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Study Comparing Two Amiodarone Doses to Maintain Heart Rhythm in Patients with Persistent Atrial Fibrillation After Cardioversion

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying persistent atrial fibrillation, a condition where the heart beats irregularly and often rapidly for extended periods. The study aims to evaluate the effectiveness of two different doses of a medication called amiodarone hydrochloride, which is used to help maintain a normal heart rhythm after a procedure known as cardioversion. Cardioversion is a treatment that helps restore a regular heart rhythm in people with certain types of abnormal heartbeats.

The purpose of the study is to compare the ability of a standard dose (200 mg per day) and a reduced dose (100 mg per day) of amiodarone hydrochloride to maintain a normal heart rhythm for 12 months after cardioversion in patients with persistent atrial fibrillation. Participants in the study will be randomly assigned to receive either the standard dose or the reduced dose of the medication. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient.

Throughout the study, participants will be monitored for any recurrence of irregular heartbeats and for any side effects that may occur. The study will also look at how the body processes the medication and whether genetic factors affect its effectiveness and safety. The trial is expected to continue until June 2028, with recruitment starting in November 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing an informed consent form, confirming understanding and agreement to the study terms.

    Eligibility is confirmed based on criteria such as being 18 years or older, having persistent atrial fibrillation lasting at least 7 days, and being scheduled for electrical cardioversion while on amiodarone treatment.

  2. Step 2

    Randomization and initial treatment

    Participants are randomly assigned to one of two groups to receive either a standard dose of amiodarone hydrochloride 200 mg per day or a reduced dose of 100 mg per day.

    The medication is administered orally in tablet form.

  3. Step 3

    Electrical cardioversion

    Undergo electrical cardioversion, a procedure to restore normal heart rhythm in cases of persistent atrial fibrillation.

  4. Step 4

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor heart rhythm and assess the effectiveness of the treatment in maintaining sinus rhythm over a 12-month period.

    Monitoring includes checking for any recurrence of atrial fibrillation using an electrocardiogram (ECG).

  5. Step 5

    Assessment of side effects

    Potential side effects are evaluated, including thyroid function tests (TSH levels), liver function tests (AST, ALT, GGT), and heart rhythm assessments (QTc interval).

    Additional assessments may include genetic studies to understand how different genetic profiles affect drug metabolism and response.

  6. Step 6

    Completion of the study

    The study concludes after 12 months of follow-up, with a final assessment of heart rhythm and any side effects experienced during the trial period.

Who can join the trial?

4 criteria

  • Patients must be **18 years or older**.
  • Must have **persistent atrial fibrillation**, which means the heart has been beating irregularly for **7 days or more**.
  • Must be **scheduled for a procedure called Electrical Cardioversion** while being treated with a medication called **amiodarone**. Electrical Cardioversion is a treatment that uses electricity to help the heart beat normally.
  • Must have **signed an informed consent**, which means they agree to participate in the study after understanding what it involves.

Who cannot join the trial?

3 criteria

  • Patients who do not have persistent atrial fibrillation cannot participate. This is a condition where the heart has an irregular and often rapid heartbeat that lasts for a long time.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

Amiodarone is a medication used to help maintain a normal heart rhythm in patients who have experienced atrial fibrillation, a condition where the heart beats irregularly. In this clinical trial, the role of amiodarone is to help keep the heart beating in a regular rhythm after a procedure called electrical cardioversion, which is used to restore a normal heart rhythm. The trial is comparing the effectiveness of two different regimens of amiodarone to see which one is better at maintaining a normal heart rhythm over a period of 12 months.

What is already known about the treatment

Amiodarone – Amiodarone is administered orally in tablet form and is used to help maintain a normal heart rhythm in patients with persistent atrial fibrillation. It is well-documented in medical literature and is currently being evaluated in clinical trials to determine the effectiveness of different dosing regimens. The main therapeutic indication for amiodarone is to maintain sinus rhythm after cardioversion in atrial fibrillation. At the molecular level, amiodarone works by blocking certain electrical signals in the heart that can cause an irregular heartbeat. It is classified as an antiarrhythmic medication.

Investigated diseases

Persistent atrial fibrillation – This is a type of irregular heartbeat that lasts longer than seven days and may require medical intervention to restore a normal rhythm. It occurs when the upper chambers of the heart (atria) beat irregularly and out of sync with the lower chambers (ventricles). This condition can lead to symptoms such as palpitations, shortness of breath, and fatigue. Over time, persistent atrial fibrillation can affect the heart's ability to pump blood efficiently. It may also increase the risk of developing blood clots, which can lead to complications. The condition often requires ongoing management to maintain a regular heart rhythm.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514113-35-01Protocol codeIIBSP-AMI-2024-33Estimated enrolment312 patientsSponsorFundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

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