Clinical trial NCT01273259: Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
Official title: Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Hypertension, Pulmonary
Keywords: Hypertension, pulmonary
DHEA
six-minute walk test
pulmonary arterial pressure
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-01-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Efficacy of DHEA on exercise capacity (six-minute walk test)
timeFrame: inclusion and one year of treatment
Secondary outcomes:
measure: Pulmonary and systemic arterial pressures (mean, systolic and diastolic)
timeFrame: Inclusion and after one year of treatment
measure: Pulmonary vascular resistances
timeFrame: Inclusion and after one year of treatment
measure: Safety / Compliance
timeFrame: along one year of treatment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital, Bordeaux
city: Limoges
country: France
facility: CHU de Limoges
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
References: