RSA-PACE V1.0
Research type
Research Study
Full title
Respiratory sinus arrhythmia pacing post-CABG surgery in patients with HFrEF
IRAS ID
315761
Contact name
Susan Peirce
Contact email
Sponsor organisation
Ceryx Medical Australia Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
CED251, CEDAR; CARD 53420, NIHR CRN
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
Heart failure is a common condition which means that the heart is less able to pump blood around the body. It is a long-term condition with a significant impact on patients' ability to carry out activities and it also reduces life expectancy.
Respiratory sinus arrhythmia (RSA) is a normal variation in the heart rate; increasing when you breathe in and slowing down when you breathe out. RSA is reduced in heart failure. In experiments in animals with heart failure, restoring RSA with a heart pacemaker for a few days substantially improved their heart's ability to pump. This new study looks at whether we can use a temporary pacemaker to restore RSA in humans safely, and whether this has a similar effect.
When blood vessels that supply the heart muscle get blocked patients may have a coronary artery bypass graft (CABG) operation. After the operation, patients sometimes have irregular heart rhythms, so temporary pacing wires are attached to the heart and an external pacemaker may be used.
In patients with heart failure who have just had a CABG operation we will compare the effect of having the new RSA-type pacing, against having standard cardiac pacing (at a fixed heart rate). Patients will be randomly allocated to one of these treatments and will have their heart paced for several days while they are in hospital. Patients will wear oxygen tubing to measure their breathing and control the RSA-type pacing.
We will test whether the device can deliver the new RSA-type pacing to the heart and whether it is as safe as ordinary pacing. We will also test whether it improves the function of the heart and if any improvements fade away a few days after the pacing has stopped.The trial will take place in cardiac specialist centres in 3 locations, in Cardiff, Swansea, and Bristol.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
24/YH/0110
Date of REC Opinion
11 Jun 2024
REC opinion
Favourable Opinion