Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Comparison of the effectiveness of IntraVenous FLECainide plus oral ranolazine versus intravenous flecainide alone in the cardioversion of recent onset atrial fibrillation - a randomized, prospective, multicentre, open-label study, the IV-FLEC study.

This research study, called the IV-FLEC study, is investigating the best way to treat a common heart condition known as atrial fibrillation (AF). When someone has AF, their heart beats irregularly and often quickly. The study focuses on people who have recently developed AF, specifically within the last 48 hours. Researchers are comparing two treatment approaches: one group will receive a medicine called flecainide through a drip (into a vein) along with a tablet called ranolazine. The other group will receive flecainide through a drip on its own. The main aim is to find out if the combination treatment is more effective at returning the heart to a regular beat (sinus rhythm) within a short time, typically three hours, compared to flecainide treatment alone. This is important to help doctors understand the best and quickest way to help patients with recent AF.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Win Medica Pharmaceutical A.E.

Enrolment target

210

Start

09 Sep 2024

Restoration of sinus rhythm in patients with recent AF onset

What is this study about?

This study is looking at a common heart condition called atrial fibrillation, often shortened to AF. When you have AF, the upper chambers of your heart beat irregularly and sometimes very quickly. This can make you feel tired, dizzy, or notice your heart pounding. Doctors often try to get your heart back to a normal, steady rhythm, which they call 'sinus rhythm', as quickly as possible.

In this study, researchers are comparing two ways to help people whose AF has just started (within the last 48 hours). One treatment involves a medicine called flecainide, which is given directly into a vein through a drip, combined with a tablet called ranolazine. The other treatment is flecainide given through a drip on its own. The main idea is to see which of these ways is more successful at quickly returning the heart to a normal beat.

This kind of study is called a 'Phase III' study. This means these medicines have already been tested and shown to be safe and helpful in earlier stages of research. Now, doctors want to confirm how well they work and compare them directly to see which approach is better for patients. Finding the most effective and quickest treatment can help people with recent AF feel better sooner and reduce potential complications.

Key takeaways

The study compares two treatments for recently started atrial fibrillation (AF).
It aims to see if combining flecainide and ranolazine works better or faster than flecainide alone.
Participation involves receiving one of the two treatments and having your heart rhythm closely monitored.
The goal is to help doctors improve treatment for AF patients.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be considered for this study, you would generally need to be an adult, aged 18 years or older, with no upper age limit. The study is open to both men and women.

The most important health condition for this study is that you have been recently diagnosed with atrial fibrillation (AF). This means your irregular heartbeat must have started within the last 48 hours for you to be eligible. The hospital team would check this carefully to make sure you fit the criteria for the study.

There might be other specific health checks or conditions that would mean you couldn't take part, even if you meet the main criteria. For example, if you have certain other heart conditions or are taking particular medications, the study doctors would review your full health history to ensure the study is safe and appropriate for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has your irregular heartbeat (atrial fibrillation) been diagnosed very recently, within the last 48 hours?
Are you comfortable with the idea of receiving study medication?
Are you able to attend follow-up appointments if required?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be randomly assigned to receive one of two treatments: either flecainide given into a vein plus ranolazine tablets, or flecainide given into a vein on its own. 'Randomly assigned' means it's like flipping a coin – neither you nor your doctor chooses which treatment you get.

Doctors and nurses would closely monitor your heart rhythm to see how quickly it returns to normal. They would measure your heart's electrical activity using an ECG (a heart tracing) at regular intervals. They would also monitor you for any side effects from the medication. The initial treatment and monitoring period would take a few hours, likely within a hospital setting. The total duration of your active involvement in the study would depend on how quickly your heart rhythm normalises and any follow-up assessments required, which would be explained in full detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment that could be more effective or quicker at returning your heart to a normal rhythm compared to standard care. However, there's no guarantee of personal benefit. Potential risks include side effects from the medications, which your doctor and nurses will explain fully and monitor closely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Greece

Common questions

What is atrial fibrillation (AF)?

AF is a heart condition where the upper chambers of your heart beat irregularly and sometimes very quickly, causing symptoms like palpitations or dizziness.

What does 'restoration of sinus rhythm' mean?

This means your heart is successfully brought back to its normal, regular beating pattern, which is known as sinus rhythm.

What is flecainide and ranolazine?

Flecainide is a medicine given into a vein to help correct irregular heartbeats. Ranolazine is a tablet that can also help with heart conditions. The study is checking if they work better together for AF.

How long will I be in the study if I take part?

The main part of monitoring for this study, focusing on your heart rhythm, would likely be for a few hours. The full duration of your participation would be explained by the study team.

Why is this study important?

This study aims to find the best and quickest treatment approach for people who have recently developed atrial fibrillation, which could help many patients feel better sooner.