Efficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex.

Premature Ventricular Contraction Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008250
• Other study ID #: 2013019
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2021
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 ß-blocker treatment or contraindications to ß-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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Ventricular Contraction
• Ventricular Premature Complexes

Intervention

Drug:
• Tongmai Yangxin Pill (TMYXP)
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 ß-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction.
• metoprolol tartrate
metoprolol tartrate (a heart-selective ß-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction.
• placebo
simulated pills

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	Tianjin Lerentang factory

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-h number of PVCs after 8-week treatment		8 weeks
Primary	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.	8 weeks
Secondary	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.	8 weeks
Secondary	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%.	8 weeks
Secondary	change in high-sensitivity C-reactive protein level		8 weeks
Secondary	change in echocardiography parameter left ventricular ejection fraction		8 weeks
Secondary	change in echocardiography parameter left ventricular end diastolic dimension		8 weeks
Secondary	change in echocardiography parameter E/A		8 weeks
Secondary	change in echocardiography parameter cardiac index		8 weeks
Secondary	change in echocardiography parameter cardiac output		8 weeks
Secondary	change in echocardiography parameter stroke volume		8 weeks