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The COLchicine and Atrial FIBrillation Trial (COLFIB)

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Living address in the Capital Region of Denmark Age > 18 Diagnosed with paroxysmic/persistent AF. Planned or acute admission for cardioversion of AF with successful outcome. 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 Participants will have given written, informed consent and are able and willing to comply with the requirements of the study protocol. Optimal background therapy (in relation to comorbidities and development of heart failure / thromboembolic event) for AF as judged by the investigator. Exclusion Criteria: Colchicine treatment for another cause, e.g. gout Allergy/hypersensitivity to colchicine Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg) 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 Cirrhosis, chronic active hepatitis or other severe hepatic disease Hemodialysis Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1) Permanent AF Female participants who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion Significant drug or alcohol abuse during the last year Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed) Planned ablation procedure as treatment for AF If cardiovascular surgery or ablation has been done the past three months prior to inclusion. Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea Use of other investigational drugs within 30 days of the time of enrollment 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. Suspected AF, confirmed with ECG, at time of inclusion and randomization

Sites / Locations

  • Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Between-group difference in change in time to first AF admission measured in days

Secondary Outcome Measures

Between-group difference in change in accumulated number of readmissions for symptomatic AF
Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography
Between-group difference in change in Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) score
Score of 0 being the worst outcome and score of 100 being the best outcome

Full Information

First Posted
June 14, 2023
Last Updated
June 23, 2023
Sponsor
Herlev and Gentofte Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05928728
Brief Title
The COLchicine and Atrial FIBrillation Trial
Acronym
COLFIB
Official Title
The Colchicine and Atrial Fibrillation Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
June 14, 2024 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev and Gentofte Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study to investigate the effects of colchicine on atrial fibrillation recurrence and vascular and cardiac function in patients with atrial fibrillation.
Detailed Description
The study is an investigator-initiated, prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effects of colchicine in patients with atrial fibrillation (AF). The study population will consist of approximately 500 patients aged 18 years and above with a diagnosis of paroxysmic or persistent AF with a successful outcome of cardioversion. Patients will be randomized to either low-dose colchicine treatment (0,5 mg once daily) or placebo. Treatment will continue for 12 months. Patients will be assessed by measurement of time to first admission with AF (Electro Cardio Gram (ECG) confirmed), echocardiography, cardiac Magnetic Resonance Imaging (MRI), and blood samples at baseline and after 6 + 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colchicine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Colchicine 0.5 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily
Primary Outcome Measure Information:
Title
Between-group difference in change in time to first AF admission measured in days
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Between-group difference in change in accumulated number of readmissions for symptomatic AF
Time Frame
12 months
Title
Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) score
Description
Score of 0 being the worst outcome and score of 100 being the best outcome
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Between-group difference in change in plasma concentration of high sensitivity C-Reactive Protein (hs-CRP)
Time Frame
12 months
Title
Between-group difference in change in plasma concentration of high sensitivity Troponin I (hs-TnI)
Time Frame
12 months
Title
Between-group difference in change in Left Ventricle (LV) septal wall thickness assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in LV mass index assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in LV posterior wall thickness assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in Left Ventricle Ejection Fraction (LVEF) assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in E/A ratio assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in e' assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in E/e' ratio assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in Global Longitudinal Strain (GLS) assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in aortic distensibility assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in aortic strain assessed by echocardiography
Time Frame
12 months
Title
Between-group difference in change in LV septal wall thickness assessed by cardiac MRI
Time Frame
12 months
Title
Between-group difference in change in LV posterior wall thickness assessed by cardiac MRI
Time Frame
12 months
Title
Between-group difference in change in LVEF assessed by cardiac MRI
Time Frame
12 months
Title
Between-group difference in change in myocardial fibrosis assessed by cardiac MRI
Time Frame
12 months
Title
Between-group difference in change in myocardial inflammation assessed by cardiac MRI
Time Frame
12 months
Title
Between-group difference in change in plasma concentration of Tumor Necrosis Factor alpha (TNF-α)
Time Frame
12 months
Title
Between-group difference in change in plasma concentration of pro Brain Natriuretic Peptide (pro-BNP)
Time Frame
12 months
Title
Between-group difference in change in accumulated number of cardiovascular-related hospital visits
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Living address in the Capital Region of Denmark Age > 18 Diagnosed with paroxysmic/persistent AF. Planned or acute admission for cardioversion of AF with successful outcome. 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 Participants will have given written, informed consent and are able and willing to comply with the requirements of the study protocol. Optimal background therapy (in relation to comorbidities and development of heart failure / thromboembolic event) for AF as judged by the investigator. Exclusion Criteria: Colchicine treatment for another cause, e.g. gout Allergy/hypersensitivity to colchicine Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg) 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 Cirrhosis, chronic active hepatitis or other severe hepatic disease Hemodialysis Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1) Permanent AF Female participants who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion Significant drug or alcohol abuse during the last year Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed) Planned ablation procedure as treatment for AF If cardiovascular surgery or ablation has been done the past three months prior to inclusion. Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea Use of other investigational drugs within 30 days of the time of enrollment 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. Suspected AF, confirmed with ECG, at time of inclusion and randomization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Femerling Langhoff, M.D.
Phone
+4522552317
Email
adam.femerling.langhoff@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tor Biering-Sørensen, MD, PhD, MPH
Phone
+4528933590
Email
tor.biering-soerensen@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Femerling Langhoff, M.D.
Organizational Affiliation
Herlev and Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Femerling Langhoff, MD
Phone
+4522552317
Email
adam.femerling.langhoff@regionh.dk
First Name & Middle Initial & Last Name & Degree
Tor Biering-Sørensen, MD, PhD, MPH
Phone
+4528933590
Email
tor.biering-soerensen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The COLchicine and Atrial FIBrillation Trial

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