Overview
The purpose of this study is to learn about the safety and effects of the study medicine (PF-07328948) for the possible treatment of heart failure (HF).
Description
All participants in this study will take either the study medicine (PF-07328948) tablets, or placebo tablets, once daily, by mouth, every day for 36 weeks. The study determines if the study medicine (PF-07328948) is safe and effective compared to placebo in people with heart failure who are already taking standard-of-care medications for heart failure that include sodium-glucose cotransporter 2 (SGLT2) inhibitors. Participants will be involved in this study for about 48 weeks. During this time, participants will visit the study clinic 15 times. In general, 5 of these visits may be performed at home by phone and the other 10 visits will take place at the study site.
Eligibility
This study is seeking participants who are:
Key Inclusion Criteria include:
- aged 18 years or older.
- - clinically confirmed to have a diagnosis of heart failure for at least 3 months
- New York Heart Association Class II-IV symptoms
- left ventricular ejection fraction greater than 40%
- Body mass index of 27 kg/m2 or higher
- Kansas City Cardiomyopathy Questionnaire-23 Total Symptom Score < 85
- Six-minute walking distance greater than 75 meters
Key Exclusion Criteria include:
- Type 1 diabetes mellitus, liver cirrhosis or any condition that can possibly affect how the medicine is absorbed into the body.
- Major surgery scheduled for the duration of the study, affecting walking ability in the opinion of the study doctor.
- History of heart transplantation, or currently listed for a heart transplant, or current planned use of IV vasodilators and/ or inotropes
- Prior intolerance/known hypersensitivity to an SGLT2 inhibitor or contraindication to an SGLT2 inhibitor