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Effects of DHEA in Pulmonary Hypertension (EDIPHY)

Primary Purpose

Pulmonary Arterial Hypertension

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

DHEA tablet

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of PAH that is 1) idiopathic, 2) heritable or 3) associated with connective tissue disease, congenital systemic-to-pulmonary shunt, porto-pulmonary hypertension, drug or toxin use.

Documentation of the following at any time prior to study entry:

mPAP ≥ 25 mmHg at rest, pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mmHg, and PVR > 3 Wood units
Pulmonary function testing documenting forced expiratory volume in one second/forced vital capacity ratio ≥ 70% predicted and total lung capacity ≥ 70% predicted
If TLC is mildly reduced (60%<TLC%<70%), computerized tomography (HRCT or non-HRCT) documenting no significant interstitial lung disease may be used to fulfill this requirement.
Chest tomography documenting no more than moderate parenchymal lung disease with clinician designated WHO I PAH and meeting both TLC and FEV1/FVC criteria.
Normal or low probability V/Q scan
If no V/Q scan is available, a CT angiogram documenting the absence of thromboembolic disease may be used, provided the subject meets diagnostic PAH criteria

Exclusion Criteria:

Age < 18 years old
PAH associated with human immunodeficiency virus infection
New background PAH therapy within 12 weeks
Significant dose change in background PAH therapy within 12 weeks.
Untreated severe obstructive sleep apnea diagnosed by polysomnography
Evidence of left-sided valvular disease or systolic dysfunction on echocardiogram (≥ moderate mitral or aortic disease or LV ejection fraction ≤ 50%)
Glomerular filtration rate <40 mls/min/1.73m2
Child-Pugh Class C cirrhosis
Untreated hypo- or hyper-thyroidism
Pregnant or breastfeeding
Active or planned use of hormone supplements, oral contraceptive pills, hormonal therapies
History of breast, ovarian, uterine, testicular or prostate cancer
Current use of another investigational PAH therapy
Contraindication to MRI (e.g., metal device or fragment)
History of significant non-adherence or circumstance which would threaten ability to comply with cross-over design and study visit schedule

Sites / Locations

Rhode Island Hospital Pulmonary Hypertension CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DHEA

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Right ventricular (RV) longitudinal strain

Change in global RV longitudinal strain measured by cardiac magnetic resonance imaging (MRI) between DHEA and placebo

Secondary Outcome Measures

RV ejection fraction

Change in RV ejection fraction measured by cardiac MRI between DHEA and placebo

NT-proBNP

Change in serum level of NT-proBNP between DHEA and placebo

Sex hormone levels

Change in sex hormone levels between DHEA and placebo

Six minute walk distance (6MWD)

Change in 6MWD between DHEA and placebo

World Health Organization (WHO) Functional Class

Change in WHO Functional Class (I - IV with IV indicating worse symptoms) between DHEA and placebo

Short Form-36

Change in Short Form-36 summary scores for physical and mental components (range 0 - 100, higher scores indicating better quality of life) between DHEA and placebo

emPHasis-10

Change in emPHasis-10 score (range 0 - 50, higher scores indicating worse quality of life) between DHEA and placebo

Treatment-related side effects and adverse events

Difference in treatment-related side effects and adverse events (as assessed by CTCAE v4.0) between DHEA and placebo

Full Information

NCT ID

NCT03648385

First Posted

August 10, 2018

Last Updated

February 17, 2023

Sponsor

Rhode Island Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03648385

Brief Title

Effects of DHEA in Pulmonary Hypertension

Acronym

EDIPHY

Official Title

Effects of DHEA in Pulmonary Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 9, 2019 (Actual)

Primary Completion Date

April 2023 (Anticipated)

Study Completion Date

April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DHEA

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

DHEA tablet

Other Intervention Name(s)

Dehydroepiandrosterone

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Right ventricular (RV) longitudinal strain

Description

Change in global RV longitudinal strain measured by cardiac magnetic resonance imaging (MRI) between DHEA and placebo

Time Frame

18 weeks, 40 weeks

Secondary Outcome Measure Information:

Title

RV ejection fraction

Description

Change in RV ejection fraction measured by cardiac MRI between DHEA and placebo

Time Frame

18 weeks, 40 weeks

Title

NT-proBNP

Description

Change in serum level of NT-proBNP between DHEA and placebo

Time Frame