Effects of empagliflozin on cardiac remodeling and myocardial sympathetic nervous system in diabetic patients affected by chronic heart failure - Empa_MIBG

AOU FEDERICO II0 个研究点目标入组 34 人开始时间: 2020年10月7日最近更新: 2021年7月26日

适应症

试验速览

暂无简介。

•Age =18 years;
•Post-menopausal women, or no-pregnancy state (documented by pregnancy test);
•LVEF = 40% in at least two consecutive transthoracic echocardiographic evaluations;
•Stable clinical conditions (NYHA class II-III);
•Diagnosis of HF since at least 6 months;
•Stable optimal pharmacological HF therapy since at least 6 weeks;
•Type 2 DM with an indication to treatment with empagliflozin;
•Estimated glomerular filtration rate (eGFR) =30 ml/min/1.73m2 according to the
•Modification of Diet in Renal Disease (MDRD) criteria;
•Capability to understand the study procedures and sign the informed consent form.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•Age =75 years;
•Type 1 DM;
•Suspected or known liver disease, defined by serum levels of alanine aminotransferase,
•aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal;
•Planned cardiac surgery (including heart transplantation) or percutaneous coronary
•intervention within 3 months;
•Acute coronary syndrome, stroke, or transient ischemic attack within 2 months before the
•inclusion in the study;
•Estimated glomerular filtration (eGFR) <30 ml/min/1.73m2 according to the Modification of
•Diet in Renal Disease (MDRD) criteria;
•Bariatric surgery within the past two years and other gastrointestinal surgeries that induce
•chronic malabsorption;
•Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;
•Medical history of cancer and/or treatment for cancer within the last 5 years;

发起方

AOU FEDERICO II