Chronic Obstructive Pulmonary Disease, Hypertension, Pulmonary
Conditions
Keywords
Hypertension, pulmonary, DHEA, six-minute walk test, pulmonary arterial pressure
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.
Interventions
DRUGDHEA Treatment
DHEA : 200 mg/day hard gelatine capsule
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of DHEA on exercise capacity (six-minute walk test) | inclusion and one year of treatment |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed