Effects of DHEA in Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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%
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03648385
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Rhode Island Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Corey E Ventetuolo, MD, MS
Principal Investigator Affiliation Brown University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

Experimental: DHEA

DHEA tablet (50 mg) taken by mouth once a day for 18 weeks

Placebo Comparator: Placebo

1 placebo tablet taken by mouth once a day for 18 weeks

Interventions

Drug: - DHEA tablet

DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.

Other: - Placebo

1 placebo tablet taken by mouth once a day for 18 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Providence, Rhode Island

Status

Address

Rhode Island Hospital Pulmonary Hypertension Center

Providence, Rhode Island, 02903

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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