Pulmonary Arterial Hypertension Clinical Trial
— FONCE-HTAPOfficial title:
Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Saint Etienne | Ministry of Health, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET), | 12 months after the inclusion | ||
| Secondary | Right ventricular ejection fraction evaluated by RMN | at 3 and 12 months | ||
| Secondary | Pulmonary haemodynamics : measurements at right heart catheterism | cardiac index (L/min/m²) | at 3 and 12 months | |
| Secondary | Pulmonary haemodynamics : measurements at right heart catheterism | pressure in the right atrium (mmHg) | at 3 and 12 months | |
| Secondary | Pulmonary haemodynamics : measurements at right heart catheterism | pulmonary resistance (uw) | at 3 and 12 months | |
| Secondary | Pulmonary haemodynamics : measurements at right heart catheterism | mean pulmonary arterial pressure (mmHg) | at 3 and 12 months | |
| Secondary | Functional class (NYHA classification) | at 3 and 12 months | ||
| Secondary | 6 minutes walking distance (m) | at 3 and 12 months | ||
| Secondary | Functional exercise capacity (oxygen consumption measurement during test) | at 3 and 12 months | ||
| Secondary | Quality of life (SF-36 scale) | at 3 and 12 months | ||
| Secondary | Time to clinical worsening (months) | at 3 and 12 months |
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