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Completed

NCT Number: NCT05008250

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

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).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Treatment and study plan

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.

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.

Other names: metoprolol, betaloc

Placebo

Drug

simulated pills

Primary outcomes

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

    Time frame: 8 weeks

  2. Effective rate of 24-h number of PVCs after 8-week treatment.

    Time frame: 8 weeks

    the definition of "effective" is, premature ventricular complex decreased by 50%-70% compared with baseline in the Holter result.

Secondary outcomes

  1. change in New York Heart Association (NYHA) classification

    Time frame: 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.

  2. total effective rate of comprehensive effect

    Time frame: 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%.

  3. change in high-sensitivity C-reactive protein level

    Time frame: 8 weeks

  4. change in echocardiography parameter left ventricular ejection fraction

    Time frame: 8 weeks

  5. change in echocardiography parameter left ventricular end diastolic dimension

    Time frame: 8 weeks

  6. change in echocardiography parameter E/A

    Time frame: 8 weeks

  7. change in echocardiography parameter cardiac index

    Time frame: 8 weeks

  8. change in echocardiography parameter cardiac output

    Time frame: 8 weeks

  9. change in echocardiography parameter stroke volume

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Tianjin Lerentang factory

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 17, 2021
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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