Impact of Empagliflozin on Functional Capacity in Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Peak Oxygen Uptake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults ages 50-85
- •clinical heart failure
- •ejection fraction > 50%
排除标准
- •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.
研究组 & 干预措施
Treatment Arm
This arm of the study will take 10 mg empagliflozin daily for 12 weeks
干预措施: Empagliflozin 10 MG (Drug)
结局指标
主要结局
Peak Oxygen Uptake
时间窗: 12 weeks
Peak VO2 measured on maximal exercise test
Peak Pulmonary Capillary Wedge Pressure (PCWP)
时间窗: 12 weeks
Peak PCWP, measured at end-expiration, at the end of maximal exercise test
次要结局
- Left ventricular volumes at rest and during submaximal exercise(12 weeks)
- Pulmonary Capillary Wedge Pressure at Rest and During Submaximal Exercise(12 weeks)
- 6 minute walk time(12 weeks)
- Primary Endpoints after single dose of empagliflozin(1 hour)
- Cardiac Output at Rest and During Exercise(12 weeks)
- Stroke Volume at Rest and During Exercise(12 weeks)
- Right Atrial Pressure at Rest and During Exercise(12 weeks)
- Hemoglobin mass, plasma volume, total blood volume(12 weeks)
- Diastolic parameters at rest and during submaximal exercise(12 weeks)
研究者
James MacNamara
Assistant Professor of Medicine
University of Texas Southwestern Medical Center