Effects of DHEA in Pulmonary Hypertension

Pulmonary Arterial Hypertension Clinical Trial

— EDIPHY  

Official title:

Effects of DHEA in Pulmonary Hypertension

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03648385
• Other study ID #: R01HL141268
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 9, 2019
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension

Intervention

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

Other:
• Placebo
1 placebo tablet taken by mouth once a day for 18 weeks

Locations

Country	Name	City	State
United States	Rhode Island Hospital Pulmonary Hypertension Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right ventricular (RV) longitudinal strain	Change in global RV longitudinal strain measured by cardiac magnetic resonance imaging (MRI) between DHEA and placebo	18 weeks, 40 weeks
Secondary	RV ejection fraction	Change in RV ejection fraction measured by cardiac MRI between DHEA and placebo	18 weeks, 40 weeks
Secondary	NT-proBNP	Change in serum level of NT-proBNP between DHEA and placebo	2 weeks, 18 weeks, 24 weeks, 40 weeks
Secondary	Sex hormone levels	Change in sex hormone levels between DHEA and placebo	2 weeks, 18 weeks, 24 weeks, 40 weeks
Secondary	Six minute walk distance (6MWD)	Change in 6MWD between DHEA and placebo	2 weeks, 18 weeks, 24 weeks, 40 weeks
Secondary	World Health Organization (WHO) Functional Class	Change in WHO Functional Class (I - IV with IV indicating worse symptoms) between DHEA and placebo	2 weeks, 18 weeks, 24 weeks, 40 weeks
Secondary	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	2 weeks, 18 weeks, 24 weeks, 40 weeks
Secondary	emPHasis-10	Change in emPHasis-10 score (range 0 - 50, higher scores indicating worse quality of life) between DHEA and placebo	2 weeks, 18 weeks, 24 weeks, 40 weeks
Secondary	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	2 weeks, 18 weeks, 24 weeks, 40 weeks, 42 weeks