Empagliflozin to Elderly and Obese Patients With Cardiovascular Disease (Empire Prevent: Metabolic): A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Ventricular epicardial adipose tissue (EAT) mass
研究概览
简要总结
The aim of this trial is to assess the effect of Empagliflozin on lipid and glucose metabolism as well as volume homeostasis and renal function in elderly and obese patients with increased risk of developing heart failure. No history of established heart failure or diabetes is allowed.
The primary hypotheses are that 6 months treatment with Empagliflozin 10 mg a day will: 1) decrease epicardial adipose tissue volume, and 2) reduce estimated extracellular volume compared with placebo.
详细描述
The Empire Prevent: Metabolic is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Cardiac.
The Empire Prevent: Metabolic is designed to enroll at least 120 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index >28kg/m2
- •Age 60-84 years
- •Established risk factor for developing heart failure, defined as at least one of the following:
- •hypertension
- •ischemic heart disease
- •stroke/transient cerebral ischemia
- •chronic kidney disease (eGFR 30-45ml/min/1.73m2)
排除标准
- •Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)
- •Heart failure with reduced ejection fraction (LVEF <40%)
- •Inability to perform exercise test
- •Severe non-compliance
- •Substance abuse
- •Severe chronic obstructive pulmonary disease (FEV1<50% expected value)
- •Permanent atrial fibrillation
- •GFR <30 ml/min/1,73m2
- •Severe peripheral artery disease
- •Cancer treatment within one year beside prostate cancer and basal cell carcinoma
- •Severe aortic or mitral valve disease
- •Pregnancy or breastfeeding
- •Acute hospital admission within 30 days
- •Participation in other pharmacological study
研究组 & 干预措施
Active drug (Empagliflozin)
Empagliflozin 10 mg, 1 capsule per day
干预措施: Empagliflozin 10 MG (Drug)
Inactive drug (placebo)
Placebo, 1 capsule per day
干预措施: Placebo (Drug)
结局指标
主要结局
Ventricular epicardial adipose tissue (EAT) mass
时间窗: 180 days
Between-group difference in the change of EAT mass assessed by cardiac magnetic resonance imaging (MRI)
Estimated extracellular volume (eECV)
时间窗: 180 days
Between-group difference in the change of eECV assessed by 99mTc-DTPA clearance (technetium-99mTc-diethylenetriaminepentaacetic acid)
次要结局
- Total pericardial adipose tissue volume(180 days)
- Total epicardial adipose tissue (EAT) volume(180 days)
- Plasma volume(180 days)
- Right ventricular end-diastolic volume index, RVEDVI(180 days)
研究者
Jacob Moller
Professor, MD, PhD
Odense University Hospital