CompletedPhase IIInterventional

Targeted heart rate control using ivabradine to reduce disease in patients undergoing non-cardiac surgery

Major surgery places significant physical stress on the body. For older adults, this stress often causes the heart to beat much faster than normal. A rapid heart rate can increase the risk of heart damage and other complications, such as chest infections or kidney problems, during recovery. The FUNNY study tests whether a medicine called ivabradine can help. Ivabradine is an approved medicine that safely slows down the heartbeat without dropping blood pressure. Researchers want to see if taking it for a short time around surgery protects the heart and other vital organs. About 350 patients aged 55 and over will join. Participants are randomly chosen to take either ivabradine tablets or a dummy pill (placebo) twice a day for up to three days in hospital. Recovery is tracked with standard blood tests, heart checks, and a short phone call one month later.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Queen Mary University of London

Enrolment target

350

Start

21 Dec 2021

Estimated completion

06 Mar 2025

Patients undergoing elective or urgent non-cardiac surgery requiring general and/or regional anaesthesia with sedation

What is this study about?

More people than ever are undergoing major operations, including older adults who live with other long-term health conditions. While modern surgery is very safe, the stress of an operation can put unexpected pressure on the body. In the days following surgery, some patients develop complications such as lung infections, kidney strain, or subtle heart damage that can slow down recovery and lead to longer hospital stays.

Doctors have found that after surgery, the heart often beats much faster than usual. When the heart works overtime, it demands more oxygen and struggles to rest. This high heart rate is closely linked to heart strain and can also signal that other organs are under stress. Researchers believe that keeping the heart rate at a calm, steady speed during and immediately after an operation could help protect the entire body.

This trial is testing a medicine called ivabradine to see if it can prevent these problems. Ivabradine is already widely prescribed in the UK for chest pain and heart failure because it lowers the heart rate without lowering blood pressure. By studying 350 patients having major surgery, the research team hopes to find out whether a brief course of ivabradine reduces complications and helps people get back on their feet more quickly.

Key takeaways

The FUNNY study is testing whether ivabradine can gently lower heart rate to protect the heart during major surgery.
It is designed for adults aged 55 and over having non-heart operations lasting two hours or longer.
Participants take study tablets twice a day for up to three days while recovering in hospital.
Monitoring includes blood tests, heart checks, and a single follow-up phone call after 30 days.
Taking part is completely voluntary and does not change your planned surgical date.

Who may be eligible?

This study is open to adults aged 55 and over who are scheduled for planned or urgent surgery that does not involve the heart. The operation must be expected to take at least two hours under general anaesthetic or regional anaesthetic with sedation. Participants must also have high blood pressure (or be taking tablets for it) and have at least one health factor that puts extra stress on the heart during surgery.

You cannot join the study if you have a type of irregular heartbeat called atrial fibrillation, or if you have taken ivabradine within the last 30 days. Women who are able to become pregnant, or who are currently pregnant or breastfeeding, are also unable to take part.

People who have had an allergic reaction to ivabradine in the past, or who are already taking part in a clinical trial testing a similar type of medicine, cannot participate. Your hospital surgical team can review your medical records to confirm whether you meet all the criteria.

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.

I am aged 55 or over.
I am scheduled for an operation (not heart surgery) expected to take at least two hours.
I have high blood pressure or take tablets to control it.
I do not have an irregular heartbeat called atrial fibrillation.
I have not taken ivabradine in the past 30 days.
I am not pregnant, breastfeeding, or able to have children.

Answer every question to see your result.

What does participation involve?

If you decide to take part, a computer will randomly place you into one of two groups: one receives ivabradine tablets and the other receives a dummy pill (placebo). To keep the test fair, neither you nor your doctors will know which tablet you are taking. You will take the tablets twice a day, starting just before your operation and continuing for up to three days, or until you leave the hospital. The exact dose is matched to your heart rate before each tablet.

While you are in hospital, the research team will take small extra blood samples before your surgery and during the first three days to check for signs of heart strain. At some hospitals, you may also wear a portable heart and blood pressure monitor. These checks happen alongside your normal NHS hospital care. About 30 days after your operation, a researcher will call you at home for a short telephone catch-up to ask how you are feeling. Finally, at six months, the team will review your hospital records to complete their research notes. Taking part will not delay your surgery or keep you in hospital longer than planned.

Potential risks and benefits

Taking part may not help you directly, but the results could help make major surgery safer for patients in the future. Ivabradine is a well-known, approved medicine, but it can still cause side effects. The most common side effect is temporary changes in vision, such as brief flashes of light, halos, or brightness when moving between light and dark spaces. It can also cause a slower heart rate, dizziness, or mild headaches. Your medical team will monitor you closely around the clock while you are taking the tablets. Joining the study is entirely voluntary, and you are free to stop at any time without your routine NHS treatment or surgical care being affected.

Locations (3)

Royal London Hospital
Approximate
London, England
Newham University Hospital
Approximate
London, England
Whipps Cross Hospital
Approximate
London, England

Common questions

Will taking part delay my planned operation?

No. The study medication and extra checks are scheduled around your normal surgery time, so your operation will go ahead as planned.

What is a placebo?

A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It helps researchers know whether any improvements are truly caused by the study drug.

Do I have to pay for the study tablets or tests?

No. All trial medicines and tests are provided completely free of charge as part of the NHS research study.

What happens if my heart rate becomes too slow?

Nurses and doctors check your heart rate before every single dose. If your heart rate is already low, the dose will be adjusted or paused to keep you safe.

Can I leave the study if I change my mind?

Yes, you can leave the study at any point without giving a reason. Your standard hospital care and relationship with your doctors will stay exactly the same.

How to find out more

Tasnin Shahid

t.shahid@qmul.ac.uk +44 (0)20 3594 0352 Official trial record

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