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

NCT ID: NCT01273259

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-06
• Study Completion Date: 2015-06-05

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.

Conditions

Chronic Obstructive Pulmonary Disease; Hypertension, Pulmonary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

200 mg /day arm

Group Type: EXPERIMENTAL

DHEA Treatment

Intervention Type: DRUG

DHEA : 200 mg/day hard gelatine capsule

25 mg/day arm

Group Type: EXPERIMENTAL

DHEA Treatment

Intervention Type: DRUG

DHEA : 25 mg/day hard gelatine capsule

Interventions

DHEA Treatment

DHEA : 200 mg/day hard gelatine capsule

Intervention Type: DRUG

DHEA Treatment

DHEA : 25 mg/day hard gelatine capsule

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

University Hospital, Bordeaux

Locations

University Hospital, Bordeaux

Bordeaux, , France

CHU de Limoges

Limoges, , France

CHU de Strasbourg

Strasbourg, , France

CHU de Toulouse

Toulouse, , France

Countries

France

Other Identifiers

CHUBX 2003/04

Identifier Type: -

Identifier Source: org_study_id