Summary

for people ages 18-85 (full criteria)
at UCLA UC Davis
study started
estimated completion:
Rajan Saggar (ucla) Roblee Allen (ucdavis)

Description

Summary

This is a multicenter, randomized (1:1; oral treprostinil to placebo), double-blind, placebo-controlled study in subjects with World Health Organization (WHO) Group 2 pulmonary hypertension (PH) associated with heart failure with preserved ejection fraction (HFpEF). Once randomized, subjects will take the initial dose of study drug at the study site on the day of randomization. Subjects will return to the study site for visits scheduled at Weeks 6, 12, 18, and 24. The treatment phase of the study will last approximately 24 weeks.

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension (PH) in Heart Failure With Preserved Ejection Fraction (HFpEF)

Keywords

Pulmonary Hypertension Heart Failure With a Preserved Ejection Fraction 6-Minute Walk Test HFpEF Oral Treprostinil Hypertension Heart Failure Hypertension, Pulmonary Treprostinil

Eligibility

You can join if…

Open to people ages 18-85

  1. The subject has undergone a right heart catheterization (RHC) within 120 days of Baseline.
  2. The subject has a diagnosis of heart failure with a left ventricular ejection fraction(LVEF) ≥45% by echocardiogram (ECHO) completed prior to randomization.
  3. The subject's baseline 6MWD must be at least 150 meters.
  4. The subject has pulmonary function tests conducted within 6 months of Screening or during the Screening phase.
  5. Subjects on a chronic medication for heart failure must be on a stable dose for ≥30 days prior to randomization.
  6. Subjects on chronic medications for any underlying respiratory condition must be on a stable dose for ≥30 days prior to randomization.

You CAN'T join if...

  1. The subject is pregnant or lactating.
  2. In the opinion of the Principal Investigator, the subject has a primary diagnosis of PH other than WHO Group 2 PH.
  3. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation of therapy or inability to effectively titrate that therapy.
  4. The subject has received any approved PAH therapy within 30 days of randomization.
  5. The subject has been hospitalized for a cardiopulmonary indication within 30 days of randomization.
  6. The subject had a myocardial infarction within 90 days of randomization.
  7. The subject had cardiac resynchronization therapy within 90 days of randomization or anticipated resynchronization therapy during the study treatment period.
  8. The subject has liver function tests greater than 3 times the upper limit of normal at Screening, clinically significant liver disease/dysfunction, known Child-Pugh Class C hepatic disease, or noncirrhotic portal hypertension.
  9. The subject has uncontrolled systemic hypertension, systolic blood pressure <100 mmHg,or a resting heart rate >100 beats per minute at Baseline.
  10. . The subject has known genetic hypertrophic cardiomyopathy, sarcoidosis, or cardiac amyloidosis.
  11. . The subject has a known history of any LVEF less than 40% by ECHO within 3 years of randomization.
  12. . The subject has hemodynamically significant valvular heart disease as determined by the Investigator, including: greater than mild aortic and/or mitral stenosis or severe mitral and/or aortic regurgitation (>Grade 3)
  13. . The subject has a Body Mass Index >45 kg/m2.

  14. . The subject has any musculoskeletal disorder, or has any other condition that limits ambulation.
  15. . The subject has end-stage renal disease requiring/receiving dialysis.
  16. . The subject participated in an investigational drug or device study within 30 days prior to signing consent.

Locations

  • University of California Los Angeles Pulmonary Division accepting new patients
    Los Angeles California 90095 United States
  • University of California - Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • VA Healthcare System of Greater Los Angeles accepting new patients
    Los Angeles California 90073 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90211 United States

Lead Scientists

  • Rajan Saggar (ucla)
    Assistant Professor, Medicine. Authored (or co-authored) 70 research publications
  • Roblee Allen (ucdavis)
    Professor, Pulmonary, Critical Care, and Sleep Medicine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT03037580
Phase
Phase 3
Study Type
Interventional
Last Updated