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COMPLETED
NCT01273259
PHASE2

Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults (DHEA-HTAP)

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.

Official title: Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

51

Start Date

2008-05-06

Completion Date

2015-06-05

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

DRUG

DHEA Treatment

DHEA : 200 mg/day hard gelatine capsule

DRUG

DHEA Treatment

DHEA : 25 mg/day hard gelatine capsule

Locations (4)

University Hospital, Bordeaux

Bordeaux, France

CHU de Limoges

Limoges, France

CHU de Strasbourg

Strasbourg, France

CHU de Toulouse

Toulouse, France