Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

Centre Hospitalier Universitaire de Saint Etienne10 sites in 1 country49 target enrollmentAugust 6, 2015

ConditionsPulmonary Arterial Hypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Arterial Hypertension
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Enrollment: 49
Locations: 10
Primary Endpoint: Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 6, 2015

End Date

January 24, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),

Time Frame: 12 months after the inclusion

Secondary Outcomes

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)
Functional exercise capacity (oxygen consumption measurement during test)(at 3 and 12 months)
Time to clinical worsening (months)(at 3 and 12 months)
Pulmonary haemodynamics : measurements at right heart catheterism(at 3 and 12 months)
Quality of life (SF-36 scale)(at 3 and 12 months)