CTRI/2017/08/009371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 reduced Ejection Fraction (HFrEF).
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,850
- 试验地点
- 13
- 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 HFrEF.
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 on top of guideline-directed medical therapy in patients with symptomatic, chronic HF and reduced ejection fraction (LVEF ≤ 40%).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 HFrEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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 then or equal to 18 years at screening.
- •For Japan only: Age Greater than or equal to 20 years at screening Appropriate dose of medical therapy for HF consistent with prevailing local and international CV (Cardiovascular) guidelines, stable for at least 1 week prior to Visit 1 Appropriate use of medical devices such as cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international CV guidelines, unless it is implanted within 3 months prior to Visit 1 Signed and dated written ICF (Informed Consent Form) Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association Classification) class 2-4 and reduced EF (Ejection Fraction) (LVEF (Left Ventricular Ejection Fraction) less than equal to 40 percent) and elevated NT-pro BNP (N-terminal of the prohormone brain natriuretic peptide) -If EF greater then equal to 36 percent to less than equal to 40 percent NT-pro BNP greater then equal to 2500 pg per ml -If EF greater then equal to 31 percent to less than equal to 35 percent NT-proBNP greater than equal to 1000 pg per ml -If EF less than equal to 30% NT-proBNP greater than equal to 600 pg per ml.
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
- •Systolic blood pressure (SBP) greater than 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 per min/1.73 m2 (CKD-EPI (Chronic Kidney Disease.
- •Epidemiology Collaboration Equation)) 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 study
- •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 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 HFrEF.
时间窗: 38 months
次要结局
- •Occurrence of adjudicated HHF (first and recurrent)(During entire study)
- •eGFR (CKD-EPI) slope of change from baseline(During entire study)
- Time to first event of sustained reduction of ≥40% eGFR (CKD-EPI) or(•sustained eGFR (CKD-EPI) 15 mL/min/1.73 m2 for patients with baseline eGFR ≥30 mL/min/1.73 m2)
- •sustained eGFR (CKD-EPI) 10 mL/min/1.73 m2 for patients with baseline eGFR 30 mL/min/1.73 m2(During entire study)
- •Time to first adjudicated HHF(During entire study)
- •Time to adjudicated CV death(During entire study)
- •Time to all-cause mortality(During entire study)
- •Time to onset of diabetes mellitus (DM) in patients with pre-DM(week 148)
- •Change from baseline in clinical summary score (HF symptoms and physical limitations domains) of the KCCQ(week 52)
- •Occurrence of all-cause hospitalisation (first and recurrent)(during entire study)
研究者
研究点 (13)
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