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Androgen

DHEA for Pulmonary Hypertension (EDIPHY Trial)

Phase 2

Waitlist Available

Led By Corey E Ventetuolo, MD, MS

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of PAH that is idiopathic, heritable, or associated with connective tissue disease, congenital systemic-to-pulmonary shunt, porto-pulmonary hypertension, drug or toxin use

Chest tomography documenting no more than moderate parenchymal lung disease with clinician designated WHO I PAH and meeting both TLC and FEV1/FVC criteria

Must not have

Age < 18 years old

History of breast, ovarian, uterine, testicular or prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 18 weeks, 24 weeks, 40 weeks, 42 weeks

Awards & highlights

Summary

This trial is testing whether a drug called DHEA can help improve heart function in people with pulmonary arterial hypertension.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, potential side effects of DHEA may include oily skin, acne, hair loss, stomach upset, high blood pressure changes in menstrual cycle for women and possibly others as determined during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My lung function tests show normal breathing and capacity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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

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My kidney function is reduced.

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I have untreated thyroid issues.

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I have severe sleep apnea that hasn't been treated.

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My liver disease is severe.

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My heart's left side has a moderate to severe valve problem or its pumping ability is reduced.

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I have pulmonary arterial hypertension related to HIV.

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I am currently using or plan to use hormone supplements or therapies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 18 weeks, 24 weeks, 40 weeks, 42 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 18 weeks, 24 weeks, 40 weeks, 42 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 18 weeks, 24 weeks, 40 weeks, 42 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Right ventricular (RV) longitudinal strain

Secondary study objectives

NT-proBNP

RV ejection fraction

Sex hormone levels

+5 more

Side effects data

From 2015 Phase 3 trial • 558 Patients • NCT02013544

Application site discharge

100%

80%

60%

40%

20%

Study treatment Arm

0.50% Prasterone (DHEA)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DHEAExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

262 Previous Clinical Trials

68,915 Total Patients Enrolled

2 Trials studying Pulmonary Arterial Hypertension

85 Patients Enrolled for Pulmonary Arterial Hypertension

Corey E Ventetuolo, MD, MSPrincipal InvestigatorBrown University

~1 spots leftby Dec 2024

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