A multicenter, randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of finerenone compared to eplerenone on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both. - FINESSE-HF

Bayer HealthCare AG0 个研究点目标入组 5,890 人2015年10月30日

适应症Subjects with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both MedDRA version: 18.1Level: LLTClassification code 10076410Term: Chronic kidney disease stage 3System Organ Class: 100000004857 MedDRA version: 18.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861 MedDRA version: 18.1Level: LLTClassification code 10066498Term: Cardiac failure chronic aggravatedSystem Organ Class: 100000004849 MedDRA version: 18.1Level: LLTClassification code 10076408Term: Chronic kidney disease stage 1System Organ Class: 100000004857 MedDRA version: 18.1Level: LLTClassification code 10076409Term: Chronic kidney disease stage 2System Organ Class: 100000004857 Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Subjects with chronic heart failure and reduced ejection fraction after recent heart failure decompensation and additional risk factors, either type 2 diabetes mellitus or chronic kidney disease or both
发起方: Bayer HealthCare AG
入组人数: 5890
状态: 进行中（未招募）
最后更新: 6年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2015年10月30日

结束日期

待定

最后更新

6年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Bayer HealthCare AG

入排标准

入选标准

•\- Women of childbearing potential can only be included in the study if a pregnancy test is negative at Screening and if they agree to use adequate contraception. Adequate contraception is defined as any combination of at least 2 effective methods of birth control, of which at least one is a physical barrier (e.g. condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices). Women are considered post\-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum follicle\-stimulating hormone (FSH) levels \>40 mIU/mL \[for US only: and estradiol \<20 pg/mL] or have had surgical treatment such as bilateral tubal ligation, bilateral ovariectomy, or hysterectomy.
•\- Diagnosis of CHF, NYHA class II\-IV, and documented ejection fraction of \<\=40%
•\- Unscheduled emergency presentation to emergency services (outpatient or hospital, including the emergency department ) due to signs and/or symptoms of HF decompensation in the 2 weeks preceding randomization (considered as index event)
•\- Administration of intravenous (IV) decongestive therapy at any time during presentation and/or admission to emergency services for the treatment of the index event
•\- BNP \>400 pg/mL or NT\-proBNP \>1200 pg/mL in sinus rhythm, and BNP \>600 pg/mL or NT\-proBNP \>1800 pg/mL in atrial fibrillation, at any time starting with the index event, at the latest at screening; ; BNP values are not applicable for subjects taking angiotensin receptor\-neprilysin inhibitors (ARNIs)
•\- Type 2 diabetes mellitus (T2DM) in their medical history or at screening
•Chronic kidney disease (CKD) with moderately reduced kidney function, defined as an estimated glomerular filtration rate (eGFR) between 30 and 60 mL/min/1\.73 m² at screening (calculated using the locally approved and validated equation); one reassessment allowed
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

排除标准

•\- Acute de\-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis, within 3 months prior to randomization
•\- Acute coronary syndrome, including unstable angina, non\-ST segment elevation myocardial infarction (NSTEMI) or ST segment elevation myocardial infarction (STEMI), or major CV surgery including coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy(CRT) device or cardiac contractility modulation (CCM) device, or carotid angioplasty within 3 months prior to randomization
•\- Stroke or transient ischemic cerebral attack within 3 months prior to randomization
•\- Cardiogenic shock at randomization, prior to first intake of study drug
•\- Any primary cause of HF scheduled for surgery , e.g. valve disease such as severe aortic stenosis
•\- History of heart transplant or need for heart transplantation; presence or need of left ventricular assist device