DHEA for Pulmonary Hypertension

(EDIPHY Trial)

Overseen By Rachel Sanders

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rhode Island Hospital

Must not be taking: Hormone supplements

Disqualifiers: HIV, Severe sleep apnea, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

24 Participants Needed

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?

Research shows that DHEA can improve heart function and reduce stress on the heart in animal models of pulmonary hypertension, and it has been shown to help with similar conditions in humans, like those related to chronic obstructive pulmonary disease (COPD). ^{1 2 3 4 5}

Is DHEA safe for humans?

DHEA, a hormone, has been studied in various trials and is generally well tolerated by humans, with ongoing research to assess its safety and effects in conditions like pulmonary hypertension. ^{1 2 3 4 6}

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. ^{1 2 3 4 6}

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

You have high blood pressure in the arteries of your lungs and high resistance in the blood vessels of your lungs.

I have been diagnosed with PAH due to genetics, a heart defect, or other specific causes.

My lung scans show moderate or less lung damage and I meet specific lung function criteria.

Exclusion Criteria

I am under 18 years old.

I started a new PAH treatment within the last 12 weeks.

I have a history of cancer in the breast, ovary, uterus, testicle, or prostate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DHEA or placebo for 18 weeks to assess effects on RV strain and other outcomes

18 weeks

Regular visits for monitoring and assessments

Crossover

Participants switch from DHEA to placebo or vice versa for another 18 weeks

18 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Final assessment visit

Treatment Details

Interventions

• DHEA
• Placebo

Trial Overview The study tests if DHEA tablets improve heart muscle function in the right ventricle compared to placebo over 18 weeks. It's a crossover trial where participants will receive both the DHEA treatment and placebo at different times to compare effects.

Participant Groups

Group I: DHEA Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

DHEA is already approved in United States, European Union, Canada for the following indications:

Approved in United States as DHEA for:

• Adrenal insufficiency
• Hypogonadism
• Menopause symptoms
• Anti-aging (off-label)
• Bodybuilding (off-label)

Approved in European Union as Prasterone for:

• Vulvar and vaginal atrophy

Approved in Canada as DHEA for:

• Adrenal insufficiency
• Hypogonadism

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

References

1. United States pubmed.ncbi.nlm.nih.gov

Experimental design of the Effects of Dehydroepiandrosterone in Pulmonary Hypertension (EDIPHY) trial. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Dehydroepiandrosterone attenuates pulmonary artery and right ventricular remodeling in a rat model of pulmonary hypertension due to left heart failure. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Dehydroepiandrosterone (DHEA) improves pulmonary hypertension in chronic obstructive pulmonary disease (COPD): a pilot study. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Beneficial effect of dehydroepiandrosterone on pulmonary hypertension in a rodent model of pulmonary hypertension in infants. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Dehydroepiandrosterone restores right ventricular structure and function in rats with severe pulmonary arterial hypertension. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Dehydroepiandrosterone sulphate reduces chronic hypoxic pulmonary hypertension in rats. [2019]