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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

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 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

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

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor
263 Previous Clinical Trials
68,555 Total Patients Enrolled
2 Trials studying Pulmonary Arterial Hypertension
85 Patients Enrolled for Pulmonary Arterial Hypertension
Corey E Ventetuolo, MD, MSPrincipal InvestigatorBrown University
~0 spots leftby Dec 2024
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