Clinical trial NCT05008250: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premature Ventricular Contraction
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Tianjin Lerentang factory
First posted: 2021-08-17
Enrollment: 584
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change in 24-h number of PVCs after 8-week treatment
timeFrame: 8 weeks
measure: Effective rate of 24-h number of PVCs after 8-week treatment.
timeFrame: 8 weeks
Secondary outcomes:
measure: change in New York Heart Association (NYHA) classification
timeFrame: 8 weeks
measure: total effective rate of comprehensive effect
timeFrame: 8 weeks
measure: change in high-sensitivity C-reactive protein level
timeFrame: 8 weeks
measure: change in echocardiography parameter left ventricular ejection fraction
timeFrame: 8 weeks
measure: change in echocardiography parameter left ventricular end diastolic dimension
timeFrame: 8 weeks
measure: change in echocardiography parameter E/A
timeFrame: 8 weeks
measure: change in echocardiography parameter cardiac index
timeFrame: 8 weeks
measure: change in echocardiography parameter cardiac output
timeFrame: 8 weeks
measure: change in echocardiography parameter stroke volume
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Qi Hua, PhD
role: PRINCIPAL_INVESTIGATOR
References: