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

NCT05008250 | Completed Phase 4

• 1 other identifier: 2013019
• Study Type: interventional
• Target: 584
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Premature Ventricular Contraction

Outcome Measures

Primary Outcomes (2)

• Change in 24-h number of PVCs after 8-week treatment

  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.

  8 weeks

Secondary Outcomes (9)

• change in New York Heart Association (NYHA) classification

  8 weeks

• total effective rate of comprehensive effect

  8 weeks

• change in high-sensitivity C-reactive protein level

  8 weeks

• change in echocardiography parameter left ventricular ejection fraction

  8 weeks

• change in echocardiography parameter left ventricular end diastolic dimension

  8 weeks

Study Arms (2)

study group

EXPERIMENTAL

Metoprolol tartrate (25 mg twice per day, orally) plus TMYXP (40 pills twice per day, orally). the treatment duration is 8 weeks.

Drug: Tongmai Yangxin Pill (TMYXP); Drug: metoprolol tartrate

control group

PLACEBO COMPARATOR

Metoprolol tartrate (25 mg twice per day, orally) plus placebo (40 simulated pills twice per day, orally). The treatment is 8 weeks.

Drug: metoprolol tartrate; Drug: placebo

Interventions

Tongmai Yangxin Pill (TMYXP) DRUG

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.

study group

metoprolol tartrate DRUG

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.

Also known as: metoprolol, betaloc

control group; study group

placebo DRUG

simulated pills

control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Tianjin Lerentang factory: collaborator

MeSH Terms

Conditions

Ventricular Premature Complexes

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Qi Hua, PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 17, 2021
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 17, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share