NCT01273259

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	DHEA Treatment	DHEA : 200 mg/day hard gelatine capsule
DRUG	DHEA Treatment	DHEA : 25 mg/day hard gelatine capsule

Timeline

• Start date: 2008-05-06
• Primary completion: 2015-06-05
• Completion: 2015-06-05
• First posted: 2011-01-10
• Last updated: 2022-02-09

Locations

4 sites across 1 country: France