Efficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex: a Multicenter, Randomized, Double-blind, Parallel Controlled Clinical Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 584
- 主要终点
- Effective rate of 24-h number of PVCs after 8-week treatment.
研究概览
简要总结
Objective: investigators investigated the effects of metoprolol tartrate plus Tongmai Yangxin Pill on premature ventricular complexes and cardiac function in patients with premature ventricular complex.
Methods: In total, 584 participants with premature ventricular complex will be randomly assigned (at a 1:1 ratio) into two groups: study group (metoprolol tartrate [25 mg twice per day, orally] plus Tongmai Yangxin Pill [40 pills twice per day, orally]) and control group (metoprolol tartrate [25 mg twice per day, orally] plus placebo [40 simulated pills twice per day, orally]). The total treatment period is 8 weeks.
Efficacy endpoints and safety assessment:
Primary efficacy endpoints are as follows: change in 24-h number of PVCs after treatment and effective rate of 24-h number of PVCs after treatment. Secondary efficacy endpoints are as follows: change in New York Heart Association classification; total effective rate of comprehensive effect; change in high-sensitivity C-reactive protein level; and change in echocardiography parameters (i.e., left ventricular ejection fraction, left ventricular end diastolic dimension, E/A, cardiac index, cardiac output, and stroke volume).
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 (Participant, Investigator)
盲法说明
Prior to the start of the study, the sponsor (or contract research organization) and statistician will make masking of the research drugs. The statistician in this study used statistical software to generate random coding table according to the method of stratified block randomization. Personnel who have no involvement in this study will paste the corresponding drug number on the drug packaging according to the random coding.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lown PVC grade, II-IVA;
- •in patients with coronary heart disease and comorbid PVC or non-organic heart disease, the PVC frequency was 3000-30000 times/24 h;
- •New York Heart Association grade, I or II;
- •ejection fraction, ≥45%;
- •written informed consent to participate in the trial.
排除标准
- •presence of bradyarrhythmia (<50 beats/min), including sinus syndrome and atrioventricular block (second or third degree atrioventricular block);
- •presence of persistent ventricular tachycardia, non-persistent ventricular tachycardia, and/or persistent atrial fibrillation;
- •presence of severe PVC requiring treatment with other antiarrhythmic drugs; -presence of drug-induced, electrolyte-induced, or acid-base-induced arrhythmia;
- •presence of uncontrolled or severe hypertension (e.g., grade ≥3 hypertension);
- •presence of uncontrolled diabetes; presence of alanine aminotransferase or aspartate aminotransferase level ≥1.5-fold above the upper limit of normal, urea nitrogen level ≥1.2-fold above the upper limit of normal, and/or blood creatinine above the upper limit of normal;
- •presence of severe respiratory dysfunction or asthma;
- •presence of primary hematopoietic diseases, other systemic diseases (e.g., hyperthyroidism), poor peripheral circulation perfusion, severe peripheral vascular diseases, and/or PVC with unknown etiology;
- •presence of allergic constitution, mental disorder, alcoholism, and/or smoking habit;
- •pregnancy or lactation;
- •ongoing β-blocker treatment or contraindications to β-blocker treatment; -participation in other clinical trials within the prior 3 months;
- •and other reasons for lack of suitability to participate in this study, as determined by the investigators.
研究组 & 干预措施
study group
Metoprolol tartrate (25 mg twice per day, orally) plus TMYXP (40 pills twice per day, orally). the treatment duration is 8 weeks.
干预措施: Tongmai Yangxin Pill (TMYXP) (Drug)
study group
Metoprolol tartrate (25 mg twice per day, orally) plus TMYXP (40 pills twice per day, orally). the treatment duration is 8 weeks.
干预措施: metoprolol tartrate (Drug)
control group
Metoprolol tartrate (25 mg twice per day, orally) plus placebo (40 simulated pills twice per day, orally). The treatment is 8 weeks.
干预措施: metoprolol tartrate (Drug)
control group
Metoprolol tartrate (25 mg twice per day, orally) plus placebo (40 simulated pills twice per day, orally). The treatment is 8 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Effective rate of 24-h number of PVCs after 8-week treatment.
时间窗: 8 weeks
the definition of "effective" is, premature ventricular complex decreased by 50%-70% compared with baseline in the Holter result.
Change in 24-h number of PVCs after 8-week treatment
时间窗: 8 weeks
次要结局
- change in echocardiography parameter E/A(8 weeks)
- total effective rate of comprehensive effect(8 weeks)
- change in high-sensitivity C-reactive protein level(8 weeks)
- change in echocardiography parameter stroke volume(8 weeks)
- change in echocardiography parameter cardiac index(8 weeks)
- change in New York Heart Association (NYHA) classification(8 weeks)
- change in echocardiography parameter left ventricular ejection fraction(8 weeks)
- change in echocardiography parameter left ventricular end diastolic dimension(8 weeks)
- change in echocardiography parameter cardiac output(8 weeks)