Efficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex.
- Conditions
- Premature Ventricular Contraction
- Interventions
- Registration Number
- NCT05008250
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 584
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group Tongmai Yangxin Pill (TMYXP) Metoprolol tartrate (25 mg twice per day, orally) plus TMYXP (40 pills twice per day, orally). the treatment duration is 8 weeks. control group placebo Metoprolol tartrate (25 mg twice per day, orally) plus placebo (40 simulated pills twice per day, orally). The treatment is 8 weeks. control group metoprolol tartrate Metoprolol tartrate (25 mg twice per day, orally) plus placebo (40 simulated pills twice per day, orally). The treatment is 8 weeks. study group metoprolol tartrate Metoprolol tartrate (25 mg twice per day, orally) plus TMYXP (40 pills twice per day, orally). the treatment duration is 8 weeks.
- Primary Outcome Measures
Name Time Method Effective rate of 24-h number of PVCs after 8-week treatment. 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 8 weeks
- Secondary Outcome Measures
Name Time Method total effective rate of comprehensive effect 8 weeks Total effective rate of comprehensive effect was defined as total symptom score; clinical recovery was defined as significant improvement of clinical symptoms and reduction of symptom score by ≥90%.
change in high-sensitivity C-reactive protein level 8 weeks change in echocardiography parameter E/A 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 Marked effective NYHA improvement was defined as reduction of NYHA grade by ≥2; effective NYHA improvement was defined as reduction of NYHA grade by 1; non-effective NYHA improvement was defined as no change or elevation of NYHA grade.
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