The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation

NCT02982434 | Unknown Phase 2

• 1 other identifier: RSTD_021216
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation; Ischemic Heart Disease

Keywords

atrial fibrillation; botulinum toxin; ischemic heart disease

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (7)

• number of deaths

  12 month

• time intervals from end of surgery to weaning from ventilation, extubation and discharge from ICU

  1 month

• incidence of congestive heart failure

  12 month

• incidence of sustained ventricular arrhythmias

  12 month

• stroke or transient ischemic attack

  12 month

Study Arms (2)

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

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

Drug: 0.9% normal saline; Procedure: Coronary artery bypass grafting

Interventions

Pharmaceutical composition containing botulinum toxin DRUG

Group 1

0.9% normal saline DRUG

Group 2

Coronary artery bypass grafting PROCEDURE

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (2)

State Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

RECRUITING

Cardiology Research Institute

Tomsk, Russia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Myocardial Ischemia

Interventions

Saline Solution; Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Alexander Romanov, MD, PhD

CONTACT

+73833327655; abromanov@mail.ru

Evgeny Pokushalov, MD, PhD

CONTACT

+73833327655; E.Pokushalov@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

RU (2)