FUNNY
Research type
Research Study
Full title
Targeted heart rate control using the funny current inhibitor ivabradine to reduce morbidity in patients undergoing non-cardiac surgery: a phase IIa, triple blind, placebo controlled randomised trial
IRAS ID
1003561
Contact name
Gareth Ackland
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2020-002099-11
ISRCTN Number
ISRCTN12903789
Research summary
The development of serious medical problems after surgery (e.g. damage to the heart) can adversely affect the patient's care particularly in the
older more vulnerable population. A poor postoperative outcome not only delays patient recovery but poses longer-term health concerns such as
loss of mobility and independence. There is a clear and urgent need to improve perioperative care to effectively improve patient outcomes.
We know patients who are most vulnerable to developing complications often have problems with a specialised nerve that helps control their heart
beat. A key feature in these patients is a higher heart beat, which is strongly associated with heart damage and coincides with other organs of the
body not working normally. However current treatments that slow heart rate (e.g. beta-blockers) can result in further damage being done because
of indirect effects caused by
these drugs on blood pressure and other functions.
Our aim is to establish whether the specific lowering of a patient’s heart rate during their perioperative care (the care before, during and after
surgery) will protect them from damage to the heart and reduce the development of further complications. In this trial, the drug ivabradine will be
used which slows heart rate only. We will invite 350 patients having surgery that does not involve to take part. We will randomly allocate them (like
a coin toss) to receive ivabradine tablets or placebo tablets for a maximum of three days from the day of surgery. After surgery, researchers who
don't know which patients have been given ivabradine will measure their safety and well being.REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0069
Date of REC Opinion
4 Jun 2021
REC opinion
Further Information Favourable Opinion