EUCTR2016-002225-10-IT进行中（未招募）1 期
Impact of empagliflozin on left ventricular functions: a single center, phase III, randomized, open-label, active treatment-controlled, parallel study in patients with type 2 diabetes and normal left ventricular function - EMPA-HEART
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male of female patients affected by type 2 diabetes mellitus (T2DM)
- •Subjects aged >40 and <80 years
- •HbA1c levels =53 and = 69 mmol/mol
- •Assuming stable hypoglycemic therapy since three months with:
- •Metformin + basal insulin
- •Assuming stable cardio-active therapies since three months (anti-hypertensive drugs, diuretics, drugs for asthma, drugs for migraine)
- •With preserved kidney function as defined by eGFR =45 ml.min-1.1.73m2
- •With preserved left ventricular function as defined by (NYHA class 1-2, and EF=50%)
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •Refuse to give or inability to give informed consent;
- •Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- •Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator;
- •Patients with type 1 diabetes mellitus;
- •Pregnancy or active breast feeding;
- •History of acute coronary syndrome;
- •Respiratory insufficiency or history of clinically significant respiratory diseases (chronic obstructive pulmonary disease);
- •Acute or chronic inflammatory diseases;
- •History of active neoplastic disease within the last 5 years;
- •Patients with known hypersensitivity to empagliflozin and its excipients;
- •Volume depleted patients or those who, in the judgement of the investigator, may be at risk for dehydration (abuse of diuretics or laxatives, chronic diarrhoea etc);
- •History of recurrent or serious genitor-urinary infections;
- •Patients with known hypersensitivity to sitagliptin and its excipients;
- •History of acute or chronic pancreatic disease;
- •Patients who received any investigational new drug within the last 12 weeks;
- •Severe obesity (BMI=40 kg/m2);
- •Uncontrolled blood pressure, defined as >160/100 mmHg;
- •eGFR<45 ml/min/1.73 m2;
- •Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN or total bilirubin >2.0 mg/dL;
- •Cardiac arrhythmia (2nd grade AV block, atrial fibrillation, peace maker, high incidence premature beats);
- •Clinically relevant cardiac valvular disease;
- •Ejection fraction <50% or presence of regional left ventricular contraction impairment;
- •Poor quality of echocardiographic imaging;
- •Inability to perform the cardiopulmonary exercise test;
- •Evidence of inducible myocardial ischemia at the cardiopulmonary test
研究者
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