Cardiac Metabolic Modulator Treatment for Improvement of Left Ventricular Diastolic Function in Patients With Coronary Heart Disease: a Prospective, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Percentage difference of patients with II or III degree diastolic dysfunction in each arm
研究概览
简要总结
Based on accumulating evidence showing that impaired cardiac energetic metabolism plays important role in the mechanism of cardiac diastolic dysfunction,the study is designed to evaluate whether metabolic modulator treatment with trimetazidine could have beneficial effects on patients with coronary heart disease(CHD) and ventricular diastolic dysfunction.This study is a prospective,randomised,open-label trial to assess the efficacy of trimetazidine treatment in improving diastolic function in CHD patients with diastolic dysfunction.
详细描述
The primary objective of this trial is to determine whether the 24-week trimetazidine therapy, as an adjunct to routine treatment for CHD, would improve diastolic function in patients with ischemic heart disease compared to the routine treatment.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 50 and 79 years,male or female (without pregnancy).
- •Diagnosed CHD by coronary angiography,with stenoses in main bifurcations less than 70% after PCI treatment.
- •Left ventricular ejection fraction(LVEF) more than 50% assessed by ultracardiography.
- •Characteristics of diastolic dysfunction by ultracardiography (more than 2 criteria as following):(1)Average E/e'>14,(2)Septal e' velocity <7 cm/s or lateral e' velocity <10 cm/s,(3)Tricuspid regurgitation (TR) velocity >2.8m/s,(4)Left atrium (LA) volume index >34ml/m
- •Not yet being treated by trimetazidine.
- •Provided informed consent.
排除标准
- •Acute heart failure or acute exacerbation of chronic heart failure.
- •LVEF less than 50% at admission or in the past.
- •History of malignant tumor or life expectancy under 12 months.
- •Acute myocardial infarction or unstable angina pectoris within 3 months.
- •Scheduled coronary artery bypass grafting therapy within 6 months.
- •Diagnosed or considered valvular heart disease, hypertrophic cardiomyopathy,restrictive cardiomyopathy or pericardium diseases.
- •Significant hepatic impairment (Serum glutamate-pyruvate transaminase more than 3 times normal upper limit) or severe renal dysfunction (eGFR≤30 ml/min/1.73m2).
- •Known or considered Parkinson's Disease.
- •Known hypersensitivity or intolerance to trimetazidine.
- •Pregnancy and lactation period.
- •Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol.
- •Participation in another clinical trial within the past 30 days.
研究组 & 干预措施
CHD routine therapy+Trimetazidine
Apart from the drug and PCI therapy mentioned above,patients will be given treatment of trimetazidine.
干预措施: Trimetazidine (Drug)
结局指标
主要结局
Percentage difference of patients with II or III degree diastolic dysfunction in each arm
时间窗: Within 6 months after patients being enrolled
II or III degree diastolic dysfunction is defined as average E/e' ratio more than 10
次要结局
- Average E/e' ratio change between week 24 and baseline(Within 6 months after patients being enrolled)
- E' velocity change of septum or of left ventricular lateral wall in m/s between week24 and baseline(Within 6 months after patients being enrolled)
- Velocity of tricuspid regurgitation change in m/s between week 24 and baseline(Within 6 months after patients being enrolled)
- Index of left atrium volume change between week 24 and baseline(Within 6 months after patients being enrolled)
- Concentration of the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) change in pg/ml between week 24 and baseline(Within 6 months after patients being enrolled)
- Number of participants with cardiovascular death and being rehospitalized for heart failure within 24 weeks treatment(Within 6 months after patients being enrolled)
- Concentration of glycated hemoglobin (HbA1c) change in patients with diabetes mellitus (DM) between week 24 and baseline(Within 6 months after patients being enrolled)