NCT03753087已完成4 期
A Phase 4, Single-center, Randomized, Parallel Group Study to Assess Effects of Empagliflozin on Exercise Capacity and Left Ventricular Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction and Type-2 Diabetes Mellitus
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年1月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in 6-minute walking distance (6MWD)
研究概览
简要总结
Patients enrolled into the study will be randomly allocated either to Empagliflozin group or control group. In the Empagliflozin group patients will be receiving standard care + Empagliflozin 10 mg o.d., in the control group patients will be receiving standard care without sodium glucose contransporter 2 (SGLT2) inhibitors.
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
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 45 to 80 years at screening
- •Diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks
- •HbA1c ≥ 6,5% and ≤ 10% at screening
- •Diagnosis of HFpEF which includes:
- •Symptoms ± signs (as defined in 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure)
- •Ejection fraction ≥ 50% (by Simpson)
- •Increased LV filling pressures at rest or during exercise determined by echocardiography (LV diastolic dysfunction grade II/III and/or positive diastolic stress test) [according to American Society of Echocardiography and European Association of Cardiovascular Imaging (ASE/EACVI) Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography, 2016]
- •Signed and dated informed consent
排除标准
- •Pretreatment with empagliflozin or other SGLT-2 inhibitor within the last 2 months
- •Type-1 diabetes mellitus
- •NYHA classification IV or acute decompensated heart failure at screening
- •Impaired renal function, defined as eGFR <30 ml/min/1.73 m² of body-surface-area (CKD-EPI)
- •Systolic blood pressure > 180 mmHg or < 90 mmHg
- •Permanent atrial flutter or atrial fibrillation
- •Other conditions that may be responsible for impaired diastolic function such as hypertrophic/restrictive cardiomyopathy, constrictive pericarditis and etc.
- •Anemia (Hb < 100 g/l)
- •Myocardial infarction, coronary artery bypass graft surgery within the last 3 months
- •Stroke or TIA within the last 3 months
- •Indications of liver disease
- •Acute genital infection or urinary tract infection
- •Additional exclusion criteria may apply
研究组 & 干预措施
Empagliflozin
Experimental
Patients will receive standard care for Heart Failure and Diabetes Mellitus + Empagliflozin 10mg once daily
干预措施: Empagliflozin (Drug)
Control
Active Comparator
Patients will receive standard care for Heart Failure and Diabetes Mellitus with no SGLT-2 inhibitors
干预措施: Standard care (Other)
结局指标
主要结局
Change in 6-minute walking distance (6MWD)
时间窗: 24 weeks
Difference in distance walked during 6-minute walking test (6MWT) between 24 weeks after baseline and at baseline
次要结局
- Change in average E/e' ratio(24 weeks)
- Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)(24 weeks)
- Change in left atrial stiffness(24 weeks)
- Change in average e' velocity(24 weeks)
- Change in Endothelin 1 (ET-1)(24 weeks)
- Change in ST2(24 weeks)
- Change in carboxyterminal propeptide of type I collagen (PICP)(24 weeks)
- Change in Human Pentraxin 3 (PTX3)(24 weeks)
- Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) score(24 weeks)
- Change in Interleukin-6 (IL-6)(24 weeks)
- Change in left ventricular mass index (LVMI)(24 weeks)
- Change in left atrial volume index (LAVI)(24 weeks)
- Change estimated pulmonary artery systolic pressure (PASP)(24 weeks)
- Change in Cyclic guanosine monophosphate (cGMP)(24 weeks)
- Change in Growth/differentiation factor 15 (GDF-15)(24 weeks)
- Change of New York Heart Association (NYHA) functional classification(24 weeks)
- Change in Galectin-3(24 weeks)
- Change in high-sensitivity C-reactive protein (hsCRP)(24 weeks)
研究者
Anton Borisov
Principal Investigator, MD
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
研究点 (1)
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