Pulmonary Arterial Hypertension
Conditions
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.
Interventions
BEHAVIORALRehabilitation
Sponsors
Ministry of Health, France
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET), | 12 months after the inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary haemodynamics : measurements at right heart catheterism | at 3 and 12 months | cardiac index (L/min/m²) |
| Functional class (NYHA classification) | 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 | — |
| Quality of life (SF-36 scale) | at 3 and 12 months | — |
| Time to clinical worsening (months) | at 3 and 12 months | — |
| Functional exercise capacity (oxygen consumption measurement during test) | at 3 and 12 months | — |
Countries
France
Outcome results
None listed