NCT03198585已完成2 期
Empagliflozin in Heart Failure Patients With Reduced Ejection Fraction: A Randomized Clinical Trial (Empire HF)
Morten Schou2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2017年6月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Between-group difference in the change of plasma concentrations of NT-proBNP
研究概览
简要总结
To assess the effect of Empagliflozin on cardiac biomarkers, cardiac function at rest and during stress, cardiac hemodynamics, renal function, metabolism, daily activity level and health-related quality of life in stable, symptomatic heart failure patients with reduced left ventricular ejection fraction.
The primary hypothesis is that 3 months' treatment with Empagliflozin 10 mg a day will reduce the plasma concentrations of N-terminal pro-brain natriuretic peptide (NT-proBNP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Optimal Heart Failure Therapy in accordance with European and National Guidelines
- •LVEF ≤ 0.40
- •eGFR > 30 ml/min/1.73 m2
- •BMI < 45 kg/m2
- •NYHA class I-III
- •Age > 18 years
- •If T2D - optimal treatment in accordance with European and National Guidelines
- •If T2D - stable doses of antiglycemic treatment for 30 days
- •If T2D - HbA1C 6.5-10%
排除标准
- •CRT-D/-P implanted < 90 days
- •Uncorrected severe valvular disease
- •Non-compliance
- •Use of metalozone
- •Age > 85 years
- •Admission for HF < 30 days
- •Admission for hypoglycemia < 12 month
- •Known sustained VT
- •Symptomatic hypotension and systolic BP < 95 mmHg
- •Unable to perform an exercise test
- •Immobilization
- •Pregnancy
- •Participation in other medical trials
- •Previous intolerance of Empagliflozin or excipients
研究组 & 干预措施
Empagliflozin 10 mg
Active Comparator
干预措施: Empagliflozin 10 MG (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Between-group difference in the change of plasma concentrations of NT-proBNP
时间窗: 90 days
次要结局
- Between-group difference in the change of uric acid(90 days)
- Between-group difference in the change of urine albumin/creatinine ratio(90 days)
- Between-group difference in the change in daily activity level measured by patient-worn accelerometers as change in the amount of daily average accelerometer units(90 days)
- Between-group difference in the change in body composition assessed by DXA scan(90 days)
- Between-group difference in the change of estimated extracellular volume assessed by Cr-51 EDTA clearance(90 days)
- Between-group difference in the change of estimated plasma volume assessed by hematocrit and hemoglobin(90 days)
- Between-group difference in the change of glucose metabolism assessed by oral glucose tolerance test(90 days)
- Between-group difference in the change of ketone supply to the heart assessed by blood ketones(90 days)
- Between-group difference in the change of renal function assessed by Cr-51 EDTA clearance(90 days)
- Between-group difference in the change of cardiac biomarkers assessed by plasma concentrations of MR-proADM and hs-cTnI(90 days)
- Between-group difference in the change of cardiac systolic and diastolic function including left ventricular global longitudinal strain and left ventricular ejection fraction assessed by transthoracic echocardiography at rest and during stress(90 days)
- Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including pulmonary capillary wedge pressure to cardiac index ratio(90 days)
- Between-group difference in the change of cardiac hemodynamics during rest and sub-maximal exercise assessed by right heart catheterization including left ventricular contractile reserve(90 days)
- Between-group difference in the change of health-related quality of life assessed by the questionnaire KCCQ(90 days)
- Between-group difference in the change of health-related quality of life assessed by the questionnaire EQ-5D-5L(90 days)
研究者
Morten Schou
MD, PhD, Consultant Cardiologist, Associate Professor
Herlev and Gentofte Hospital
研究点 (2)
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