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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

EDIPHY Trial 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.Check my eligibility

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.See study design

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.

EDIPHY 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.

EDIPHY Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Right ventricular (RV) longitudinal strain

Secondary outcome measures

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

EDIPHY 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rhode Island HospitalLead Sponsor

260 Previous Clinical Trials

71,710 Total Patients Enrolled

2 Trials studying Pulmonary Arterial Hypertension

85 Patients Enrolled for Pulmonary Arterial Hypertension

Corey E Ventetuolo, MD, MSPrincipal InvestigatorBrown University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does ingesting a DHEA tablet pose any considerable risks to health?

"As Phase 2 trials provide some evidence of safety but none regarding efficacy, Power's team assigned a score of 2 to the DHEA tablet."

Answered by AI

What is the upper limit of participants for this research endeavor?

"Yes, per the data available on clinicaltrials.gov this experiment is actively enrolling participants. This trial was first posted in September 1st of 2019 and its most recent update occurred on March 25th 2022. The researchers need to recruit 24 patients from a single medical centre."

Answered by AI

Have there been any other investigations involving DHEA supplementation?

"Currently, 5 clinical trials are running to assess the effectiveness of DHEA tablet. Of these, 2 have progressed to Phase 3 while the remainder remain in earlier stages. The majority of sites conducting this research are located around Providence, Rhode island with a total of 6 medical centres involved."

Answered by AI

Are there openings available for interested participants in this clinical trial?

"Clinicaltrials.gov states that this medical experiment is actively recruiting test subjects, having been originally posted on September 1st 2019 and edited as recently as March 25th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of DHEA in Pulmonary Hypertension

2019. "Effects of DHEA in Pulmonary Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03648385.

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