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The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02982434
Recruitment Status : Unknown
Verified December 2016 by Meshalkin Research Institute of Pathology of Circulation.
Recruitment status was:  Recruiting
First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

Brief 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 grafting.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Ischemic Heart Disease Drug: Pharmaceutical composition containing botulinum toxin Drug: 0.9% normal saline Procedure: Coronary artery bypass grafting Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Injection of the New Pharmaceutical Composition Containing Botulinum Toxin Into Epicardial Fat Pads to Treat Atrial Fibrillation After Coronary Artery Bypass Grafting
Study Start Date : September 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
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
Drug: Pharmaceutical composition containing botulinum toxin
Procedure: Coronary artery bypass grafting
Active Comparator: Group 2
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
Drug: 0.9% normal saline
Procedure: Coronary artery bypass grafting



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. number of deaths [ Time Frame: 12 month ]
  2. time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU [ Time Frame: 1 month ]
  3. incidence of congestive heart failure [ Time Frame: 12 month ]
  4. incidence of sustained ventricular arrhythmias [ Time Frame: 12 month ]
  5. stroke or transient ischemic attack [ Time Frame: 12 month ]
  6. incidence of myocardial infarction [ Time Frame: 12 month ]
  7. rehospitalization [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02982434


Contacts
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Contact: Alexander Romanov, MD, PhD +73833327655 abromanov@mail.ru
Contact: Evgeny Pokushalov, MD, PhD +73833327655 E.Pokushalov@gmail.com

Locations
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Russian Federation
State Research Institute of Circulation Pathology Recruiting
Novosibirsk, Russian Federation, 630055
Contact: Alexander Romanov, MD, PhD    +73833327655    abromanov@mail.ru   
Contact: Evgeny Pokushalov, MD, PhD    +73833327655    E.Pokushalov@gmail.com   
Cardiology Research Institute Recruiting
Tomsk, Russian Federation
Contact: Boris Kozlov, MD    7(3822) 55 35 96    cardio@cardio-tomsk.ru   
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation

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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02982434    
Other Study ID Numbers: RSTD_021216
First Posted: December 5, 2016    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
atrial fibrillation
botulinum toxin
ischemic heart disease
Additional relevant MeSH terms:
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Atrial Fibrillation
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs