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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease, Hypertension, Pulmonary

Intervention / Treatment
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* Drug: DHEA Treatment
* Drug: DHEA Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg /day arm<br> | Drug: DHEA Treatment<br>* DHEA : 200 mg/day hard gelatine capsule<br>|
| Experimental: 25 mg/day arm<br> | Drug: DHEA Treatment<br>* DHEA : 25 mg/day hard gelatine capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of DHEA on exercise capacity (six-minute walk test) |  | inclusion and one year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DHEA, Hypertension, pulmonary, six-minute walk test, pulmonary arterial pressure