Effects of DHEA in Pulmonary Hypertension

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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 compared to placebo and to assess side effects and safety in pulmonary arterial hypertension.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rhode Island Hospital
• Treatments: Dehydroepiandrosterone

Criteria

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%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