Diabetes Mellitus Clinical Trial
Official title:
Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction
Verified date | February 2024 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | February 19, 2024 |
Est. primary completion date | September 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: - adults ages 50-85 - clinical heart failure - ejection fraction > 50% Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Institute for Exercise and Environmental Medicine | Dallas | Texas |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | Boehringer Ingelheim |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak Oxygen Uptake | Peak VO2 measured on maximal exercise test | 12 weeks | |
Primary | Peak Pulmonary Capillary Wedge Pressure (PCWP) | Peak PCWP, measured at end-expiration, at the end of maximal exercise test | 12 weeks | |
Secondary | Primary Endpoints after single dose of empagliflozin | Peak VO2 and peak PCWP will be measured after a single dose of empagliflozin | 1 hour | |
Secondary | Cardiac Output at Rest and During Exercise | 12 weeks | ||
Secondary | Stroke Volume at Rest and During Exercise | 12 weeks | ||
Secondary | Right Atrial Pressure at Rest and During Exercise | 12 weeks | ||
Secondary | Pulmonary Capillary Wedge Pressure at Rest and During Submaximal Exercise | 12 weeks | ||
Secondary | Left ventricular volumes at rest and during submaximal exercise | Measured by echocardiography | 12 weeks | |
Secondary | Hemoglobin mass, plasma volume, total blood volume | Measured by Carbon Monoxide Rebreathe | 12 weeks | |
Secondary | Diastolic parameters at rest and during submaximal exercise | Measured by echocardiography | 12 weeks | |
Secondary | 6 minute walk time | 12 weeks |
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