Could a natural hormone help hearts in pulmonary hypertension?
NCT ID NCT03648385
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether DHEA, a natural hormone, can improve heart function in people with pulmonary arterial hypertension (high blood pressure in the lungs). 26 adults took DHEA or a placebo for 18 weeks, then switched. The main goal was to see changes in heart strain measured by MRI. The study also checked safety and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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26 people
The number who actually took part.
- Started
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Jan 2019
- Finished
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Dec 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Exclusion Criteria: * Age \< 18 years old * PAH associated with human immunodeficiency virus infection * New background PAH therapy within 12 weeks * Significant dose change in background PAH therapy within 12 weeks. * Untreated severe obstructive sleep apnea diagnosed by polysomnography * Evidence of left-sided valvular disease or systolic dysfunction on echocardiogram (≥ moderate mitral or aortic disease or LV ejection fraction ≤ 50%) * Glomerular filtration rate \<40 mls/min/1.73m2 * Child-Pugh Class C cirrhosis * Untreated hypo- or hyper-thyroidism * Pregnant or breastfeeding * Active or planned use of hormone supplements, oral contraceptive pills, hormonal therapies * History of breast, ovarian, uterine, testicular or prostate cancer * Current use of another investigational PAH therapy * Contraindication to MRI (e.g., metal device or fragment) * History of significant non-adherence or circumstance which would threaten ability to comply with cross-over design and study visit schedule
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Rhode Island Hospital Pulmonary Hypertension Center
Providence, Rhode Island, 02903, United States
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