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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT01273259

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

12.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Hypertension, Pulmonary	Drug: DHEA Treatment Drug: DHEA Treatment	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 6, 2008

Actual Primary Completion Date :

Jun 5, 2015

Actual Study Completion Date :

Jun 5, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 200 mg /day arm	Drug: DHEA Treatment DHEA : 200 mg/day hard gelatine capsule
Experimental: 25 mg/day arm	Drug: DHEA Treatment DHEA : 25 mg/day hard gelatine capsule

Arm

Intervention/Treatment

Experimental: 200 mg /day arm

Drug: DHEA Treatment

DHEA : 200 mg/day hard gelatine capsule

Experimental: 25 mg/day arm

Drug: DHEA Treatment

DHEA : 25 mg/day hard gelatine capsule

Outcome Measures

Primary Outcome Measures

Efficacy of DHEA on exercise capacity (six-minute walk test) [inclusion and one year of treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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