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

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Hypertension, Pulmonary
• Interventions: Drug: DHEA Treatment

• Registration Number: NCT01273259
• Lead Sponsor: University Hospital, Bordeaux

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-06
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2015-06-05
• Study Completion: 2015-06-05
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Age ≥ 18 years old and ≤ 75 years old
• Chronic Obstructive Pulmonary Disease with FEVs/VC < 70% (*)
• Respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 20 mmHg (*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
• PO2 ≤ 70 mmHg assessed by arterial gasometry at ease
• If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening
• Written informed consent

(*) Criteria assessed from last health check or the last exams for COPD diagnosis

Exclusion Criteria

• clinical instability and/or respiratory exacerbation dangerous for catheterization
• Pregnancy (ßHCG > 20 UI /l) or breastfeeding on going
• General corticotherapy > 0,5 mg/kg/day prednisolon equivalent
• Hepatic insufficiency (TP < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)
• Left-heart failure (coronary heart disease and/or left valvulopathy)
• High level of prostatic specific antigen (PSA) (> 7ng/ml)
• Cancer antecedent or treatment on going

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
200 mg /day arm	DHEA Treatment	-
25 mg/day arm	DHEA Treatment	-

Primary Outcome Measures

Name	Time	Method
Efficacy of DHEA on exercise capacity (six-minute walk test)	inclusion and one year of treatment

Secondary Outcome Measures

Name	Time	Method
Pulmonary and systemic arterial pressures (mean, systolic and diastolic)	Inclusion and after one year of treatment
Pulmonary vascular resistances	Inclusion and after one year of treatment
Safety / Compliance	along one year of treatment

Trial Locations

Locations (4)

CHU de Strasbourg; 🇫🇷 Strasbourg, France

CHU de Limoges; 🇫🇷 Limoges, France

CHU de Toulouse; 🇫🇷 Toulouse, France

University Hospital, Bordeaux; 🇫🇷 Bordeaux, France