CTRI/2017/09/009734进行中（未招募）3 期
A phase III randomised, double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10 mg compared to placebo, in patients with chronic Heart Failure with preserved Ejection Fraction (HFpEF).
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,126
- 试验地点
- 14
- 主要终点
- The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated Hospitalisation for Heart Failure in patients with Heart Failure with preserved Ejection Fraction (HFpEF).
研究概览
简要总结
The objective of this event-driven trial is to demonstrate superiority of empagliflozin 10 mg versus placebo in patients with symptomatic, chronic HF and preserved ejection fraction (LVEF > 40%) under stable treatment of HF symptoms. This randomised, double-blind, multi-national, parallel group trial compares empagliflozin 10 mg once daily to placebo as add-on to standard of care treatment in patients with HFpEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patient, age greater than or equal to 18 years at screening.
- •For Japan only: Age Greater than or equal to 20 years at screening Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the prohormone brain natriuretic peptide) > 300 pg/ml for patients without AF, OR Greater than 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1 Structural heart disease within 6 months prior to Visit 1, OR documented HHF (Hospitalisation for Heart Failure) within 12 months prior to Visit 1 Stable dose of oral diuretics, if prescribed Signed and dated written ICF (informed consent form) Further inclusion criteria apply.
排除标准
- •Myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days prior to Visit 1 Heart transplant recipient or listed for heart transplant Acute decompensated HF (Heart Failure) Systolic blood pressure (SBP) greater than or equal to 180 mmHg at Visit
- •Symptomatic hypotension and/or a SBP less than 100 mmHg Indication of liver disease, Impaired renal function, defined as eGFR (Estimated Glomerular Filtration Rate) less than 20 mL/min/1.73 m2 (CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration Equation))cr or requiring dialysis History of ketoacidosis Treatment with any SGLT (Sodium-glucose co-transporter) -2 inhibitor or combined SGLT-1 and 2 inhibitor Currently enrolled in another investigational device or drug trial Known allergy or hypersensitivity to empagliflozin or other SGLT-2 inhibitors Women who are pregnant, nursing, or who plan to become pregnant while in the trial Further exclusion criteria may apply.
结局指标
主要结局
The composite primary endpoint for this trial is the time to first event of adjudicated CV death or adjudicated Hospitalisation for Heart Failure in patients with Heart Failure with preserved Ejection Fraction (HFpEF).
时间窗: up to 38 months
次要结局
- Occurrence of adjudicated HHF (first and recurrent)(up to 38 months)
- eGFR (CKD-EPI)cr slope of change from baseline(up to 38 months)
- Time to first occurrence of sustained reduction of ≥40% eGFR(CKD-EPI)cr or sustained eGFR (CKD-EPI)cr 15 mL/min/1.73 m2 for patients with baseline eGFR ≥30 mL/min/1.73 m2 of sustained eGFR (CKD-EPI)cr 10 mL/min/1.73 m2 for patients with baseline eGFR 30 mL/min/1.73 m2(up to 38 months)
- Time to first adjudicated HHF(up to 38 months)
- Time to adjudicated CV death(up to 38 months)
- Time to all-cause mortality- during the entire studyTime to onset of diabetes mellitus (DM) in patients with pre-DM(up to 38 months)
- Change from baseline in clinical summary score (HF symptoms and physical limitations domains) of the KCCQ(week 52)
- Occurrence of all-cause hospitalization (first and recurrent)(up to 38 months)
研究者
研究点 (14)
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