Right ventricular ejection fraction evaluated by RMN	at 3 and 12 months
Functional exercise capacity (oxygen consumption measurement during test)	at 3 and 12 months
Pulmonary haemodynamics : measurements at right heart catheterism	at 3 and 12 months	mean pulmonary arterial pressure (mmHg)
Quality of life (SF-36 scale)	at 3 and 12 months

Trial Locations

Locations (10)

CHU de Besançon; 🇫🇷 Besancon, France

CHU de Brest; 🇫🇷 Brest, France

CHU Gabriel Montpied; 🇫🇷 Clermont Ferrand, France

Hôpital Sud de Grenoble; 🇫🇷 Echirolles, France

Hôpital Nord de Grenoble; 🇫🇷 Grenoble, France

HCL - Hôpital Louis Pradel; 🇫🇷 Lyon, France

CHU de Montpellier; 🇫🇷 Montpellier, France

APHP - Hôpital Bicêtre; 🇫🇷 Paris, France

Chu de Saint Etienne; 🇫🇷 Saint Etienne, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France