Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors generally and empagliflozin specifically have shown cardiovascular benefits in patients with heart failure (HF), but the underlying mechanisms remain unclear. Empagliflozin use resulted in lower pulmonary artery diastolic pressures in patients with HF, suggesting a beneficial diuretic effect. Other potential mechanisms include increased blood volume, decreased blood pressure, and changes in sympathetic and neuro-hormonal activation.

This study is a single-arm, open label, prospective interventional study of 8 subjects with heart failure with preserved ejection fraction (HFpEF) and diabetes. Before and after 12 weeks of daily empagliflozin, participants with undergo comprehensive invasive exercise testing with a right heart catheter. Our goal is to evaluate the effects of empagliflozin on fitness, assessed by peak VO2, and peak left ventricular filling pressure, assessed by pulmonary capillary pressure at peak exercise.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Boehringer Ingelheim
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• adults ages 50-85, type 2 diabetes mellitus, and clinical heart failure with ejection fraction > 50%

Exclusion Criteria:

• previous hypersensitivity or adverse reaction to SGLT-2 inhibitors, currently treated with SGLT-2 inhibitor, ejection fraction <50%, chronic kidney disease with glomerular filtration rate < 45 ml/kg/min, unstable coronary artery disease, significant arrhythmia, BMI >55 kg/m2 and inability to exercise.