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

University Hospital of Bordeaux

Status and phase

Completed

Phase 2

Conditions

Hypertension, Pulmonary

Chronic Obstructive Pulmonary Disease

Treatments

Drug: DHEA Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01273259

CHUBX 2003/04

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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