Management of the patient with heart failure and diabetes: may insulin be a problem? A pilot randomized clinical study (Insulin-HF). - Insulin-HF

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 个研究点目标入组 142 人开始时间: 2020年11月5日最近更新: 2020年11月9日

适应症

试验速览

暂无简介。

•1.Men and women aged =70 years;
•2.at discharge after admission to hospital for worsening of HF or ambulatory patients with chronic HF;
•3.New York Heart Association (NYHA) class II or III;
•4.with any level of left ventricular ejection fraction;
•5.plasma natriuretic peptide (BNP) =200 pg/mL or N-terminal pro-BNP =900 pg/mL (NT pro-BNP)
•6.prior history or newly diagnosed T2DM
•7.candidate by the responsible physician to insulin therapy;
•8.signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 142

•1.significant renal insufficiency (GFR <30 mL/min/1.73 m2) or severe liver disease (liver function test abnormalities (alanine or aspartate aminotransferase = 3 × upper limit of normal [ULN]);
•2.levels of hemoglobin <10 g/dl;
•3.HbA1c =5% or =11%;
•4.unstable diabetes: type of diabetes presentation in patients with an anamnesis of frequent episodes of hypoglycemia, hyperglycemic hyperosmolar status, ketoacidosis or lacto acidosis;
•5.planned CV surgery or angioplasty in 3 months;
•6.any non-cardiac disease that shortens life expectancy to<1 year (e.g. most cancers);
•7.inability to comply with study protocol;
•8.participation to another interventional clinical study.

发起方

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI