The effects of sacubitril/valsartan compared to valsartan on left ventricular remodelling in patients with asymptomatic left ventricular systolic dysfunction after myocardial infarction: a randomised, double-blinded, active-comparator, cardiac-MR based trial. - RECOVER-LV

HS Greater Glasgow and Clyde0 个研究点目标入组 100 人开始时间: 2018年6月8日最近更新: 2018年6月11日

适应症

试验速览

暂无简介。

•Acute myocardial infarction at least 3 months prior to recruitment
•Left ventricular ejection fraction = 40% as measured by transthoracic echocardiography
•Ability to provide written, informed consent
•Age =18 years
•Tolerance of a minimum dose of ACE inhibitor/ARB (ramipril 2.5mg BD or equivalent)
•Treatment with a beta-blocker unless not tolerated or contraindicated.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Contraindication to CMR (ferrous prosthesis, implantable cardiac device or severe claustrophobia)
•Clinical and/or radiological heart failure (NYHA=2)
•Symptomatic hypotension and/or systolic blood pressure <100mmHg
•eGFR < 30 mL/min/1.73m2 and/or serum potassium >5.2mmol/L
•Persistent/permanent atrial fibrillation
•History of AMI within last 3 months
•History of hypersensitivity or allergy to ACE-inhibitors/ARB
•History of angioedema
•Known hypersensitivity to the active study drug substances, contrast media or any of the excipients
•Obesity (where body girth exceeds MRI scanner diameter)
•Pregnancy, planning pregnancy, or breast feeding
•Inability to give informed consent or comply with study protocol
•Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x ULN at Visit 1, history of hepatic encephalopathy, history of oesophageal varices, or history of portacaval shunt
•History of biliary cirrhosis and cholestasis
•Active treatment with cholestyramine or colestipol resins
•Active treatment with lithium or direct renin inhibitor
•Participation in another intervention study involving a drug or device within the past 90 days (co-enrolment in observational studies is permitted)

发起方

HS Greater Glasgow and Clyde