Atrial FibrillationPhase 2NCT02982434
The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation
A Phase 2 study testing Pharmaceutical composition containing botulinum toxin, 0.9% normal saline and Coronary artery bypass grafting in people with Atrial Fibrillation and Ischemic Heart Disease, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in Russia.
Trial summary
The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Ischemic Heart Disease
- What is being tested?
- Pharmaceutical composition containing botulinum toxin, 0.9% normal saline and Coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesRussia
- Study dates
- Sep 2016to Feb 2018
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with paroxysmal AF (recurrent episodes for at least 2 years, with ≥ 6 episodes over the last 6 months)
- At least one failed antiarrhythmic drug
- Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery
Who cannot join
- Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation or atrial fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation Unwillingness to participate
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
State Research Institute of Circulation Pathology
Novosibirsk, 630055
Alexander Romanov, MD, PhD, +73833327655, abromanov@mail.ru
Evgeny Pokushalov, MD, PhD, +73833327655, E.Pokushalov@gmail.com
- Recruiting
Cardiology Research Institute
Tomsk
Boris Kozlov, MD, 7(3822) 55 35 96, cardio@cardio-tomsk.ru
About this study
Official title: Injection of the New Pharmaceutical Composition Containing Botulinum Toxin Into Epicardial Fat Pads to Treat Atrial Fibrillation After Coronary Artery Bypass Grafting
The aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.
- Conditions
- Atrial Fibrillation, Ischemic Heart Disease
- Being tested
- Pharmaceutical composition containing botulinum toxin, 0.9% normal saline, Coronary artery bypass grafting
- Keywords
- atrial fibrillation, botulinum toxin, ischemic heart disease
- Medical subject headings
- Atrial Fibrillation, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaceutical composition containing botulinum toxinDrug
0.9% normal salineDrug
Coronary artery bypass graftingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | All patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP Receives: Drug: Pharmaceutical composition containing botulinum toxin; Procedure: Coronary artery bypass grafting |
| Group 2 | Active comparator | All patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP Receives: Drug: 0.9% normal saline; Procedure: Coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from any atrial tachyarrhythmias
Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
Measured: 12 months
Secondary outcomes (7)
number of deaths
Measured: 12 month
time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU
Measured: 1 month
incidence of congestive heart failure
Measured: 12 month
incidence of sustained ventricular arrhythmias
Measured: 12 month
stroke or transient ischemic attack
Measured: 12 month
incidence of myocardial infarction
Measured: 12 month
rehospitalization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982434
- Sponsor's protocol ID
- RSTD_021216
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection of the New Pharmaceutical Composition Containing Botulinum Toxin Into Epicardial Fat Pads to Treat Atrial Fibrillation After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT02982434
- Acronym / sponsor ID
- RSTD_021216
- Conditions
- Atrial Fibrillation, Ischemic Heart Disease
- Keywords
- atrial fibrillation, botulinum toxin, ischemic heart disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Sep 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 5 Dec 2016 (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 aim of this prospective randomized double-blind study was to compare the efficacy of new pharmaceutical composition containing botulinum toxin injection in epicardial fat pads for preventing recurrences of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Pharmaceutical composition containing botulinum toxin, Procedure: Coronary artery bypass graftingAll patients underwent conventional CABG surgery. After the main stage of the surgery new pharmaceutical composition containing botulinum toxin (50 U/1 mL) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right ganglionated plexi (GP); second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior pulmonary vein (PV) and left inferior PV (between the PVs and left atrial appendage (LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP |
| Group 2 | Active comparator | Drug: 0.9% normal saline, Procedure: Coronary artery bypass graftingAll patients underwent conventional cardiac surgery. After the main stage of the surgery 0.9% normal saline (1 mL at each fat pad) was injected into the entire four visible area of the major epicardial fat pads. First epicardial left atrial fat pad is located anterior to the right superior pulmonary vein and corresponding to the anterior right GP; second epicardial fat pad is located inferoposterior to the right inferior pulmonary vein and corresponding to the inferior right GP; third fat pad is located anterior to the left superior PV and left inferior PV (between the PVs and LAA), corresponding to the Marshall tract GP and superior left GP; forth fat pad located inferiorly to the left inferior PV and extends posteriorly and corresponding to the inferior left GP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with paroxysmal AF (recurrent episodes for at least 2 years, with ≥ 6 episodes over the last 6 months)
- At least one failed antiarrhythmic drug
- Indication for cardiac surgery (e.g. coronary artery bypass grafting, valve repair/replacement) according to the American College of Cardiology/American Heart Association (ACC/AHA) guidelines for cardiac surgery
Key exclusion criteria (1 listed)
- Previous heart surgery or atrial fibrillation ablation procedure Emergency coronary artery bypass grafting Unstable angina or heart failure Persistent atrial fibrillation or atrial fibrillation at the time of screening Planned maze procedure or pulmonary vein isolation Unwillingness to participate
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 |
|---|---|---|
| Pharmaceutical composition containing botulinum toxin | Drug | Group 1 |
| 0.9% normal saline | Drug | Group 2 |
| Coronary artery bypass grafting | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Freedom from any atrial tachyarrhythmias
Time frame: 12 months
Recurrence of >30 s of any atrial tachyarrhythmia, including atrial fibrillation and atrial flutter/tachycardia, after cardiac surgery procedure with no antiarrhythmic drug
7 secondary outcomes
number of deaths
Time frame: 12 month
time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU
Time frame: 1 month
incidence of congestive heart failure
Time frame: 12 month
incidence of sustained ventricular arrhythmias
Time frame: 12 month
stroke or transient ischemic attack
Time frame: 12 month
incidence of myocardial infarction
Time frame: 12 month
rehospitalization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pharmaceutical composition containing botulinum toxin, 0.9% normal saline and Coronary artery bypass grafting in people with Atrial Fibrillation and Ischemic Heart Disease, run by Meshalkin Research Institute of Pathology of Circulation at 2 sites in Russia.
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 1 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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Alexander Romanov, MD, PhD (+73833327655, abromanov@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from any atrial tachyarrhythmias (time frame: 12 months). 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 5 Dec 2016.