Premature Ventricular ContractionPhase 4NCT05008250
Efficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex.
A Phase 4 study testing Tongmai Yangxin Pill (TMYXP) and metoprolol tartrate in people with Premature Ventricular Contraction, run by Xuanwu Hospital, Beijing.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Premature Ventricular Contraction
- What is being tested?
- Tongmai Yangxin Pill (TMYXP) and metoprolol tartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 584 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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.
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.
Read more
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
- Being tested
- Tongmai Yangxin Pill (TMYXP), metoprolol tartrate, placebo
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 tartrateDrug
Also called metoprolol, betaloc
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.
placeboDrug
simulated pills
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: metoprolol tartrate; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-h number of PVCs after 8-week treatment
Measured: 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.
Measured: 8 weeks
Secondary outcomes (9)
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.
Measured: 8 weeks
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%.
Measured: 8 weeks
change in high-sensitivity C-reactive protein level
Measured: 8 weeks
change in echocardiography parameter left ventricular ejection fraction
Measured: 8 weeks
change in echocardiography parameter left ventricular end diastolic dimension
Measured: 8 weeks
change in echocardiography parameter E/A
Measured: 8 weeks
change in echocardiography parameter cardiac index
Measured: 8 weeks
change in echocardiography parameter cardiac output
Measured: 8 weeks
change in echocardiography parameter stroke volume
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study startJan 2014
- Primary completionAug 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ContractionStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Lerentang factory
- Responsible party
- Sponsor
- Investigators
- Qi Hua, PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008250
- Sponsor's protocol ID
- 2013019
- Status last verified
- Jul 2021
- First submitted
- 25 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05008250
- Acronym / sponsor ID
- 2013019
- Conditions
- Premature Ventricular Contraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Tianjin Lerentang factory
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Tongmai Yangxin Pill (TMYXP), Drug: metoprolol tartrateMetoprolol tartrate (25 mg twice per day, orally) plus TMYXP (40 pills twice per day, orally). the treatment duration is 8 weeks. |
| control group | Placebo comparator | Drug: metoprolol tartrate, Drug: placeboMetoprolol tartrate (25 mg twice per day, orally) plus placebo (40 simulated pills twice per day, orally). The treatment is 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 β-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction. | Drug | study group |
| metoprolol tartrateAlso: metoprolol, betalocmetoprolol 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. | Drug | control group, study group |
| placebosimulated pills | Drug | control group |
Primary outcome
Change in 24-h number of PVCs after 8-week treatment
Time frame: 8 weeks
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.
9 secondary outcomes
change in New York Heart Association (NYHA) classification
Time frame: 8 weeks
total effective rate of comprehensive effect
Time frame: 8 weeks
change in high-sensitivity C-reactive protein level
Time frame: 8 weeks
change in echocardiography parameter left ventricular ejection fraction
Time frame: 8 weeks
change in echocardiography parameter left ventricular end diastolic dimension
Time frame: 8 weeks
change in echocardiography parameter E/A
Time frame: 8 weeks
change in echocardiography parameter cardiac index
Time frame: 8 weeks
change in echocardiography parameter cardiac output
Time frame: 8 weeks
change in echocardiography parameter stroke volume
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Hua, PhD principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tongmai Yangxin Pill (TMYXP) and metoprolol tartrate in people with Premature Ventricular Contraction, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-h number of PVCs after 8-week treatment (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.