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Effects of DHEA in Pulmonary Hypertension (EDIPHY)

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ClinicalTrials.gov Identifier: NCT03648385
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Rhode Island Hospital

Tracking Information
First Submitted Date  ICMJE August 10, 2018
First Posted Date  ICMJE August 27, 2018
Last Update Posted Date March 29, 2022
Actual Study Start Date  ICMJE January 9, 2019
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
Right ventricular (RV) longitudinal strain [ Time Frame: 18 weeks, 40 weeks ]
Difference in global RV longitudinal strain measured by cardiac magnetic resonance imaging (MRI) between DHEA and placebo
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2018)
  • RV ejection fraction [ Time Frame: 18 weeks, 40 weeks ]
    Change in RV ejection fraction measured by cardiac MRI between DHEA and placebo
  • NT-proBNP [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Change in serum level of NT-proBNP between DHEA and placebo
  • Sex hormone levels [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Change in sex hormone levels between DHEA and placebo
  • Six minute walk distance (6MWD) [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Change in 6MWD between DHEA and placebo
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • RV ejection fraction [ Time Frame: 18 weeks, 40 weeks ]
    Difference in RV ejection fraction measured by cardiac MRI between DHEA and placebo
  • NT-proBNP [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Difference in serum level of NT-proBNP between DHEA and placebo
  • Sex hormone levels [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Difference in sex hormone levels between DHEA and placebo
  • Six minute walk distance (6MWD) [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Difference in 6MWD between DHEA and placebo
  • World Health Organization (WHO) Functional Class [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Difference in WHO Functional Class (I - IV with IV indicating worse symptoms) between DHEA and placebo
  • Short Form-36 [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Difference 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 [ Time Frame: 2 weeks, 18 weeks, 24 weeks, 40 weeks ]
    Difference 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 [ 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of DHEA in Pulmonary Hypertension
Official Title  ICMJE Effects of DHEA in Pulmonary Hypertension
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Arterial Hypertension
Intervention  ICMJE
  • Drug: DHEA tablet
    DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
    Other Name: Dehydroepiandrosterone
  • Other: Placebo
    1 placebo tablet taken by mouth once a day for 18 weeks
Study Arms  ICMJE
  • Experimental: DHEA
    DHEA tablet (50 mg) taken by mouth once a day for 18 weeks
    Intervention: Drug: DHEA tablet
  • Placebo Comparator: Placebo
    1 placebo tablet taken by mouth once a day for 18 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Walsh 401-444-4833 thomas.walsh@lifespan.org
Contact: Ryan DiGregorio 401-444-2733 rdigregorio@lifespan.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03648385
Other Study ID Numbers  ICMJE R01HL141268( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rhode Island Hospital
Study Sponsor  ICMJE Rhode Island Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Corey E Ventetuolo, MD, MS Brown University
PRS Account Rhode Island Hospital
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP