The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Mitral early (E) and late (A) diastolic filling velocity ratio (E/A)
研究概览
简要总结
The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥20 years old
- •ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
- •Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.
排除标准
- •Age <20 years old
- •Ongoing pregnancy
- •NYHA class IV heart failure
- •Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of screening
- •Known acute genital infection
- •Severe peripheral artery disease (Rutherford category 4-6)
- •Acute coronary syndrome, stroke or transient ischemic attack within the past month
- •Recent initiation of chronic maintenance hemodialysis within 6 months
- •Adjustment of dry weight with changes greater than 5% of body weight within the past month
- •Documented left ventricular ejection fraction =<40% by any imaging modality within 1 month of screening
- •Refused informed consent
研究组 & 干预措施
empagliflozin
Jardiance, 25 mg, QD, for 6 months
干预措施: Empagliflozin 25 MG (Drug)
Placebo
QD, for 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
Mitral early (E) and late (A) diastolic filling velocity ratio (E/A)
时间窗: 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
次要结局
- Hypoglycemic events(24 weeks of treatment)
- LV end-systolic volume index(12 weeks and 24 weeks of treatment)
- LV end-diastolic volume index(12 weeks and 24 weeks of treatment)
- LA volume index(12 weeks and 24 weeks of treatment)
- All-cause mortality(24 weeks of treatment)
- LV ejection fraction(12 weeks and 24 weeks of treatment)
- Hospitalization for heart failure(24 weeks of treatment)
- Left ventricular mass index(12 weeks and 24 weeks of treatment)
- Global longitudinal strain(12 weeks and 24 weeks of treatment)
- LA strain(12 weeks and 24 weeks of treatment)
- Mitral inflow deceleration time(12 weeks and 24 weeks of treatment)
- Mitral inflow deceleration time LV relative wall thickness(12 weeks and 24 weeks of treatment)
- Tricuspid regurgitation peak gradient (TRPG)(12 weeks and 24 weeks of treatment)
- NT-proBNP(4 weeks, 12 weeks and 24 weeks of treatment)
- HbA1c(4 weeks, 12 weeks and 24 weeks of treatment)
- Lipid profile(4 weeks, 12 weeks and 24 weeks of treatment)
- KCCQ-OS(12 weeks and 24 weeks of treatment)
- 6-minute walking distance(12 weeks and 24 weeks of treatment)
- 3-minute heart rate variability(12 weeks and 24 weeks of treatment)
- Blood pressure(12 weeks and 24 weeks of treatment)
- Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke)(24 weeks of treatment)
- Lower extremity non-traumatic amputation or revascularization(24 weeks of treatment)
- Diabetic ketoacidosis(24 weeks of treatment)
- Urinary tract infection(24 weeks of treatment)
- Genital tract infection(24 weeks of treatment)
- Hypokalemia(4 weeks, 12 weeks and 24 weeks of treatment)