RecruitingNAINTERVENTIONAL

Responding to AF: Pill-in-Pocket Anticoagulation Guided by Automated Monitoring and Alerts

This study, called RESPOND-AF, explores a new way to manage Atrial Fibrillation (AF), a common irregular heartbeat. Many people with AF take blood thinners every day to prevent strokes. This new approach, called "pill-in-pocket" anticoagulation, suggests taking blood thinners only when an AF episode occurs, and for a short time afterwards. This could be good for people with less frequent AF or those who want to reduce their exposure to blood thinners. The study uses a tiny implanted heart monitor that sends an alert to your phone if it detects AF, telling you to take your medication. This aims to empower patients and potentially reduce side effects from continuous medication.

At a glance

Status

Recruiting

Phase

Sponsor

Oxford University Hospitals NHS Trust

Enrolment target

Start

14 Apr 2025

Estimated completion

15 Apr 2027

Atrial Fibrillation (AF)Atrial Fibrillation (Prevention of Stroke)

What is this study about?

Atrial Fibrillation (AF) is a very common condition where the heart beats in an irregular way, affecting millions of people in the UK. This irregular heartbeat can be short-lived, appearing now and then, or it can last for longer periods. The main concern with AF is the increased risk of stroke. This happens because the irregular heartbeat can cause blood to pool and form clots in the heart, which can then travel to the brain and cause a stroke.

Currently, most people with AF who are at risk of stroke take blood-thinning medication every day. This helps prevent clots from forming. However, taking blood thinners all the time can have side effects, such as a higher risk of bleeding. This study explores a different idea called "pill-in-pocket" anticoagulation. The thought is that the risk of stroke from AF isn't constant; it tends to be higher just after an AF episode and for a few weeks afterwards. So, instead of taking medication daily, what if you only took it when you had an AF episode, and for a short time after your heart returned to its normal rhythm?

This study, RESPOND-AF, is testing a new way to make this "pill-in-pocket" approach work. Participants would have a small heart monitor implanted that constantly checks their heart rhythm. If it detects AF, a special computer program would instantly send a message to a smartphone, telling the patient to take their blood-thinning medicine. The aim is to act quickly, as starting blood thinners within 48 hours of an AF episode is important to help prevent clots. If this study shows that this method is safe, works well, and is easy for patients to use, it could offer a new, more tailored treatment option for some people with AF.

Key takeaways

Exploring a new way to manage Atrial Fibrillation (AF).
Focuses on taking blood thinners only when AF episodes occur.
Uses a small implanted monitor and smartphone alerts.
Could reduce daily medication and potential side effects.
Aims to empower patients with more treatment choices.
A pilot study for safety and effectiveness.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a type of AF that is not constant (meaning it comes and goes, or your heart is usually in a normal rhythm). Your doctor would also need to confirm that you are generally healthy enough to reduce your current daily blood thinner medication, or willing to start one if you're not currently on it.

There are some reasons why you couldn't join. For example, if you've already had a stroke or a mini-stroke (TIA), or if you have certain other heart conditions like a mechanical heart valve. Also, if you have very severe kidney disease, are pregnant or planning to be, or have trouble seeing or using a smartphone, this study might not be right for you. The study also requires you to be able to use a specific smartphone app and be able to take the study medication when instructed.

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?
Do you have a type of AF that isn't constant (e.g., it comes and goes)?
Are you willing to change your blood thinner routine or start taking one if needed?
Do you not have a history of stroke or certain other serious heart conditions?
Can you use a smartphone and its apps, and are you able to read phone notifications?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first give your informed consent, meaning you understand what's involved and agree to take part. A tiny heart monitor would be placed under your skin to keep track of your heart rhythm continuously. You would need to have a smartphone that can receive alerts and use the study's app. When the monitor detects an AF episode, you would receive an alert on your phone telling you to start taking your blood-thinning medication. You would then continue taking it for a set period after your heart returns to normal rhythm. The study will involve regular check-ups to ensure your safety and monitor your progress. The total duration of your participation in the study would be discussed with the study team.

Potential risks and benefits

Potential benefits of taking part include contributing to research that might offer a new, more flexible way to manage AF, potentially reducing the overall amount of blood-thinning medication you need to take and the associated bleeding risks. You would also have continuous heart monitoring. Potential risks include those associated with implanting the heart monitor, and the possibility that this new medication approach might not be as effective as standard daily treatment in preventing strokes for everyone, or could still carry bleeding risks. You have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

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

Oxford University Hospitals NHS Trust, John Radcliffe Hospital
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is Atrial Fibrillation (AF)?

AF is a common heart condition where your heart beats irregularly or flutters.

What is 'pill-in-pocket' anticoagulation?

It's a new idea where you take blood-thinning medicine only when your AF acts up, instead of every day.

How will I know when to take the medicine?

A small heart monitor will be implanted. If it detects AF, it will send an alert to your smartphone.

Why is this study important?

It could offer a new treatment choice for people with AF, potentially reducing the need for daily medication and its side effects.

Will I still be at risk of stroke?

The study aims to see if this new method can safely prevent strokes, but all treatments carry some level of risk. Your doctors will discuss this with you.

How to find out more

Dr Richard K. Varini MBChB MRCPI

richard.varini@ouh.nhs.uk +441865220255 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.