Back to resultsEfficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex.
Primary Purpose
Premature Ventricular Contraction
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tongmai Yangxin Pill (TMYXP)
metoprolol tartrate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Premature Ventricular Contraction
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
study group
control group
Arm Description
Metoprolol tartrate (25 mg twice per day, orally) plus TMYXP (40 pills twice per day, orally). the treatment duration is 8 weeks.
Metoprolol tartrate (25 mg twice per day, orally) plus placebo (40 simulated pills twice per day, orally). The treatment is 8 weeks.
Outcomes
Primary Outcome Measures
Change in 24-h number of PVCs after 8-week treatment
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.
Secondary Outcome Measures
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.
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%.
change in high-sensitivity C-reactive protein level
change in echocardiography parameter left ventricular ejection fraction
change in echocardiography parameter left ventricular end diastolic dimension
change in echocardiography parameter E/A
change in echocardiography parameter cardiac index
change in echocardiography parameter cardiac output
change in echocardiography parameter stroke volume
Full Information
NCT ID
NCT05008250
First Posted
July 25, 2021
Last Updated
August 9, 2021
Sponsor
Xuanwu Hospital, Beijing
Collaborators
Tianjin Lerentang factory
1. Study Identification
Unique Protocol Identification Number
NCT05008250
Brief Title
Efficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
Tianjin Lerentang factory
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Ventricular Contraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
584 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
Metoprolol tartrate (25 mg twice per day, orally) plus TMYXP (40 pills twice per day, orally). the treatment duration is 8 weeks.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Metoprolol tartrate (25 mg twice per day, orally) plus placebo (40 simulated pills twice per day, orally). The treatment is 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Tongmai Yangxin Pill (TMYXP)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
metoprolol tartrate
Other Intervention Name(s)
metoprolol, betaloc
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
simulated pills
Primary Outcome Measure Information:
Title
Change in 24-h number of PVCs after 8-week treatment
Time Frame
8 weeks
Title
Effective rate of 24-h number of PVCs after 8-week treatment.
Description
the definition of "effective" is, premature ventricular complex decreased by 50%-70% compared with baseline in the Holter result.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
change in New York Heart Association (NYHA) classification
Description
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
Title
total effective rate of comprehensive effect
Description
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
Title
change in high-sensitivity C-reactive protein level
Time Frame
8 weeks
Title
change in echocardiography parameter left ventricular ejection fraction
Time Frame
8 weeks
Title
change in echocardiography parameter left ventricular end diastolic dimension
Time Frame
8 weeks
Title
change in echocardiography parameter E/A
Time Frame
8 weeks
Title
change in echocardiography parameter cardiac index
Time Frame
8 weeks
Title
change in echocardiography parameter cardiac output
Time Frame
8 weeks
Title
change in echocardiography parameter stroke volume
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Hua, PhD
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex.
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