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

November 6, 2019 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Atrial fibrillation
  • Candidate for cardioversion

Exclusion Criteria:

  • Colchicine allergy
  • Hepatic or renal failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of atrial fibrillation
Time Frame: 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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alpha Defensin levels in patients with recurrence of atrial fibrillation
Time Frame: 12 months
Alpha Defensin levels will be measured in patients with recurrence of atrial fibrillation and compared to levels in patients without recurrence.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

November 1, 2022

Study Registration Dates

First Submitted

September 11, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

November 7, 2019

Last Update Submitted That Met QC Criteria

November 6, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-19-0074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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