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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04155879
Other study ID # HYMC-19-0074
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2019
Est. completion date November 2022

Study information

Verified date November 2019
Source Hillel Yaffe Medical Center
Contact Asaf Danon, MD, MSC
Phone 972-55-8867102
Email asdanon@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Atrial fibrillation

- Candidate for cardioversion

Exclusion Criteria:

- Colchicine allergy

- Hepatic or renal failure

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Colchicine Tablets
Administration of Colchicine at a dose of 0.5mg 2x a day for six months.
Procedure:
Cardioversion
Electrical or pharmacologic restoration of sinus rhythm

Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 12 months
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