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Effects of DHEA in Pulmonary Hypertension (EDIPHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648385
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: DHEA tablet Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of DHEA in Pulmonary Hypertension
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DHEA
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
 Drug: DHEA tablet
DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
Other Name: Dehydroepiandrosterone
Placebo Comparator: Placebo
1 placebo tablet taken by mouth once a day for 18 weeks
 Other: Placebo
1 placebo tablet taken by mouth once a day for 18 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Right ventricular (RV) longitudinal strain [ Time Frame: 18 weeks, 40 weeks ]
    Change in global RV longitudinal strain measured by cardiac magnetic resonance imaging (MRI) between DHEA and placebo


Secondary Outcome Measures :
  1. RV ejection fraction [ Time Frame: 18 weeks, 40 weeks ]
    Change in RV ejection fraction measured by cardiac MRI between DHEA and placebo

  2. NT-proBNP [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Change in serum level of NT-proBNP between DHEA and placebo

  3. Sex hormone levels [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Change in sex hormone levels between DHEA and placebo

  4. Six minute walk distance (6MWD) [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Change in 6MWD between DHEA and placebo

  5. World Health Organization (WHO) Functional Class [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Change in WHO Functional Class (I - IV with IV indicating worse symptoms) between DHEA and placebo

  6. Short Form-36 [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    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

  7. emPHasis-10 [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Change in emPHasis-10 score (range 0 - 50, higher scores indicating worse quality of life) between DHEA and placebo

  8. Treatment-related side effects and adverse events [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks, 42 weeks ]
    Difference in treatment-related side effects and adverse events (as assessed by CTCAE v4.0) between DHEA and placebo


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648385


Contacts
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Contact: Thomas Walsh 401-444-4833 thomas.walsh@lifespan.org
Contact: Amy Palmisciano 401-444-4961 apalmisciano@lifespan.org

Locations
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United States, Rhode Island
Rhode Island Hospital Pulmonary Hypertension Center Recruiting
Providence, Rhode Island, United States, 02903
Contact: Thomas P Walsh    401-444-4833    thomas.walsh@lifespan.org   
Contact: Amy Palmisciano, RN    4014442733    apalmisciano@lifespan.org   
Sponsors and Collaborators
Rhode Island Hospital
Investigators
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Principal Investigator: Corey E Ventetuolo, MD, MS Brown University
  Study Documents (Full-Text)

Documents provided by Rhode Island Hospital:
Informed Consent Form  [PDF] July 23, 2019

More Information
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03648385    
Other Study ID Numbers: R01HL141268 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Dehydroepiandrosterone
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs