Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery

Atrial Fibrillation New Onset Clinical Trial

Official title:

The Effect of Silymarin on the Prevention of Atrial Fibrillation After Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114719
• Other study ID #: 661-1/1
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2023
• Source: University of Novi Sad
• Contact: Bogdan Okiljevic
• Phone: +381214805702
• Email: bogdanokiljevic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is a prospective, randomized, controlled trial to assess the effects of silymarin on the occurrence of postoperative atrial fibrillation after coronary artery bypass graft surgery.

Description:

Postoperative atrial fibrillation (POAF) is a frequent complication after coronary artery bypass graft (CABG) surgery and is associated with increased mortality. So far, the effects of various drugs and supplements on the occurrence of postoperative atrial fibrillation (POAF) have been studied, but no one has looked into the effect of silymarin on the occurrence of POAF. The study is designed as a prospective, randomized, controlled trial to assess the effects of silymarin on the occurrence of postoperative atrial fibrillation after CABG surgery. A total of 160 patients of both sexes scheduled for elective CABG surgery using cardiopulmonary bypass (CPB) will be included. They will be randomized into two groups (experimental and control) with 80 patients each. Subjects in the experimental group will receive 400 mg of silymarin three days preoperatively, while subjects in the control group will receive standard therapy. The occurrence of POAF after CABG surgery will be the primary outcome, which will be defined as any dysrhythmia that represents the ECG characteristics of atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG. Secondary outcomes will include postoperative values of inflammation markers, length of stay in the ICU, length of hospitalization, and occurrence of postoperative complications (pericardial effusion, stroke, in-hospital death).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• scheduled for elective CABG surgery using cardiopulmonary bypass
• first cardiac surgery
• left ventricular ejection fraction > 35%
• less than moderate mitral regurgitation

Exclusion Criteria:

• preoperative atrial fibrillation
• previous history of interventionally treated arrhythmias
• end-stage renal disease requiring hemodialysis
• chronic inflammatory and neoplastic diseases

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Drug:
• Silymarin
Subjects of the experimental group will receive silymarin (capsules containing 100 mg silymarin, expressed as silibinin) three days preoperatively. The dose they receive will be the recommended dose for the registered indications (400 mg daily, orally, divided into two doses).

Locations

Country	Name	City	State
Serbia	Institute of Cardiovascular Diseases of Vojvodina	Sremska Kamenica

Sponsors (1)

Lead Sponsor	Collaborator
University of Novi Sad

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with postoperative atrial fibrillation	Occurrence of postoperative atrial fibrillation lasting at least 30 s on a rhythm strip or 12-lead ECG	4 days
Secondary	ICU length of stay	Total duration of stay in the intensive care unit	30 days
Secondary	Hospital length of stay	Total duration of stay in hospital	30 days
Secondary	Postoperative complications	Occurrence of postoperative complications including pericardial effusion, stroke, and in-hospital death	30 days
Secondary	Blood concentration of white blood cells	Postoperative values of white blood cells	4 days
Secondary	Blood concentration of C-reactive protein	Postoperative values of C-reactive protein	4 days