A Phase 4 interventional study of Empagliflozin 10 MG in Heart Failure with Preserved Ejection Fraction, Heart Failure, Diastolic and Diabetes Mellitus, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment
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.
This is a single-arm, open label, pilot study of 8 subjects with HFpEF. The subjects will undergo screening tests (exercise stress echo and blood work) to evaluate for potential exclusion criteria and provide familiarization to the exercise protocol. Those included will undergo an echocardiogram and invasive cardiopulmonary exercise test. This involves placement of a right heart catheter in the pulmonary artery and undergoing seated, upright exercise. During the exercise test, the subject's oxygen uptake (VO2), intra-cardiac pressures (right atrial pressure, pulmonary capillary wedge pressure) and cardiac output (Qc) will be measured. The subject will take a dose of empagliflozin in the lab and wait for at least 60 minutes. They will repeat a shortened version of the exercise test in the afternoon. After baseline testing, each subject will take 10mg empagliflozin daily for 12 weeks. They will have repeat blood work (specific electrolytes and renal function) 30 days after starting medication to screen for renal injury. After 12 weeks, they will return for another invasive cardiopulmonary exercise test and echocardiogram.
5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 8 is below the median of 72 across 3,737 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 101 (75%) have results posted.
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Exclusion Criteria:
This arm of the study will take 10 mg empagliflozin daily for 12 weeks
Drug: Empagliflozin 10 MG
Daily Empagliflozin
Peak Oxygen Uptake
Peak VO2 measured on maximal exercise test
Time frame: 12 weeks
Peak Pulmonary Capillary Wedge Pressure (PCWP)
Peak PCWP, measured at end-expiration, at the end of maximal exercise test
Time frame: 12 weeks
Primary Endpoints after single dose of empagliflozin
Peak VO2 and peak PCWP will be measured after a single dose of empagliflozin
Time frame: 1 hour
Cardiac Output at Rest and During Exercise
Time frame: 12 weeks
Stroke Volume at Rest and During Exercise
Time frame: 12 weeks
Right Atrial Pressure at Rest and During Exercise
Time frame: 12 weeks
Pulmonary Capillary Wedge Pressure at Rest and During Submaximal Exercise
Time frame: 12 weeks
Left ventricular volumes at rest and during submaximal exercise
Measured by echocardiography
Time frame: 12 weeks
Hemoglobin mass, plasma volume, total blood volume
Measured by Carbon Monoxide Rebreathe
Time frame: 12 weeks
Diastolic parameters at rest and during submaximal exercise
Measured by echocardiography
Time frame: 12 weeks
6 minute walk time
Time frame: 12 weeks
Plan to share: No — De-identified data may be made available upon reasonable request
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center