Investigating colchicine for treating atrial fibrillation
The Colchicine and Atrial Fibrillation Trial
This study is testing whether a low dose of colchicine can help prevent atrial fibrillation from coming back in people who have had successful heart rhythm treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Hellerup) |
| Trial ID | NCT05928728 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of colchicine on the recurrence of atrial fibrillation (AF) and its impact on vascular and cardiac function. It is a phase 3, double-blind, placebo-controlled study involving approximately 500 patients aged 18 and older who have paroxysmal or persistent AF and have undergone successful cardioversion. Participants will be randomly assigned to receive either low-dose colchicine or a placebo for 12 months, with assessments conducted through ECG, echocardiography, cardiac MRI, and blood samples at baseline and after 6 and 12 months.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with paroxysmal or persistent atrial fibrillation who are undergoing cardioversion.
Not a fit: Patients currently receiving colchicine treatment or those with contraindications to colchicine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to reduce AF recurrence and improve cardiac health.
How similar studies have performed: While colchicine has been studied in other contexts, this specific application for atrial fibrillation is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Living address in the Capital Region of Denmark 2. Age \> 18 3. Diagnosed with paroxysmic/persistent AF. 4. Planned or acute admission for cardioversion of AF with successful outcome. 5. Female participants should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device 6. Participants will have given written, informed consent and are able and willing to comply with the requirements of the study protocol. 7. Optimal background therapy (in relation to comorbidities and development of heart failure / thromboembolic event) for AF as judged by the investigator. Exclusion Criteria: 1. Colchicine treatment for another cause, e.g. gout 2. Allergy/hypersensitivity to colchicine 3. Uncontrolled hypertension (systolic BP \>180 mmHg or diastolic BP \>110 mmHg) 4. History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix 5. Cirrhosis, chronic active hepatitis or other severe hepatic disease 6. Hemodialysis 7. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 8. Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1) 9. Permanent AF 10. Female participants who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion 11. Significant drug or alcohol abuse during the last year 12. Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed) 13. Planned ablation procedure as treatment for AF 14. If cardiovascular surgery or ablation has been done the past three months prior to inclusion. 15. Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea 16. Use of other investigational drugs within 30 days of the time of enrollment 17. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study. 18. Suspected AF, confirmed with ECG, at time of inclusion and randomization
Where this trial is running
Hellerup
- Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) — Hellerup, Denmark (Recruiting)
Study contacts
- Principal investigator: Adam Femerling Langhoff, M.D. — Herlev and Gentofte Hospital
- Study coordinator: Adam Femerling Langhoff, M.D.
- Email: adam.femerling.langhoff@regionh.dk
- Phone: +4522552317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.