Impact of Empagliflozin on Functional Capacity in Heart Failure with Preserved Ejection Fraction
Completed · Phase 4
Conditions studied: Heart Failure with Preserved Ejection Fraction, Heart Failure, Diastolic, Diabetes Mellitus
In brief
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). 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.
Key facts
- Study ID
- NCT05139472
- Run by
- University of Texas Southwestern Medical Center
- People needed
- 8
- Starts
- 2021-11-09
- Expected to finish
- 2024-02-19
- Last updated by the study team
- 2024-09-19
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- adults ages 50-85
- clinical heart failure
- ejection fraction > 50%
You may not qualify if…
- previous hypersensitivity or adverse reaction to SGLT-2 inhibitors
- currently treated with SGLT-2 inhibitor
- current or prior ejection fraction <50%
- chronic kidney disease with glomerular filtration rate < 45 ml/kg/min
- unstable coronary artery disease
- significant arrhythmia
- BMI >55 kg/m2
- inability to exercise.
Where it is running
- Institute for Exercise and Environmental Medicine — Dallas, Texas, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.