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Effect of botulinum toxin injection versus placebo injection in fat pad around the heart on the incidence of intra-hospital atrial fibrillation after open-heart surgery: a double-blind randomized clinical trial

Effect of botulinum toxin injection versus placebo injection in fat pad around the heart on the incidence of intra-hospital atrial fibrillation after open-heart surgery: a double-blind randomized clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20120215009014N350
Enrollment
60
Registered
2020-03-28
Start date
2020-01-21
Completion date
Unknown
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation. Atrial fibrillation and flutter

Interventions

Intervention 1: Injection of Botulinum Toxin Type A (manufacture by Dysport Pharmaceutical Co.) 50 unit with insulin needle in fat pad around the heart single does. Intervention 2: Control group: Inje

Sponsors

Hamedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age of 18 to 80 years, Indication of open-heart surgery

Exclusion criteria

Exclusion criteria: History of previous hear surgery, Unstable angina or heart failure, Chronic atrial fibrillation, Aortic or mitral valvular disease, Liver or renal or thyroid disorder, Taking anti-arrhythmic medications

Design outcomes

Primary

MeasureTime frame
Intra-hospital atrial fibrillation after open-heart surgery. Timepoint: Daily for 7 to 10 days. Method of measurement: With monitoring machine.;Left ventricular ejection fraction. Timepoint: Before open-heart surgery and one month after that. Method of measurement: Using echocardiography.—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHosna Mohebi

Hamedan University of Medical Sciences

Farzad.imami@umsha.ac.ir+98 81 3838 0572

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026