DHEA for Pulmonary Hypertension
(EDIPHY Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot start new PAH therapy or change the dose significantly within 12 weeks before the trial. Also, you cannot use hormone supplements or certain hormonal therapies.
What evidence supports the effectiveness of the drug DHEA for treating pulmonary hypertension?
Is DHEA safe for humans?
How does the drug DHEA differ from other treatments for pulmonary hypertension?
DHEA is unique because it directly targets the heart's right ventricle function and influences nitric oxide and endothelin-1 signaling, which are not directly addressed by other treatments. It also acts as an activator of calcium-gated potassium channels, which helps reduce pulmonary hypertension by affecting blood vessel function.12346
What is the purpose of this trial?
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.
Research Team
Corey E Ventetuolo, MD, MS
Principal Investigator
Brown University
Eligibility Criteria
This trial is for adults with pulmonary arterial hypertension, a type of high blood pressure affecting the lungs. Participants must have specific heart and lung function test results and can't be pregnant or breastfeeding, have certain cancers, severe kidney or liver disease, untreated thyroid issues, or use hormone therapies.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either DHEA or placebo for 18 weeks to assess effects on RV strain and other outcomes
Crossover
Participants switch from DHEA to placebo or vice versa for another 18 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- DHEA
- Placebo
DHEA is already approved in United States, European Union, Canada for the following indications:
- Adrenal insufficiency
- Hypogonadism
- Menopause symptoms
- Anti-aging (off-label)
- Bodybuilding (off-label)
- Vulvar and vaginal atrophy
- Adrenal insufficiency
- Hypogonadism
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rhode Island Hospital
Lead Sponsor