- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155879
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 Contact
- Name: Asaf Danon, MD, MSC
- Phone Number: 972-55-8867102
- Email: asdanon@gmail.com
Study Locations
-
-
-
Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
Contact:
- Asaf Danon, MD, MSC
- Phone Number: 972-55-8867102
- Email: asdanon@gmail.com
-
-
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
|
Administration of Colchicine at a dose of 0.5mg 2x a day for six months.
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
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
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Disease Attributes
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Recurrence
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gout Suppressants
- Colchicine
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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