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NCT Number: NCT01273259

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Cardiovascular Diseases Chronic Disease Disease Attributes Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital, Bordeaux, Bordeaux, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHEA Treatment

Drug

DHEA : 200 mg/day hard gelatine capsule

Primary outcomes

Efficacy of DHEA on exercise capacity (six-minute walk test)

Time frame: inclusion and one year of treatment

Secondary outcomes

Pulmonary and systemic arterial pressures (mean, systolic and diastolic)

Time frame: Inclusion and after one year of treatment
Pulmonary vascular resistances

Time frame: Inclusion and after one year of treatment
Safety / Compliance

Time frame: along one year of treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: Dromer

Important dates

Study start: 2008
Primary completion: 2015
Study completion: 2015
First posted: Jan 10, 2011
Registry last updated: Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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