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Could a natural hormone help hearts in pulmonary hypertension?

NCT ID NCT03648385

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

26 people

The number who actually took part.

Started

Jan 2019

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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