Clinical trial NCT02579954: Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension
Official title: Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2015-10-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),
timeFrame: 12 months after the inclusion
Secondary outcomes:
measure: Right ventricular ejection fraction evaluated by RMN
timeFrame: at 3 and 12 months
measure: Pulmonary haemodynamics : measurements at right heart catheterism
timeFrame: at 3 and 12 months
measure: Pulmonary haemodynamics : measurements at right heart catheterism
timeFrame: at 3 and 12 months
measure: Pulmonary haemodynamics : measurements at right heart catheterism
timeFrame: at 3 and 12 months
measure: Pulmonary haemodynamics : measurements at right heart catheterism
timeFrame: at 3 and 12 months
measure: Functional class (NYHA classification)
timeFrame: at 3 and 12 months
measure: 6 minutes walking distance (m)
timeFrame: at 3 and 12 months
measure: Functional exercise capacity (oxygen consumption measurement during test)
timeFrame: at 3 and 12 months
measure: Quality of life (SF-36 scale)
timeFrame: at 3 and 12 months
measure: Time to clinical worsening (months)
timeFrame: at 3 and 12 months
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de Besançon
city: Brest
country: France
facility: CHU de Brest
city: Clermont Ferrand
country: France
facility: CHU Gabriel Montpied
city: Echirolles
country: France
facility: Hôpital Sud de Grenoble
city: Grenoble
country: France
facility: Hôpital Nord de Grenoble
city: Lyon
country: France
facility: HCL - Hôpital Louis Pradel
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: APHP - Hôpital Bicêtre
city: Saint Etienne
country: France
facility: Chu de Saint Etienne
city: Strasbourg
country: France
facility: CHRU de Strasbourg
Study officials:
affiliation: CHU de Saint Etienne
name: Laurent BERTOLETTI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: