ERtugliflozin triAl in DIabetes with preserved or reduced ejeCtion FrAcTionmEchanistic evaluation in Heart Failure: ERADICATE-HF - ERADICATE-HF

VU University Medical Center0 个研究点目标入组 36 人2018年6月22日

概览

暂无简介。

注册库

who.int

开始日期

2018年6月22日

结束日期

待定

最后更新

5年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

VU University Medical Center

•1\. Male or female subjects diagnosed with T2D \=12 months prior to
•informed consent;
•2\. eGFR \=30 ml/min/1\.73m2;
•3\. Age \>18 years;
•4\. HbA1c 6\.5%\-10\.5%;
•5\. Body Mass Index (BMI) 18\.5\-45\.0 kg/m2;
•6\. Blood pressure \< 160/110 and \> 90/60 at screening,
•7\. Heart failure with New York Heart Association (NYHA) class 2\-3 symptoms and ejection fraction \> 20%
•8\. Stable dose of maximally tolerated ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 30 days
•9\. Stable diuretic dose for at least 30 days at the time of baseline physiological assessment

•1\. Type 1 Diabetes;
•2\. Leukocyte and/or nitrite positive urinalysis that is untreated;
•3\. Severe hypoglycaemia within 2 months prior to screening;
•4\. History of brittle diabetes or hypoglycaemia unawareness based on investigator judgement;
•5\. Unstable coronary artery disease with acute coronary syndrome, percutaneous intervention or bypass surgery within 3 months;
•6\. Clinically significant valvular disease;
•7\. Congestive heart failure secondary to an infiltrative cardiomyopathic process (for example amyloid) or pericardial constriction;
•8\. Uncontrolled systemic hypertension (systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \>110\) or systemic hypotension
•(systolic blood pressure \< 90/60 mmHg);
•9\. Bariatric surgery or other surgeries that induce chronic malabsorption;