RecruitingPhase IIIInterventional

Investigating the clinical and cost-effectiveness of two different drugs (amiodarone and beta blockers) to treat patients with new-onset atrial fibrillation whilst in the intensive care unit

When people are very unwell in an intensive care unit (ICU), the physical stress on their body can cause an irregular heartbeat called new-onset atrial fibrillation. This can slow down recovery and raise the risk of further health problems like stroke. Doctors currently treat this using two common types of medicines: amiodarone or beta-blockers. Both are widely used across the NHS, but we do not yet know which one is more effective or has fewer side effects for patients in intensive care. In this study, adult patients who develop this irregular heartbeat will be randomly assigned to receive one of the two medicines through a drip or as tablets. The medical team will track their recovery while in hospital and follow up with two phone calls at two and three months to see how they are doing.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University of Birmingham

Enrolment target

2,560

Start

08 May 2024

Estimated completion

30 Apr 2029

New onset atrial fibrillation (NOAF)

What is this study about?

When someone is seriously ill or recovering from major surgery in an intensive care unit (ICU), their body is under immense strain. Around 1 in 10 patients in intensive care develop a fast, irregular heartbeat known as new-onset atrial fibrillation. This can happen for many reasons, including severe infections, changes in body salts, or the strong medications needed to support blood pressure.

Having an irregular heartbeat makes the heart work harder and can reduce blood flow around the body. It may increase the risk of complications such as heart failure or stroke, and it often means patients need to stay in hospital longer. Getting the heart back into its normal rhythm quickly and safely is an important part of critical care.

At the moment, NHS doctors use two main drug options to treat this condition: amiodarone and a group of medicines called beta-blockers. While both treatments are already approved and widely used, doctors do not yet have clear evidence showing which one works better, causes fewer unwanted side effects, or provides the best value for the NHS. This trial aims to answer that question so doctors can give future patients the best possible care.

Key takeaways

The ABBRUPT trial compares two standard NHS medicines (amiodarone vs beta-blockers) for irregular heart rhythms in intensive care.
Both treatments are already widely used, but this study aims to find out which one works best and is safest.
Patients are randomly assigned to one of the two medicines while in high-dependency or intensive care.
Participation involves routine hospital monitoring followed by two 30-minute check-in phone calls at 60 and 90 days.
Taking part is completely voluntary and will not disrupt normal medical care.

Who may be eligible?

This study is open to adults aged 16 and over who are receiving care in an intensive care unit or a high-dependency ward. To be considered, a patient must have developed a new, irregular heartbeat (atrial fibrillation) during their current hospital illness, and their medical team must feel that medicine is needed to treat it.

People cannot take part if they have already been treated for atrial fibrillation in the past with specific heart rhythm medicines or blood thinners. Patients are also unable to join if they have recently had heart surgery, have very low potassium levels in their blood, have an overactive thyroid, or take medications that clash with the trial drugs.

Because this study takes place in intensive care, doctors will carefully check a person's medical history and blood tests before confirming whether joining the trial is safe and appropriate.

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.

Aged 16 years or older
Currently being treated in an intensive care or high-dependency unit
Have developed a new episode of irregular heartbeat (atrial fibrillation) during this hospital stay
Doctor believes medication is needed to control the heart rhythm
Have not previously taken regular heart rhythm drugs or blood thinners for atrial fibrillation
Have not had recent heart surgery during this hospital stay

Answer every question to see your result.

What does participation involve?

Taking part in the study begins while the patient is in the hospital. A computer programme will randomly allocate the participant to receive either amiodarone or a beta-blocker chosen by their doctor. The medicine can be given through an intravenous drip or as tablets. Treatment continues until the patient's heart rhythm has stayed normal for at least 24 hours, after which the clinical team will decide whether to stop the medication.

Because patients in intensive care are already watched very closely, taking part does not require any extra blood tests or invasive procedures beyond standard care. Researchers will collect routine details from the patient's hospital records, including test results and the dates they move out of intensive care and leave the hospital.

After leaving the hospital, researchers will contact the participant for two brief 30-minute phone calls—once at around 60 days and once at around 90 days after joining the study. These calls are simply to ask how they are feeling and recovering. In total, a patient’s participation lasts for 90 days.

Potential risks and benefits

Participants might not experience any direct personal benefit from taking part, but the findings could greatly improve hospital care for future patients who develop an irregular heartbeat in intensive care. Both amiodarone and beta-blockers are already standard NHS treatments, meaning their known side effects—such as low blood pressure or a slower-than-intended heart rate—are well understood and closely monitored by the intensive care team. Taking part is entirely voluntary, and participants (or their families) can choose to withdraw from the study at any time without their normal medical care or relationship with hospital staff being affected.

Locations (47)

Lincoln County Hospital
Approximate
Lincoln, England
Royal Free London NHS Foundation Trust
City only
London, England
St Georges Hospital
City only
London, England
Musgrove Park Hospital (taunton)
Approximate
Taunton, England
Pinderfields Hospitals NHS Trust
City only
Wakefield, England
Sunderland Royal Hospital
Unverified
Sunderland, England
Watford General Hospital
Unverified
Watford, England
Bedford Hospital
Unverified
Bedford, England
Blackburn Royal Infirmary
Unverified
Blackburn, England
Blackpool Teaching Hospitals NHS Foundation Trust
Unverified
Blackpool, England
Royal Bournemouth Hospital
Unverified
Bournemouth, England
Poole
Unverified
Poole, England

Common questions

What is new-onset atrial fibrillation?

It is a fast, irregular heartbeat that starts suddenly in someone who previously had a normal heart rhythm, often triggered by severe illness, surgery, or stress on the body.

Are the study drugs experimental?

No. Both amiodarone and beta-blockers are established, fully licensed medicines that NHS doctors routinely use every day to treat irregular heart rhythms.

Can I choose which medicine I receive?

No. A computer assigns the treatment at random. This ensures the comparison between the two medicines is fair and scientifically sound.

Will taking part involve extra hospital visits?

No. All treatments and initial monitoring happen during the normal hospital stay. After discharge, follow-up simply consists of two phone calls at roughly two and three months.

What happens if I decide to leave the trial early?

You can leave the study at any point. Your decision will not change the quality of your care or the dedication of your medical team.

How to find out more

Lisa Holden

abbrupt@trials.bham.ac.uk +44 (0)121 414 7943 Official trial record

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