Initiation of angiotensin receptor-neprilysin inhibitor (ARNi) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) in patients with heart failure with reduced ejection fraction (HFrEF): the INITIATE-HFrEF randomized open-label trial - INITIATE-HFrEF

niversity Of Porto0 个研究点目标入组 172 人开始时间: 2023年1月24日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Age = 18 years, Heart failure symptoms (NYHA II, III or IV), Left ventricle ejection fraction = 49% (assessed by transthoracic echocardiogram), Glomerular filtration rate = 25 ml/min/1.73m2 (CKD-EPI formula), Serum potassium (K+) = 5.4 mmol/L, Systolic blood pressure = 100 mmHg, Not treated with ARNi nor with SGLT2i within the previous month (30 days before inclusion, except if initiated 5 days before randomization), If female, female patient of non-childbearing potential (detailed in full protocol), If female patient of childbearing potential, she must have a negative serum pregnancy test at Visit 1 (Day 0) and must agree to use one highly effective method of contraception (detailed in full protocol) consistently and correctly

•Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site), Previously confirmed cardiac amyloidosis, History of angioedema, Implantable cardioverter-defibrillators or cardiac resynchronization therapy within 3 months prior to screening or if there is an intent to implant either device in the 3 months following screening, Female patients currently pregnant (confirmed by a positive pregnancy test) or intent to become pregnant or breast feeding, Severe valvulopathy according to the echocardiogram report, Previous history of ketoacidosis due to SGLT2i, Participation in another clinical study with an investigational product during the last month, Unwilling to sign inform consent, Patients with a known hypersensitivity or intolerance to ARNi or SGLT2i or any of the excipients of the products, Hospitalization due to non-cardiovascular causes, surgical procedure, coronary, cerebral or peripheral vascular events or sepsis in the prior month, Cancer (life limiting with an estimated life expectancy of less than 2 years based on investigator’s judgement)

发起方

niversity Of Porto