Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

NCT ID: NCT02579954

Last Updated: 2024-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-06

Study Completion Date

2024-01-24

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.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention

Rehabilitation

Group Type EXPERIMENTAL

Rehabilitation

Intervention Type BEHAVIORAL

Interventions

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Rehabilitation

Intervention Type BEHAVIORAL

Other Intervention Names

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Supervised rehabilitation

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent BERTOLETTI, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Locations

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CHU de Besançon

Besançon, , France

Site Status

CHU de Brest

Brest, , France

Site Status

CHU Gabriel Montpied

Clermont-Ferrand, , France

Site Status

Hôpital Sud de Grenoble

Échirolles, , France

Site Status

Hôpital Nord de Grenoble

Grenoble, , France

Site Status

HCL - Hôpital Louis Pradel

Lyon, , France

Site Status

CHU de Montpellier

Montpellier, , France

Site Status

APHP - Hôpital Bicêtre

Paris, , France

Site Status

Chu de Saint Etienne

Saint-Etienne, , France

Site Status

CHRU de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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2014-A00169-38

Identifier Type: OTHER

Identifier Source: secondary_id

1308156

Identifier Type: -

Identifier Source: org_study_id

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