Study on Colchicine for Reducing Atrial Fibrillation Recurrence in Patients Undergoing Electrical Cardioversion

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What is this study about?

This clinical trial is focused on studying the effects of a medication called colchicine on a heart condition known as atrial fibrillation or atrial flutter. These conditions involve irregular heartbeats that can lead to various complications. The study aims to determine if colchicine can help reduce the recurrence of these irregular heartbeats in patients who are scheduled for a procedure called electrical cardioversion, which is used to restore a normal heart rhythm.

Participants in the study will receive either colchicine or a placebo, which looks the same as the medication but does not contain the active ingredient. The study will monitor the time it takes for the first recurrence of atrial fibrillation after starting the medication. Over the course of the study, which may last up to a year, researchers will also observe the number of times participants are readmitted to the hospital for symptoms, changes in heart function as seen on an ultrasound, and any changes in quality of life or potential side effects.

The purpose of this study is to explore whether colchicine could be repurposed as a treatment for atrial fibrillation, potentially offering a new option for managing this condition. The results of this trial are expected to provide valuable insights into the effectiveness of colchicine in preventing the recurrence of atrial fibrillation in patients undergoing cardioversion.

1 joining the study

Upon joining the study, you will be required to provide written, informed consent. This confirms your understanding and willingness to comply with the study requirements.

You must meet the inclusion criteria, which include being over 18 years old, having a diagnosis of paroxysmal or persistent atrial fibrillation (AF), and being scheduled for electrical cardioversion with a successful outcome.

2 medication administration

You will be administered colchicine orally. The specific dosage and frequency will be determined by the study protocol and communicated to you by the study team.

The duration of the medication administration will be aligned with the study’s objectives to assess its effects on AF recurrence.

3 monitoring and follow-up

Throughout the study, your health and response to the medication will be closely monitored. This includes regular check-ups and assessments.

You will be evaluated for any changes in your condition, including the time to first AF admission and any potential side effects.

4 end of study assessments

At the end of the study, which is estimated to conclude by May 2028, you will undergo final assessments.

These assessments will include measuring the accumulated number of readmissions for symptomatic AF, changes in echocardiographic measurements, quality of life scores, and any side effects experienced over the 12-month period.

Who Can Join the Study?

Must be over 18 years old.
Must have been diagnosed with paroxystic/persistent AF (a type of irregular heartbeat).
Must be scheduled for or have had a successful cardioversion (a procedure to restore a normal heart rhythm) for AF.
Female participants must either be unable to have children (postmenopausal for at least 1 year or surgically sterile) or, if they can have children, must use one of the following birth control methods during the study and for 30 days after: hormonal contraception (like birth control pills, implant, injection, patch, or ring) or an intrauterine device (IUD).
Must have given written, informed consent and be willing to follow the study requirements.
Must be on the best possible treatment for AF, considering other health conditions and the risk of heart failure or blood clots, as determined by the study doctor.

Who Cannot Join the Study?

Patients with a history of atrial fibrillation or atrial flutter cannot participate. These are conditions where the heart beats irregularly or too fast.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Gentofte Hospital	Hellerup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2022

Trial locations

Investigated drugs:

Autumn Crocus Fresh Flower Fluid Extract (1:15-25), Extraction Solvent Ethanol 96% (V/V)

Colchicine is a medication that is being studied for its potential benefits in treating atrial fibrillation, a condition where the heart beats irregularly. In this trial, researchers are looking to see if colchicine can help reduce the recurrence of atrial fibrillation in patients who are undergoing a procedure called electrical cardioversion. This procedure is used to restore a normal heart rhythm. The goal is to find out if colchicine can be used as a treatment for people who experience episodes of atrial fibrillation.

Investigated diseases:

Atrial fibrillation

Atrial Fibrillation – Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) experience chaotic electrical signals, causing them to quiver instead of contracting effectively. This can lead to poor blood flow and may cause symptoms such as palpitations, fatigue, and shortness of breath. The condition can be intermittent or persistent, with episodes that may last from minutes to hours or even longer. Over time, atrial fibrillation can lead to changes in the heart’s structure and function. It is often associated with other heart-related conditions and can progress with age.

Atrial Flutter – Atrial flutter is a type of abnormal heart rhythm, or arrhythmia, where the atria of the heart beat very fast but in a regular pattern. This rapid beating can cause the heart to pump less efficiently, leading to symptoms like palpitations, dizziness, and shortness of breath. Unlike atrial fibrillation, the electrical activity in atrial flutter is more organized, but it can still result in similar complications. The condition can occur in episodes or be sustained over time. Atrial flutter often occurs in people with other heart conditions and can sometimes progress to atrial fibrillation. It is important to monitor as it can affect the heart’s ability to function properly.

Trial ID:

2022-500850-40-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Colchicine for Reducing Atrial Fibrillation Recurrence in Patients Undergoing Electrical Cardioversion

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?