Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Colchicine Tablets
Cardioversion
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- Atrial fibrillation
- Candidate for cardioversion
Exclusion Criteria:
- Colchicine allergy
- Hepatic or renal failure
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control Group
Treatment group
Arm Description
Cardioversion without treatment with Colchicine
This arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months
Outcomes
Primary Outcome Measures
Recurrence of atrial fibrillation
Atrial fibrillation recurrence rates over the next 12 months will be determined based on medical records and ECG documentation between treatment group (Colchicine) and control group.
Secondary Outcome Measures
Alpha Defensin levels in patients with recurrence of atrial fibrillation
Alpha Defensin levels will be measured in patients with recurrence of atrial fibrillation and compared to levels in patients without recurrence.
Full Information
NCT ID
NCT04155879
First Posted
September 11, 2019
Last Updated
November 6, 2019
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04155879
Brief Title
Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels
Official Title
Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Atrial fibrillation and inflammation are strongly correlated. The aim of this study is to evaluate whether inflammation markers (alpha Defensin) predict maintenance of sinus rhythm following cardioversion. A secondary aim is to evaluate the role of Colchicine, an anti-inflammatory medication, in reducing the recurrence rate of atrial fibrillation.
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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Investigator and participants will be blinded regarding levels of anti-inflammatory markers
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Cardioversion without treatment with Colchicine
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
This arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months
Intervention Type
Drug
Intervention Name(s)
Colchicine Tablets
Intervention Description
Administration of Colchicine at a dose of 0.5mg 2x a day for six months.
Intervention Type
Procedure
Intervention Name(s)
Cardioversion
Intervention Description
Electrical or pharmacologic restoration of sinus rhythm
Primary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Description
Atrial fibrillation recurrence rates over the next 12 months will be determined based on medical records and ECG documentation between treatment group (Colchicine) and control group.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Alpha Defensin levels in patients with recurrence of atrial fibrillation
Description
Alpha Defensin levels will be measured in patients with recurrence of atrial fibrillation and compared to levels in patients without recurrence.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Atrial fibrillation
Candidate for cardioversion
Exclusion Criteria:
Colchicine allergy
Hepatic or renal failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asaf Danon, MD, MSC
Phone
972-55-8867102
Email
asdanon@gmail.com
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asaf Danon, MD, MSC
Phone
972-55-8867102
Email
asdanon@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels
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