EUCTR2015-002168-17-IT进行中（未招募）1 期
Studio multicentrico, randomizzato, in doppio cieco, a gruppi paralleli, con doppio double dummy, controllato con un farmaco attivo, per valutare l¿efficacia e la sicurezza di finerenone in confronto ad eplerenone sulla morbilit¿ e mortalit¿ in pazienti affetti da insufficienza cardiaca cronica e ridotta frazione di eiezione dopo recente episodio di scompenso, dell¿insufficienza cardiaca ed altri fattori di rischio aggiuntivi, o diabete di tipo 2 o nefropatia cronica od entrambi - FINESSE-HF
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BAYER AG
- 入组人数
- 99,999
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
- •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 anytime 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 and/orChronic 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
- •F.1.2.1 Number of subjects for this age range 1944
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3946
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
研究者
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