Purpose

The objective of the CAPACITY-HFpEF study is to evaluate the safety and efficacy of IW-1973 compared with placebo when administered daily for approximately 12 weeks to patients with HFpEF. The study will evaluate the effect of oral IW-1973 on peak exercise capacity in patients with HFpEF, with or without permanent or persistent atrial fibrillation.

Condition

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Patient is an ambulatory male or female ≥45 years old at the Screening Visit
  2. Patient has heart failure with ejection fraction (EF) of ≥40%
  3. Patient has a peak VO2 measuring <80% of age- and sex-adjusted normal values
  4. Patient has evidence in medical history supporting clinical heart failure syndrome consisting of at least 1 of the following:
  5. Hospitalization or emergency department visit for heart failure within the past year
  6. Elevated B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) within the past 6 months
  7. Echocardiographic evidence within the past 12 months of at least 2 of the following: left ventricular (LV) hypertrophy, left atrial (LA) enlargement, or diastolic dysfunction
  8. Hemodynamic evidence of elevated filling pressures
  9. Patient meets at least 2 of the following criteria at the Screening Visit:
  10. Diagnosis of type 2 diabetes mellitus or prediabetes
  11. History of hypertension
  12. Body mass index (BMI) >30 kg/m2
  13. Age ≥70 years

Exclusion Criteria

  1. Patient has had acute coronary syndrome or percutaneous coronary intervention within 30 days before Randomization
  2. Patient has had cardiac transplantation or has cardiac transplantation planned during the study
  3. Patient has had cardiac artery bypass graft, cardiac mechanical support implantation, or other cardiac surgery in the 3 months before the Screening Visit or planned during the study
  4. Patient has severe chronic obstructive coronary disease as defined by chronic oxygen dependence
  5. Patient had had heart failure hospitalization with discharge within 30 days before the Screening Visit
  6. Patient has a history of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products
  7. Patient has previously received IW-1973 in a study, or received an investigational drug during the 30 days or 5 half lives of that investigational drug (whichever is longer) before the Screening Visit, or is planning to receive another investigational drug at any time during the study
  8. Patient is taking specific inhibitors of phosphodiesterase 5 (PDE5), nonspecific inhibitors of PDE5, any supplements for the treatment of erectile dysfunction, riociguat, or nitrates or nitric oxide (NO) donors in any form
  9. Patient is taking strong cytochrome P450 3A (CYP3A) inhibitors
  10. Women of childbearing potential must have a negative pregnancy test prior to randomization and must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug
  11. Male patients must be surgically sterile by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) or must agree to use protocol-specified contraception from the Screening Visit through 60 days after the final dose of study drug
  12. Other exclusion criteria per protocol

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IW-1973 High Dose
  • Drug: IW-1973
    Oral Tablet
Placebo Comparator
Placebo
Placebo to match experimental drug
  • Drug: Placebo Oral Tablet
    Oral Tablet

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

NCT ID
NCT03254485
Status
Recruiting
Sponsor
Ironwood Pharmaceuticals, Inc.

Study Contact

Stella Ibebunjo, PhD
617-621-8302
sibebunjo@ironwoodpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.