Dapagliflozin (DAPA) Effects in HFpEF

Evaluation of the Cardiac and Metabolic Effects of Dapagliflozin in Heart Failure With Preserved Ejection Fraction (CAMEO-DAPA): A Phase II, Prospective, Double-Blind Study

The purpose of this study is to determine whether treatment with Dapagliflozin (DAPA) for 6 months will improve pulmonary capillary wedge pressure (PCWP) during exercise in heart failure/preserved ejection fraction (HFpEF) and improve cardiac metabolism.

Inclusion Criteria:

• Signed informed consent prior to any study specific procedures.
• Male or female.
• Symptoms of dyspnea (NYHA II-III) with no non-cardiac or ischemia explanation.
• EF ≥ 50% + BMI ≥ 30 kg/m^2
• Elevated pulmonary capillary wedge pressure (PCWP) during exercise (≥ 25 mmHg) ascertained at Visit 1. Patients that have consented to study procedures but do not meet this invasive criterion will be considered as screen failures and will not be randomized .

Exclusion Criteria:

• Type I diabetes.
• Type II diabetes with poor control (HgbA1C ≥ 10%).
• Recent hospitalization (< 30 days) or revascularization (< 90 days).
• Primary cardiomyopathy (such as amyloid).
• Constrictive pericarditis.
• Dyspnea due to primary lung disease or myocardial ischemia in the opinion of the investigator.
• Severe anemia (hemoglobin < 9gm/dl.
• Significant left-sided valvular heart disease (> mild stenosis, > moderate regurgitation),
• Severe kidney disease (estimated glomerular filtration rate (GFR) < 30) or liver disease,