Dapagliflozin (DAPA) Effects in HFpEF

• Status: Recruiting
• Trial end date: 2023-07-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

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 revasculariation (< 90 days).

• Primary cardiomyopathy (such as amyloid).

• Constrictive pericarditis.

• Dyspea due to primary lung disease or myoardial 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 GFR < 30) or liver disease,