EUCTR2020-005713-40-FR招募中1 期
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure patients on heart transplant waiting list: a multicenter, double-blind, randomized clinical trial. - ARCADIA-HF
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
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
- 性别
- All
入选标准
- •1)Patient has signed informed consent form
- •2)Age = 18 years
- •3)NYHA class =3
- •4)LVEF = 35%
- •5)On optimal medical management (OMM) based on current heart failure practice guidelines at maximal tolerated dose for at least 30 days
- •6)On waiting list for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant = 6 months
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1)Priority patient on waiting list for heart transplantation
- •2)Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
- •3)Inotrope dependent, existence of ongoing mechanical circulatory support
- •4)Current acute decompensated HF or hospitalization due to decompensated HF <30 days prior to the enrolment
- •5)History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization
- •6)Presence of an active, uncontrolled infection
- •7)Any recent interventional procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) < 60 days
- •8)Glomerular filtration rate < 30 ml/min/1.73 m2, according to CKD-EPI formula
- •9)Unstable or rapidly progressing renal disease
- •10)Patients with severe hepatic impairment (Child-Pugh class C)
- •11)Chronic treatment with dapagliflozin or other SGLT2 inhibitors
- •12)Patient with known history of severe drug intolerance to dapagliflozin or any excipients of the dapagliflozin (galactose, lactase)
- •13)Type 1 diabetes mellitus
- •14)Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or extraction of study drug at investigators’ discretion
- •15)Participation in another clinical interventional trial
- •16)Any condition other than heart failure that could limit survival to less than 24 months
- •17)Positive pregnancy test if of childbearing potential or refusal to use adequate contraception or women breast-feeding
- •18)Patients with any legal protection measure
- •19)Patients without any health coverage
- •20)Psychiatric disease/disorder, irreversible cognitive dysfunction or psychological issues that are likely to impair compliance
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