Study to Evaluate the Safety and Effectiveness of IW-1973 Dosing over 12 Weeks in Patients with Congestive Heart Failure with Preserved Ejection Fraction

Overview

About this study

The purpose of this 12 week study is to assess the safety of oral IW-1973 when administered to patients with heart failure with preserved ejection fraction (HFpEF) and its effect on peak exercise capacity, both in all patients and in patients without permanent or persistent atrial fibrillation

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient is an ambulatory male or female ≥45 years old at the screening visit.
  • Patient has heart failure with ejection fraction (EF) of ≥40%.
  • Patient has a peak VO2 measuring <80% of age- and sex-adjusted normal values.
  • Patient has evidence in medical history supporting clinical heart failure syndrome consisting of at least 1 of the following:
    • Hospitalization or emergency department visit for heart failure within the past year;
    • Elevated B-type natriuretic peptide (BNP) or N-terminal pro b-type natriuretic peptide (NT-proBNP) within the past 6 months;
    • 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;
    • Hemodynamic evidence of elevated filling pressures.
  • Patient meets at least 2 of the following criteria at the screening visit:
    • Diagnosis of type 2 diabetes mellitus or prediabetes;
    • History of hypertension;
    • Body mass index (BMI) >30 kg/m2;
    • Age ≥70 years.

Exclusion Criteria:

  • Patient has had acute coronary syndrome or percutaneous coronary intervention within 30 days before randomization.
  • Patient has had cardiac transplantation or has cardiac transplantation planned during the study.
  • 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.
  • Patient has severe chronic obstructive coronary disease as defined by chronic oxygen dependence.
  • Patient had had heart failure hospitalization with discharge within 30 days before the screening visit.
  • Patient has a history of clinically significant hypersensitivity or allergies to any of the inactive ingredients contained in the active or placebo drug products.
  • 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.
  • 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.
  • Patient is taking strong cytochrome P450 3A (CYP3A) inhibitors.
  • 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.
  • 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.
  • Other exclusion criteria per protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Bruce Johnson, Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20441691

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