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

Sponsor

Hillel Yaffe Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04155879

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Colchicine Tablets Procedure: Cardioversion	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group Cardioversion without treatment with Colchicine
Active Comparator: Treatment group This arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months	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

Arm

Intervention/Treatment

No Intervention: Control Group

Cardioversion without treatment with Colchicine

Active Comparator: Treatment group

This arm will undergo cardioversion followed by Colchicine (0.5 mg 2x per day) for six months

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

Outcome Measures

Primary Outcome Measures

Recurrence of atrial fibrillation [12 months]
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 [12 months]
Alpha Defensin levels will be measured in patients with recurrence of atrial fibrillation and compared to levels in patients without recurrence.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Atrial fibrillation
Candidate for cardioversion

Exclusion Criteria:

Colchicine allergy
Hepatic or renal failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillel Yaffe Medical Center	Hadera		Israel	38100

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT04155879

Other Study ID Numbers:

HYMC-19-0074

First Posted:

Nov 7, 2019

Last Update Posted:

Nov 7, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Recurrence

Colchicine

Study Results

No Results Posted as of Nov 7, 2019