Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
NCT01273259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2026-05-14
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.
Conditions
- Chronic Obstructive Pulmonary Disease
- Hypertension, Pulmonary
Interventions
- DRUG
-
DHEA Treatment
DHEA : 200 mg/day hard gelatine capsule
- DRUG
-
DHEA Treatment
DHEA : 25 mg/day hard gelatine capsule
Sponsors & Collaborators
-
University Hospital, Bordeaux
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-06
- Primary Completion
- 2015-06-05
- Completion
- 2015-06-05
Countries
- France
Study Locations
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