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Study on Amiodarone for Patients with Persistent Atrial Fibrillation Undergoing Electrical 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 the effects of the medication amiodarone in patients with atrial fibrillation, a condition where the heart beats irregularly and often rapidly. The trial aims to evaluate how well amiodarone can help restore a normal heart rhythm before a procedure called electrical cardioversion, which is used to correct the heart's rhythm. The medication being tested is called Trangorex 200 mg tablets, which contain the active ingredient amiodarone hydrochloride.

The purpose of the study is to compare two different treatment plans using amiodarone. One group of patients will take the medication for one month, while another group will take it for five days before undergoing electrical cardioversion. The study will observe how effective amiodarone is in helping the heart return to a normal rhythm and how long this normal rhythm is maintained after the procedure.

Participants in the study will be monitored to see how quickly their heart rhythm returns to normal after starting amiodarone and whether the normal rhythm is maintained during the month following the electrical cardioversion. The study will provide valuable information on the best way to use amiodarone for patients with persistent atrial fibrillation, which is when the irregular heart rhythm lasts for seven days or more.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria: being 18 years or older, having persistent atrial fibrillation lasting 7 days or more, and being referred for elective electrical cardioversion. Signing an informed consent form is required.

  2. Step 2

    Medication regimen

    The study involves taking amiodarone hydrochloride, a medication used to help restore normal heart rhythm. The medication is administered orally in the form of Trangorex 200 mg tablets.

    Participants are divided into two groups. One group follows a one-month regimen, while the other follows a 5-day regimen before undergoing electrical cardioversion.

  3. Step 3

    Monitoring and evaluation

    The primary goal is to assess the effectiveness of amiodarone in restoring normal heart rhythm before electrical cardioversion.

    Secondary evaluations include measuring the time taken for the heart rhythm to return to normal after starting amiodarone and maintaining this rhythm for a month following the procedure.

  4. Step 4

    Completion of the study

    The study is expected to conclude by March 31, 2026. Participants will be monitored throughout the study to ensure safety and effectiveness of the treatment.

Who can join the trial?

4 criteria

  • Patients must be **18 years old** or older.
  • Patients must have **persistent atrial fibrillation**, which means their heart has been beating irregularly for **7 days or more**.
  • Patients must be referred for a planned procedure called **elective electrical cardioversion**, which is a treatment to help the heart return to a normal rhythm.
  • Patients must sign an **informed consent**, which is a document that explains the study and confirms their agreement to participate.

Who cannot join the trial?

4 criteria

  • Patients with certain heart conditions other than atrial fibrillation may not be eligible. Atrial fibrillation is a condition where the heart beats in an irregular and often rapid way.
  • Individuals who are not within the specified age range for the study may be excluded. The study is open to certain age groups only.
  • Participants who are part of a vulnerable population, meaning those who might be at higher risk of harm or exploitation, are not eligible.
  • Both males and females can participate, but there may be specific criteria related to gender that could exclude someone.
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Investigated drugs

Amiodarone is a medication used in this clinical trial to help restore a normal heart rhythm in patients with persistent atrial fibrillation. The trial is investigating how effective amiodarone is when given before an electrical procedure called cardioversion, which is used to correct irregular heartbeats. The study compares two different time frames for taking amiodarone: one group takes it for one month, and the other group takes it for five days before the procedure. The goal is to see which regimen is more effective in helping the heart return to a normal rhythm.

What is already known about the treatment

Amiodarone – Amiodarone is administered orally or intravenously, depending on the specific medical situation. It is currently well-established in medical practice and literature as a treatment for various heart rhythm disorders. The main therapeutic indication for amiodarone is the management of atrial fibrillation, particularly in restoring normal heart rhythm before electrical cardioversion. At the molecular level, amiodarone works by blocking certain electrical signals in the heart that can cause irregular heartbeats. It is classified pharmacologically as an antiarrhythmic medication.

Investigated diseases

Atrial fibrillation – Atrial fibrillation is a common heart rhythm disorder where the heart's upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and may cause symptoms such as palpitations, shortness of breath, and fatigue. The condition can be persistent, lasting for more than a week, or it can come and go. Over time, atrial fibrillation can lead to complications if not managed properly. The heart's ability to pump blood efficiently may be compromised, affecting overall circulation. It is important to monitor and manage the condition to maintain a regular heart rhythm.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507201-34-00Protocol codePERIVERSIONEstimated enrolment130 patientsSponsorInstitut D Investigacio Sanitaria Pere Virgili

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