Study on Flecainide and Ranolazine for Restoring Heart Rhythm in Patients with Recent Atrial Fibrillation

3 1 1 1

What is this study about?

This clinical trial is focused on studying a condition known as Atrial Fibrillation (AF), which is a common heart rhythm disorder where the heart beats irregularly and often rapidly. The study aims to compare two treatment methods to restore a normal heart rhythm, known as sinus rhythm, in patients who have recently developed AF. The treatments being compared are intravenous flecainide alone and a combination of intravenous flecainide with oral ranolazine. Flecainide and ranolazine are medications used to help control heart rhythm.

The purpose of the study is to determine which treatment is more effective in restoring normal heart rhythm in patients who have experienced AF for less than 48 hours. Participants in the study will receive either the combination of flecainide and ranolazine or flecainide alone. The study will monitor how quickly and effectively each treatment restores normal heart rhythm.

Participants will be observed to see how many of them return to a normal heart rhythm within three hours and six hours after starting the treatment. The study will help to understand if adding ranolazine to flecainide provides any additional benefit in treating recent onset AF compared to using flecainide alone. This information could be valuable in improving treatment strategies for patients with this heart condition.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must be at least 18 years old and have atrial fibrillation (AF) that started within the last 48 hours.

2 treatment initiation

The treatment begins with the administration of intravenous flecainide. This is a medication given through a vein to help restore normal heart rhythm.

Participants are randomly assigned to receive either intravenous flecainide alone or in combination with oral ranolazine. Ranolazine is a medication taken by mouth.

3 monitoring period

Participants are monitored for the restoration of normal heart rhythm, known as sinus rhythm, within 3 hours of starting the treatment.

The effectiveness of the treatment is assessed by comparing the percentage of participants who achieve sinus rhythm within 3 hours and 6 hours.

4 completion of treatment

The study aims to determine the time it takes for the heart rhythm to return to normal with the different treatment options.

The study is expected to conclude by June 30, 2025.

Who Can Join the Study?

  • Patients must be 18 years or older.
  • Patients must have AF (atrial fibrillation), which is a type of irregular heartbeat, confirmed by an electrocardiogram (a test that records the electrical activity of the heart).
  • The AF must have started recently, with the patient reporting the start of the irregular heartbeat within 48 hours before beginning treatment to restore normal heart rhythm.

Who Cannot Join the Study?

  • Patients who have had atrial fibrillation (AF) for more than 48 hours. AF is a condition where the heart beats in an irregular and often rapid way.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means they might need special protection or care.
  • Patients who are not eligible based on other specific criteria set by the study, which are not detailed here.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
General Hospital Venizeleio-Pananeio Heraklion Greece

Other Sites

Site Name City Country Status
General Hospital Of Nea Ionia Konstantopouleio Patision Nea Ionia Greece
Asklepieion Voulas General Hospital Voula Greece
Evangelismos S.A. Athens Greece
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
General University Hospital Of Patras Patras Greece
University General Hospital Of Alexandroupoli Alexandroupoli Greece
Mitera S.A. Athens Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Gwhnduq Hahvpwvt ou Kwnfsepv Karditsa Greece
Gnzxiyn Hmblhvbd Os Ibpamhm Mbqjrv Vnlpt Veria Greece

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

Trial status

Country Status Recruitment Start
Greece Greece
Not recruiting
31.01.2022

Trial locations

Flecainide is a medication used to treat irregular heartbeats, specifically atrial fibrillation. In this study, it is given through an intravenous (IV) line, which means it is administered directly into the bloodstream. The goal of using flecainide is to help restore a normal heart rhythm in patients who have recently developed atrial fibrillation.

Ranolazine is a medication that is taken by mouth (orally) and is used to help improve blood flow to the heart. In this study, ranolazine is used in combination with flecainide to see if it can enhance the effectiveness of flecainide in restoring a normal heart rhythm in patients with recent onset atrial fibrillation.

Investigated diseases:

Atrial Fibrillation – Atrial fibrillation (AF) 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 like palpitations, shortness of breath, and fatigue. AF can occur in episodes that come and go or may be persistent, requiring medical intervention to restore normal rhythm. The condition can develop suddenly, often within 48 hours, and may be triggered by stress, illness, or other heart-related issues. Over time, AF can lead to complications such as blood clots or heart failure if not managed properly. The focus in treatment is often on restoring and maintaining a normal heart rhythm.

Trial ID:
2024-514677-22-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A Study to Test How Well PKN605 Works and How Safe It Is in Patients with Atrial Fibrillation

    Recruiting

    2 1
    Germany The Netherlands
  • Study of AP31969 compared to placebo to control heart rhythm in patients with atrial fibrillation

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark Germany Hungary Italy The Netherlands +1