Effects of DHEA in Pulmonary Hypertension (EDIPHY)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03648385 |
Recruitment Status :
Recruiting
First Posted : August 27, 2018
Last Update Posted : March 29, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Arterial Hypertension | Drug: DHEA tablet Other: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of DHEA in Pulmonary Hypertension |
Actual Study Start Date : | January 9, 2019 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | April 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: DHEA
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
|
Drug: DHEA tablet
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
Other Name: Dehydroepiandrosterone |
Placebo Comparator: Placebo
1 placebo tablet taken by mouth once a day for 18 weeks
|
Other: Placebo
1 placebo tablet taken by mouth once a day for 18 weeks |
- Right ventricular (RV) longitudinal strain [ Time Frame: 18 weeks, 40 weeks ]Change in global RV longitudinal strain measured by cardiac magnetic resonance imaging (MRI) between DHEA and placebo
- RV ejection fraction [ Time Frame: 18 weeks, 40 weeks ]Change in RV ejection fraction measured by cardiac MRI between DHEA and placebo
- NT-proBNP [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]Change in serum level of NT-proBNP between DHEA and placebo
- Sex hormone levels [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]Change in sex hormone levels between DHEA and placebo
- Six minute walk distance (6MWD) [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]Change in 6MWD between DHEA and placebo
- World Health Organization (WHO) Functional Class [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]Change in WHO Functional Class (I - IV with IV indicating worse symptoms) between DHEA and placebo
- Short Form-36 [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]Change in Short Form-36 summary scores for physical and mental components (range 0 - 100, higher scores indicating better quality of life) between DHEA and placebo
- emPHasis-10 [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]Change in emPHasis-10 score (range 0 - 50, higher scores indicating worse quality of life) between DHEA and placebo
- Treatment-related side effects and adverse events [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks, 42 weeks ]Difference in treatment-related side effects and adverse events (as assessed by CTCAE v4.0) between DHEA and placebo

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648385
Contact: Thomas Walsh | 401-444-4833 | thomas.walsh@lifespan.org | |
Contact: Ryan DiGregorio | 401-444-2733 | rdigregorio@lifespan.org |
United States, Rhode Island | |
Rhode Island Hospital Pulmonary Hypertension Center | Recruiting |
Providence, Rhode Island, United States, 02903 | |
Contact: Thomas P Walsh 401-444-4833 thomas.walsh@lifespan.org | |
Contact: Amy Palmisciano, RN 4014442733 apalmisciano@lifespan.org |
Principal Investigator: | Corey E Ventetuolo, MD, MS | Brown University |
Responsible Party: | Rhode Island Hospital |
ClinicalTrials.gov Identifier: | NCT03648385 |
Other Study ID Numbers: |
R01HL141268 ( U.S. NIH Grant/Contract ) |
First Posted: | August 27, 2018 Key Record Dates |
Last Update Posted: | March 29, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension, Pulmonary Pulmonary Arterial Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Dehydroepiandrosterone Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |