Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Behavioral: Rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br> | |
| Experimental: intervention<br>Rehabilitation | Behavioral: Rehabilitation<br> <br> * Other names: Supervised rehabilitation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |