Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
Status:
Unknown status
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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
randomization either 200 mg oral DHEA or placebo 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,
randomized, placebo controlled study which will be realized in four university hospitals in
France : Bordeaux, Strasbourg, Toulouse and Limoges.
Eight patients with pulmonary hypertension (New York Heart Association functional class III
or IV) associated with COPD were included in a pilot study between 2004 and 2005. Inclusion
criteria were: COPD was defined by FEV1/FVC < 70% of reference values; resting mean pulmonary
artery pressure (assessment by right pulmonary catheterization) ≥ 25mmHg with mean pulmonary
capillary wedge pressure ≤ 15mmHg, PaO2 ≤ 60mmHg at rest or PaO2 ≥ 60mmHg associated with
significant fall in O2 saturation with exercise; oxygen treatment initiated more than six
months previously. Exclusion criteria were: clinical or respiratory instability during the
three months before the inclusion in the study; corticosteroids therapy (> 0.5mg/kg/day of
prednisolone or as equivalent); hepatic (prothrombin time < 50%) or renal (creatininemia >
130µmol/L) failure; diabetes; left ventricular dysfunction; PSA (prostatic antigens >
2,5ng/ml) and past history or diagnosis of cancer. The study was conducted in accordance with
the Good Clinical Practices Guidelines. The study protocol was approved by the ethics review
board of the University Hospital of Bordeaux (France). Written informed consent was obtained
for all patients and investigations were conducted according to the institutional guidelines
and to the Helsinki principles. This trial conducted enrollment between 2004 and 2005, but
had not been registered in ClinicalTrials.gov because it preceded this policy.(Study design:
The dose of oral DHEA administered was 200 mg once daily for three months. At baseline and
after three months of treatment, clinical evaluation included 6MWT, Borg dyspnea index,
systolic and diastolic blood pressure, right heart catheterisation, lung function testing and
serum DHEA levels were performed.)