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TDE-HF-301


Title TDE-HF-301: 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) 
Therapeutic Area Pulmonary Hypertension
Principal Investigator Ioana Preston, MD
Min Age 18 Years
Max Age 85 Years
Gender All
Contact Karen Visnaw, RN
617 636 1334
More Information https://www.clinicaltrials.gov/ct2/show/NCT3043651

Overview

A multicenter, randomized, double-blind, placebo-controlled, 24-week, parallel-group study. Approximately 310 subjects will be enrolled and randomly allocated (1:1) to receive oral treprostinil or placebo, stratified by Baseline 6MWD. The primary objective of this study is to assess the effect of oral treprostinil compared with placebo on change in exercise capacity as measured by change in 6-Minute Walk Distance (6MWD) from Baseline to Week 24 in subjects with PH associated with HFpEF. The secondary objective of this study is to assess the effect of oral treprostinil compared with placebo on the following: Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from Baseline to Week 24 Time to clinical worsening where clinical worsening is defined by at least 1 
of the following: oospitalization due to a cardiopulmonary indication, Outpatient administration of 1 intravenous (IV) diuretics, Decrease in 6MWD > 15% from Baseline (or too ill to walk) directly related 
to disease under study, at 2 consecutive visits on different days, or Death (all causes) Change in World Health Organization (WHO) Functional Class from Baseline to Week 24.

Study Details

Inclusion Criteria

  • The subject voluntarily gives informed consent to participate in the study

Exclusion Criteria

  • The subject is pregnant or lactating

Study Requirements

  • Your vital signs will be collected (weight, blood pressure, breathing and heart rate, and the amount of oxygen in your blood
  • If you are using oxygen, the amount of oxygen you are using will be collected
  • An electrocardiogram (ECG) will be performed to measure your heart's electrical activity
  • About 3-4 teaspoons of blood will be drawn for routine clinical laboratory tests and an NT-pro­-BNP
  • About 4 teaspoons of blood will be drawn if you agreed to participate in the Optional Biomarker and Pharmacogenomic Sequencing Testing
  • A urine sample will be collected if you agreed to participate in the Optional Biomarker Testing
  • A urine pregnancy test will be performed if you are a woman of childbearing potential
  • Measurement of your exercise capacity (6 Minute Walk Test)
  • An Echocardiogram (if not done during your screening visit)
  • Your current medications and current illnesses will be reviewed