Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Nov 2019
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedFirst Posted
Study publicly available on registry
November 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedNovember 7, 2019
November 1, 2019
3 years
September 11, 2019
November 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 months
Secondary Outcomes (1)
Alpha Defensin levels in patients with recurrence of atrial fibrillation
12 months
Study Arms (2)
Control Group
NO INTERVENTIONCardioversion without treatment with Colchicine
Treatment group
ACTIVE COMPARATORThis arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months
Interventions
Administration of Colchicine at a dose of 0.5mg 2x a day for six months.
Eligibility Criteria
You may qualify if:
- Atrial fibrillation
- Candidate for cardioversion
You may not qualify if:
- Colchicine allergy
- Hepatic or renal failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Investigator and participants will be blinded regarding levels of anti-inflammatory markers
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2019
First Posted
November 7, 2019
Study Start
November 1, 2019
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
November 7, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share