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Clinical research protocol on colchicine improving the maintenance rate of sinus rhythm after surgical radiofrequency ablation (Cox-Maze IV) in permanent atrial fibrillation

Clinical research protocol on colchicine improving the maintenance rate of sinus rhythm after surgical radiofrequency ablation (Cox-Maze IV) in permanent atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107706
Enrollment
Unknown
Registered
2025-08-18
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

atrial fibrillation

Interventions

Colchicine group:Take colchicine orally, 0.5mg per day, once a day, for a total of three months
Amiodarone group:Amiodarone group 200mg per day, once a day, for three consecutive months
Placebo group:Take an oral placebo, one tablet per day, once a day, for a total of three months.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who underwent extracorporeal circulation heart surgery at West China Hospital of Sichuan University; 2. Patients diagnosed with rheumatic valvular disease combined with permanent atrial fibrillation, requiring mitral valve surgery (mitral valve reconstruction or mitral valve replacement) or/and aortic valve replacement or/and tricuspid valve surgery (tricuspid valve reconstruction or tricuspid valve replacement), and agreeing to surgical ablation of atrial fibrillation; 3. Age >= 18 years, <= 80 years, gender not limited; 4. Signed informed consent form; 5. New York Heart Association (NYHA) functional classification: I-II grade. 6. Grouping: Colchicine group, Tadalafil group, placebo group. Oral colchicine, 0.5 mg per day, once a day, for 3 consecutive months. Tadalafil group, 200 mg per day, once a day, for 3 consecutive months. Placebo group, oral placebo, 1 tablet per day, once a day, for 3 consecutive months. 7. The drugs are free of charge and paid for by the project funds (National Natural Science Foundation of China, Hospital Project 135), as ultrasound, electrocardiogram, blood sampling and other tests are already routine postoperative follow-ups and do not involve compensation

Exclusion criteria

Exclusion criteria: 1. Patients with paroxysmal atrial fibrillation; 2. Anterior-posterior diameter of the left atrium > 70mm; 3. Complicated with coronary heart disease and requiring concurrent coronary artery bypass grafting surgery; 4. History of internal medical intervention or surgical ablation for atrial fibrillation, and previous history of cardiac surgery; Surgical treatment for hypertrophic obstructive cardiomyopathy; Severe chronic obstructive pulmonary disease (FEV1 3% by EuroScore II in European cardiovascular surgery assessment; 9. Patients requiring secondary surgery; 10. Immune diseases; 11. Long-term oral administration of hormone drugs; 12. History of malignant tumors or infectious diseases; 13. Allergic or intolerant to colchicine.

Design outcomes

Primary

MeasureTime frame
Sinus rhythm maintenance rate;

Secondary

MeasureTime frame
cardiac function;Venous inflammatory markers;

Countries

China

Contacts

Public ContactZhong Wu

Department of Cardiovascular Surgery, West China Hospital, Sichuan University

wuzhong71@scu.edu.cn+86 189 8060 6048

Outcome results

None listed

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