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). - None
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 2.
- •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
研究者
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