Dapagliflozin (DAPA) Effects in HFpEF

Mayo Clinic

Status and phase

Completed

Phase 2

Conditions

Heart Failure With Preserved Ejection Fraction

Treatments

Drug: Placebo

Drug: Dapagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT04730947

20-005646

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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,