Premature Ventricular ContractionPhase 4SS-SBVPTNCT01750775
Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions
A Phase 4 study testing Shensong Yangxin capsule in people with Premature Ventricular Contraction, run by kejiang Cao at 1 site in China.
Trial summary
The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Premature Ventricular Contraction
- What is being tested?
- Shensong Yangxin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Dec 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years to 70 Years old
- Documented sinus bradycardia with average heart rate at 45-59 by 24hours ambulatory EKG
- Ventricular premature beats: >1000 beats/24 hours
Who cannot join
- Younger than 18 years or older than 75 years
- Symptomatic sinus arrest >3 seconds or high degree atrioventricular block indicated for pacemaker
- Subject suffered from acute coronary syndrome in last three months (Acute myocardial infarction of ST segment elevation and non ST segment elevation, unstable angina
- To be complicated with persistent atrial fibrillation, or paroxysmal atrial fibrillation >5% during 24hrs ambulatory EKG or acute myocarditis
- To be complicated with ventricular fibrillation, torsion type ventricular heartbeat rate, sustained ventricular tachycardia, or non sustained ventricular tachycardia with rapid ventricular rate and hemodynamic disorders
- Sinus heart rate less than 45 beats/minutes and needs to receive the pacemaker or has received pacemaker, or with ICD,CRTP/D
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical Universtiy
Nanjing, Jiangsu
About this study
Official title: Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions Multi-center,Randomized, Double-blind, Placebo-controlled Clinical Study
The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats.
Read the detailed description
Premature ventricular contractions is one of the most common symptomatic arrhythmia. Antiarrhythmia drugs for premature ventricular contractions, such as beta-blockers and sodium channel blockers, can cause bradycardia. For sinus bradycardia patients complicated with premature ventricular contractions, it's hard for doctors to make decision. The purpose of the study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats, which based on the numbers of premature ventricular contractions and average hear rate in 24-hour ambulatory electrocardiogram (ECG) after 8 weeks treatment as the primary endpoint of the study. Secondary endpoints are evaluation of the Shensong Yangxin capsule on quality of life. This study is a randomized, double-blind, placebo controlled, multi-center trial. Sinus bradycardia patients(average heart rate 45-59 beat per minute) associated with premature ventricular contractions (PVC number >10000 / 24h), are involved in the study. Patients are randomly assigned into Shensong Yangxin capsule group or placebo group, with the capsule administration of 4 granules t.i.d.for 8 weeks. 24-hour ambulatory ECG, are observed at baseline,4 weeks and 8 weeks after the intervention. The primary outcomes are the numbers of premature ventricular contractions and average heat rate in 24-hour ambulatory ECG, and the secondary outcomes is Minnesota living with heart failure questionnaire (MLHFQ).
- Conditions
- Premature Ventricular Contraction
- Being tested
- Shensong Yangxin capsule, placebo Capsule
- Keywords
- sinus bradycardia, ventricular premature contraction
- 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.
Shensong Yangxin capsuleDrug
ShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks
placebo CapsuleDrug
placebo Capsule 4 granules t.i.d. by mouth for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Shensong Yangxin capsule | Experimental | Shensong Yangxin capsule 4 granules t.i.d. by mouth for 8weeks Receives: Drug: Shensong Yangxin capsule |
| placebo Capsule | Placebo comparator | placebo Capsule 4 granules t.i.d. by mouth for 8 weeks Receives: Drug: placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG
Measured: 8 weeks
average heart rate detected by 24-hour ambulatory ECG
Measured: 8 weeks
Secondary outcomes (2)
numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG
Measured: 4 weeks
average heart rate detected by 24-hour ambulatory ECG
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startAug 2012
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature Ventricular ContractionStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- kejiang Cao
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Third Military Medical University
- Responsible party
- Sponsor-investigator, kejiang Cao, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Kejiang Cao, M.D, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750775
- Sponsor's protocol ID
- yl-yxb07-lcsyfa-201202
- Other IDs
- ChiCTR-TRC-12002504
- Acronym
- SS-SBVPT
- Status last verified
- Dec 2012
- First submitted
- 6 Dec 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang F, Zou J, Yu H, Li X, Kojodjojo P, Cai X, Zhang S, Huang C, Hong K, Yu B, Li G, Luo S, Zhou S, Zheng Y, Fan J, Cao X, Tao G, Sheng G, Bai Z, Jiang S, Liu X, Gu W, Chen F, Cao K. Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial. Evid Based Complement Alternat Med. 2019 Mar 4;2019:3917282. doi: 10.1155/2019/3917282. eCollection 2019.
PubMed 30949218
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shensongyangxin Capsule in the Treatment of Sinus Bradycardia With Premature Ventricular Contractions Multi-center,Randomized, Double-blind, Placebo-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT01750775
- Acronym / sponsor ID
- SS-SBVPT / yl-yxb07-lcsyfa-201202
- Conditions
- Premature Ventricular Contraction
- Keywords
- sinus bradycardia, ventricular premature contraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- kejiang CaoUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital, Third Military Medical University
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 Dec 2012 (estimated)
- 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.
The purpose of this study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats.
Detailed description
Premature ventricular contractions is one of the most common symptomatic arrhythmia. Antiarrhythmia drugs for premature ventricular contractions, such as beta-blockers and sodium channel blockers, can cause bradycardia. For sinus bradycardia patients complicated with premature ventricular contractions, it's hard for doctors to make decision. The purpose of the study is to assess the effects of Chinese medicine Shansong Yangxin capsule for sinus bradycardia complicated with ventricular premature beats, which based on the numbers of premature ventricular contractions and average hear rate in 24-hour ambulatory electrocardiogram (ECG) after 8 weeks treatment as the primary endpoint of the study. Secondary endpoints are evaluation of the Shensong Yangxin capsule on quality of life. This study is a randomized, double-blind, placebo controlled, multi-center trial. Sinus bradycardia patients(average heart rate 45-59 beat per minute) associated with premature ventricular contractions (PVC number >10000 / 24h), are involved in the study. Patients are randomly assigned into Shensong Yangxin capsule group or placebo group, with the capsule administration of 4 granules t.i.d.for 8 weeks. 24-hour ambulatory ECG, are observed at baseline,4 weeks and 8 weeks after the intervention. The primary outcomes are the numbers of premature ventricular contractions and average heat rate in 24-hour ambulatory ECG, and the secondary outcomes is Minnesota living with heart failure questionnaire (MLHFQ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shensong Yangxin capsule | Experimental | Drug: Shensong Yangxin capsuleShensong Yangxin capsule 4 granules t.i.d. by mouth for 8weeks |
| placebo Capsule | Placebo comparator | Drug: placebo Capsuleplacebo Capsule 4 granules t.i.d. by mouth for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 Years to 70 Years old
- Documented sinus bradycardia with average heart rate at 45-59 by 24hours ambulatory EKG
- Ventricular premature beats: >1000 beats/24 hours
Key exclusion criteria (6 listed)
- Younger than 18 years or older than 75 years
- Symptomatic sinus arrest >3 seconds or high degree atrioventricular block indicated for pacemaker
- Subject suffered from acute coronary syndrome in last three months (Acute myocardial infarction of ST segment elevation and non ST segment elevation, unstable angina
- To be complicated with persistent atrial fibrillation, or paroxysmal atrial fibrillation >5% during 24hrs ambulatory EKG or acute myocarditis
- To be complicated with ventricular fibrillation, torsion type ventricular heartbeat rate, sustained ventricular tachycardia, or non sustained ventricular tachycardia with rapid ventricular rate and hemodynamic disorders
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 |
|---|---|---|
| Shensong Yangxin capsuleShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks | Drug | Shensong Yangxin capsule |
| placebo Capsuleplacebo Capsule 4 granules t.i.d. by mouth for 8 weeks | Drug | placebo Capsule |
Primary outcome
numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG
Time frame: 8 weeks
average heart rate detected by 24-hour ambulatory ECG
Time frame: 8 weeks
2 secondary outcomes
numbers of the Premature ventricular contractions detected by 24-hour ambulatory ECG
Time frame: 4 weeks
average heart rate detected by 24-hour ambulatory ECG
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2012.
- Derived from this study: PubMed 30949218Zhang F, Zou J, Yu H, Li X, Kojodjojo P, Cai X, Zhang S, Huang C, Hong K, Yu B, Li G, Luo S, Zhou S, Zheng Y, Fan J, Cao X, Tao G, Sheng G, Bai Z, Jiang S, Liu X, Gu W, Chen F, Cao K. Acute Efficacy of a Traditional Chinese Medicine for Treatment of Frequent Premature Ventricular Contractions in Patients with Concomitant Sinus Bradycardia: Results from a Double-Blind, Placebo-Controlled, Multicentre, Randomized Clinical Trial. Evid Based Complement Alternat Med. 2019 Mar 4;2019:3917282. doi: 10.1155/2019/3917282. eCollection 2019.
Related trials for Premature Ventricular Contraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)
Recruiting
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes
Premature Ventricular Complexes, Premature Ventricular Contraction (PVC)
Enrolling by invitation
Treatment of Focal Ventricular Tachycardias Using a Pulsed Field Ablation From a Point Ablation Catheter Short Title FOCUS-PFA
Focal Ventricular Arrhythmias, Premature Ventricular Contractions
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.
Kejiang Cao, M.D principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shensong Yangxin capsule in people with Premature Ventricular Contraction, run by kejiang Cao at 1 site in China.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 17 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
numbers of the Premature ventricular contractions detected by 24 houres ambulatory EKG (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?
On the ClinicalTrials.gov record for NCT01750775, which also lists 1 linked publication.
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 Dec 2012; AzTrials last refreshed its copy on 8 Nov 2026.