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CAPACITY HFpEF


Title A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Safety and Efficacy of Different Doses of IW-1973 over 12 Weeks in Patients with Heart Failure with Preserved Ejection Fraction (CAPACITY HFpEF)
Therapeutic Area Heart Failure
Principal Investigator James Udelson, MD
Min Age 50 Years
Gender Any
Contact Corinne Pellows
617-636-4884
More Information https://www.clinicaltrials.gov/ct2/show/NCT03254485

Overview

This study will evaluate the safety and efficacy of 3 doses of IW-1973 compared with placebo, a drug that looks like the study drug but has none of the active ingredients. During the study participants will be asked to take the drug daily for about 12 weeks, 2 weeks of taking the drug twice-daily followed by 10 weeks of taking the drug once-daily. At the Day 1 Visit, patients will spend about 2 hours going through study required assessments to help determine if they qualify for the study. Once those assessments are finished patients will be randomized, randomly assigned to one of the groups: 10mg study drug, 20mg study drug, 40mg study drug, or placebo daily. After Visit 1 participants will be asked to return to the clinical at Week 4, Week 8, and End of Treatment for study drug administration; safety efficacy, and a few additional assessments; and to receive additional study drug and other supplies, as applicable. Patients will return to the clinic 28 days (day 113+/-7) after their last study drug dose for the final Follow-up Visit. 

Study Details

Inclusion Criteria

  • Patient is able to walk around, male or female >50 years old, at the Screening Visit
  • Patient who have a Left Ventricular Ejection Fraction (obtained by an echocardiography) >45
  • Patient meets at least 2 of the following criteria at the Screening Visit:
    1. Diagnosis of type 2 diabetes mellitus or prediabetes
    2. History of hypertension
    3. Body mass index (BMI) >30kg/m2
    4. Age >70 years

Exclusion Criteria

  • Patient has severe chronic obstructive coronary disease as defined by chronic oxygen dependence.
  • Patients who have had cardiac transplantation or has cardiac transplantation planned during the study.
  • Patient has had acute coronary syndrome or precutaneous coronary intervention within 30 days before randomization.

Study Requirements

The study will be dived into 3 periods: Screening, Treatment, and Follow-up. There are 8 visits in total, Visit 1, Visit 2, Visit 5, Visit 6, and Visit 8 will take about 2 hours, and the other 3 visits will be about 8 hours. During these visits you may be asked to do some or all of the following:

  • A Physical exam, review of medical history
  • A blood sample
  • A urine sample
  • An electrogardiogram (ECG)
  • A echocardiogram (ECHO)
  • A Cardiopulmonary Exercise Test (CPET)
  • Receive / Return Study Drug
  • Questionnaires about how you are feeling
  • A 6 Minute Walk Test