Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults (DHEA-HTAP) (NCT01273259) | Clinical Trial Compass
CompletedPhase 2
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults (DHEA-HTAP)
France51 participantsStarted 2008-05-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a hormone supplement called DHEA in people with pulmonary hypertension related to COPD — since it's a completed Phase 2 study, what did the results show about whether DHEA actually improved how far patients could walk in six minutes?
2Phase 2 trials are mainly designed to test whether a treatment shows early signs of working and to gather safety data — given that, how confident can we be about DHEA's safety and effectiveness for pulmonary hypertension in COPD based on this study alone?
3DHEA is a hormone that can affect many systems in the body — are there specific risks or side effects from taking it that I should be aware of given my own health history?
4Are there currently approved or standard treatments for pulmonary hypertension associated with COPD that might be worth trying before considering something like DHEA, which is still being studied?
5Since this trial has already been completed, is there any published data from it that you could review with me, and has it led to any follow-up Phase 3 trials that might be more relevant to my situation now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of DHEA on exercise capacity (six-minute walk test)