NCT03648385CompletedPhase 2
Effects of DHEA in Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 5 Nov 2025
Brief summary (registry, in English)
The goal of this crossover trial is to determine whether the study drug dehydroepiandrosterone (DHEA) improves right ventricular longitudinal strain measured by cardiac magnetic resonance imaging at 18 weeks AND 40 weeks compared to placebo and to assess side effects and safety in pulmonary arterial hypertension.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 10 Aug 2018
- Start date
- 9 Jan 2019
- Primary completion date
- 24 Jun 2024
- Lead sponsor
- Rhode Island Hospital
- NCT number
- NCT03648385
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 26
- From 9 Jan 2019 to the primary completion date, 24 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- New background PAH therapy within 12 weeks
- Significant dose change in background PAH therapy within 12 weeks.
- Active or planned use of hormone supplements, oral contraceptive pills, hormonal therapies
- Current use of another investigational PAH therapy
Other illness
- PAH associated with human immunodeficiency virus infection
- History of breast, ovarian, uterine, testicular or prostate cancer
- History of significant non-adherence or circumstance which would threaten ability to comply with cross-over design and study visit schedule
Lab values
- Evidence of left-sided valvular disease or systolic dysfunction on echocardiogram (≥ moderate mitral or aortic disease or LV ejection fraction ≤ 50%)
Age
- Age \< 18 years old
Other
- Untreated severe obstructive sleep apnea diagnosed by polysomnography
- Glomerular filtration rate \<40 mls/min/1.73m2
- Child-Pugh Class C cirrhosis
- Untreated hypo- or hyper-thyroidism
- Pregnant or breastfeeding
- Contraindication to MRI (e.g., metal device or fragment)
Who the study is looking for
- Diagnosis of PAH that is 1) idiopathic, 2) heritable or 3) associated with connective tissue disease, congenital systemic-to-pulmonary shunt, porto-pulmonary hypertension, drug or toxin use.
- Documentation of the following at any time prior to study entry:
- mPAP ≥ 25 mmHg at rest, pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg, and PVR \> 3 Wood units
- Pulmonary function testing documenting forced expiratory volume in one second/forced vital capacity ratio ≥ 70% predicted and total lung capacity ≥ 70% predicted
- If TLC is mildly reduced (60%\<TLC%\<70%), computerized tomography (HRCT or non-HRCT) documenting no significant interstitial lung disease may be used to fulfill this requirement.
- Chest tomography documenting no more than moderate parenchymal lung disease with clinician designated WHO I PAH and meeting both TLC and FEV1/FVC criteria.
- Normal or low probability V/Q scan
- If no V/Q scan is available, a CT angiogram documenting the absence of thromboembolic disease may be used, provided the subject meets diagnostic PAH criteria
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rhode Island Hospital Pulmonary Hypertension Center Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.