Not recruiting

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

Verified siteRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

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.

The research process

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

Step 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.
Step 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.
Step 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.
Step 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 trial?

3 criteria

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 trial?

4 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
General Hospital Of Nea Ionia Konstantopouleio Patision
Nea Ionia, Greece
Verified
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Chaidari, Greece
Verified
University General Hospital Of Alexandroupoli
Alexandroupoli, Greece

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Flecainide
Flecainide is administered intravenously and is used to restore normal heart rhythm in patients with recent onset atrial fibrillation. It is well-documented in medical literature as an antiarrhythmic medication. The main therapeutic indication is the restoration of sinus rhythm in patients with atrial fibrillation. At the molecular level, flecainide works by blocking sodium channels in the heart, which helps to stabilize the cardiac electrical activity. It is classified pharmacologically as a Class IC antiarrhythmic agent.
Ranolazine
Ranolazine is taken orally and is used in combination with other medications to help restore normal heart rhythm in patients with recent onset atrial fibrillation. It is recognized in medical literature for its role in managing heart conditions. The primary therapeutic indication is to assist in the restoration of sinus rhythm when used with other antiarrhythmic drugs. Ranolazine works by inhibiting the late phase of the sodium current in the heart, which helps to reduce abnormal electrical activity. It is classified as an antianginal medication.

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.