EUCTR2016-002280-34-GB进行中（未招募）1 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). - Study 1245.121: Empagliflozin Compared to Placebo
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients with chronic HF diagnosed for at least 3 months before Visit 1 and currently in HF New York Heart Association (NYHA)class II-IV
- •- Chronic HF with reduced EF defined as LVEF = 40% per local reading (obtained under stable condition by echocardiography, radionuclide ventriculography, invasive angiography, MRI or CT). A historical LVEF may be used if it was measured within 6 months prior to visit 1 or the LVEF may be measured after study consent has been obtained. The LVEF must be documented in an official report prior to randomization.
- •- In addition to LVEF = 40%, patients must have at least one of the following evidence of HF:
- •a) If EF =36% to =40%: Elevated NT-proBNP at Visit 1 =2500 pg/ml for patients without AF, OR =5000 pg/ml for patients with AF, analysed at the Central Laboratory,
- •b) If EF =31% to =35%: Elevated NT-proBNP at Visit 1 =1000 pg/ml for patients without AF, OR =2000 pg/ml for patients with AF, analysed at the Central Laboratory,
- •c) If EF=30%: Elevated NT-proBNP at Visit 1 =600 pg/ml for patients without AF, OR =1200 pg/ml for patients with AF, analysed at the Central Laboratory
- •d) For EF = 40% and documented HHFc within 12 months prior to visit 1, elevated NT-proBNP at Visit 1 = 600 pg/ml for patients without AF and = 1200 pg/ml for patients with AF, analysed at the Central Laboratory.
- •- Appropriate dose of medical therapy for HF (such as ACEi, ARB, ß-blocker, oral diuretics, MRA, ARNI, ivabradine) consistent with prevailing local and international CV guidelines, stable for at least 1 week prior to Visit 1 and during screening period until Visit 2 with exception of diuretics stable for only one week prior to Visit 2 to control symptoms.
- •- 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 implanted within 3 months prior Visit 1, or if intent to implant ICD or CRT
- •8. Body Mass Index < 45 kg/m2 at Visit 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1675
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1675
排除标准
- •1. Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery, or other major cardiovascular surgery, stroke or TIA in past 90 days prior to Visit 1
- •2. Heart transplant recipient, or listed for heart transplant
- •3. Currently implanted left ventricular assist device (LVAD)
- •4. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), hypertrophic obstructive cardiomyopathy or known pericardial constriction
- •5. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial in the investigator’s opinion
- •6. Acute decompensated HF (exacerbation of chronic HF) requiring i.v. diuretics, i.v. inotropes, or i.v. vasodilators, or LVAD within 1 week from discharge to Visit 1 (Screening) and during screening period until Visit 2 (Randomisation)
- •7. Atrial fibrillation or atrial flutter with a resting heart rate >110 bpm documented by ECG at Visit 2 (Randomisation)
- •8. Untreated ventricular arrhythmia with syncope in patients without ICD documented within the 3 months prior to Visit 1
- •9. Diagnosis of cardiomyopathy induced by chemotherapy or peripartum within the 12 months prior to Visit 1
- •10. Symptomatic bradycardia or second or third degree heart block without a pacemaker after adjusting beta-blocker therapy, if appropriate
研究者
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