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

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What is this study about?

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.

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 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 electrical cardioversion

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

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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Universidade De Santiago De Compostela Santiago De Compostela Spain
Salut Sant Joan De Reus Reus Spain
Hkanfavu Du Lg Skgzt Cqai I Slks Php Barcelona Spain
Hglznibo Uxvbbdewxmxlk Hirqrqmk Tauoq y Pkdxyl Ipghzjzb Cjdufe dqetgunqslhrgsuhl (hcet Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.11.2024

Trial locations

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.

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 ID:
2024-514113-35-01
Protocol code:
IIBSP-AMI-2024-33
Trial Phase:
Therapeutic confirmatory (Phase III)

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