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Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

Atrial Fibrillation Recurrence Following Cardioversion: the Role of Clinical Factors and Alpha Defensin Levels

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04155879
Enrollment
300
Registered
2019-11-07
Start date
2019-11-30
Completion date
2022-11-30
Last updated
2019-11-07

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

Conditions

Atrial Fibrillation

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.

Interventions

Administration of Colchicine at a dose of 0.5mg 2x a day for six months.

PROCEDURECardioversion

Electrical or pharmacologic restoration of sinus rhythm

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Investigator and participants will be blinded regarding levels of anti-inflammatory markers

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Atrial fibrillation * Candidate for cardioversion

Exclusion criteria

* Colchicine allergy * Hepatic or renal failure

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of atrial fibrillation12 monthsAtrial 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

MeasureTime frameDescription
Alpha Defensin levels in patients with recurrence of atrial fibrillation12 monthsAlpha Defensin levels will be measured in patients with recurrence of atrial fibrillation and compared to levels in patients without recurrence.

Countries

Israel

Contacts

Primary ContactAsaf Danon, MD, MSC
asdanon@gmail.com972-55-8867102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026