EUCTR2016-002278-11-RO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 preserved Ejection Fraction (HFpEF).
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 11,583
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 preserved EF defined as LVEF > 40 % per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, MRI or CT), and no prior measurement of LVEF = 40% under stable conditions. A historical LVEF may be used if it was measured within 6 months prior to visit 1, and more than 90 days after any myocardial infarction (as defined in exclusion criterion No.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.
- •- Elevated N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) > 300 pg/ml for patients without AF, OR > 900 pg/ml for patients with AF, analysed at the Central laboratory at Visit 1
- •- Patients must have at least one of the following evidence of HF:
- •a) Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1,
- •b) Documented hospitalisation for HF (HHF) within 12 months prior to Visit 1
- •- Oral diuretics, if prescribed to patient according to local guideline and discretion of the Investigator, should be stable for at least 1 week prior to Visit 2 (Randomisation)
- •- eGFR (CKD-EPI)cr = 20 mL/min/1.73m2 at Visit 1
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2063
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2063
排除标准
- •1. Myocardial infarction, 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. Implantation of cardioverter defibrillator (ICD) within 3 months prior to Visit 1
- •4. Implanted cardiac resynchronisation therapy (CRT)
- •5. Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic
- •obstructive cardiomyopathy or known pericardial constriction
- •6. Any severe valvular heart disease expected to lead to
- •surgery during the trial in the Investigator’s opinion
- •7. Acute decompensated HF requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 1 week from discharge to Visit 1, and during screening period until Visit 2 (Randomisation)
- •8. Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Screening
- •9. Systolic blood pressure (SBP) = 180 mmHg at Visit 2. If SBP >150 mmHg and <180 mmHg at Visit 2, the patient should be receiving at least 3 antihypertensive drugs
- •10. Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 or Visit 2
研究者
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