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

NCT ID: NCT04155879

Last Updated: 2019-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

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

Study Groups

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Control Group

Cardioversion without treatment with Colchicine

Group Type NO_INTERVENTION

No interventions assigned to this group

Treatment group

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

Group Type ACTIVE_COMPARATOR

Colchicine Tablets

Intervention Type DRUG

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

Cardioversion

Intervention Type PROCEDURE

Electrical or pharmacologic restoration of sinus rhythm

Interventions

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Colchicine Tablets

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

Intervention Type DRUG

Cardioversion

Electrical or pharmacologic restoration of sinus rhythm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Atrial fibrillation
* Candidate for cardioversion

Exclusion Criteria

* Colchicine allergy
* Hepatic or renal failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Asaf Danon, MD, MSC

Role: CONTACT

972-55-8867102

Facility Contacts

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Asaf Danon, MD, MSC

Role: primary

972-55-8867102

Other Identifiers

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HYMC-19-0074

Identifier Type: -

Identifier Source: org_study_id

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