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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
584
TMYXP is a Chinese patent medicine developed by many years of clinical practice experience. The ingredients of TMYXP are Radix Rehmanniae, Caulis Spatholobi, Polygonum Multiflorum, Colla Corii Asini, Ophiopogonis, Tortoise Shell (vinegar), Radix Codonopsis, Cassia Twig, Jujube, Schisandra Fruit, and Licorice Root. It has the effect of invigorating Qi, nourishing Yin, dredging the pulse, and relieving pain. It is used in treatment of Qi and Yin deficiency syndromes caused by coronary heart disease, angina pectoris, and arrhythmia. Metoprolol tartrate (a heart-selective β-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction.
metoprolol tartrate (a heart-selective β-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction.
simulated pills
Change in 24-h number of PVCs after 8-week treatment
Time frame: 8 weeks
Effective rate of 24-h number of PVCs after 8-week treatment.
the definition of "effective" is, premature ventricular complex decreased by 50%-70% compared with baseline in the Holter result.
Time frame: 8 weeks
change in New York Heart Association (NYHA) classification
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.
Time frame: 8 weeks
total effective rate of comprehensive effect
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%.
Time frame: 8 weeks
change in high-sensitivity C-reactive protein level
Time frame: 8 weeks
change in echocardiography parameter left ventricular ejection fraction
Time frame: 8 weeks
change in echocardiography parameter left ventricular end diastolic dimension
Time frame: 8 weeks
change in echocardiography parameter E/A
Time frame: 8 weeks
change in echocardiography parameter cardiac index
Time frame: 8 weeks
change in echocardiography parameter cardiac output
Time frame: 8 weeks
change in echocardiography parameter stroke volume
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.