Delayed remodelling, a reduced need for ICDs?
Research type
Research Study
Full title
Delayed remodelling in severe LVSD, does this reduce the need for primary prevention ICDs? A feasibility study.
IRAS ID
308887
Contact name
Matthew Dewhurst
Contact email
Sponsor organisation
South Tees NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Heart failure (HF) is a significant health problem in the UK, causing premature death and unplanned hospitalisation. Patients with HF secondary to severely weakened heart muscle pump (HF with reduced ejection fraction, HFrEF) are at increased risk of sudden death due to electrical problems in the heart (arrhythmias). Patients are treated with a combination of (now) 4 medications to improve heart pump function and mitigate this risk. If heart pump function remains severely weak after 3 months of these medications at the highest tolerated doses (termed ‘optimal medical therapy’, OMT), then patients are considered for an Implantable Cardioverter-Defibrillator (ICD). This is an adjunctive treatment to OMT, which continues indefinitely. ICDs are specialised pacemakers, implanted under the skin. ICDs reduce the risk of sudden death, by delivering fast pacing and/or shocks to treat life-threatening electrical problems. However, ICDs carry risks of complications and inappropriate shocks. They are also expensive (~£15000) and evidence supporting their benefit is dated. Since the main ICD trials were published, new medications are used for HF, which further reduce the risk of life-threatening electrical problems, and may cause ‘delayed remodelling’ i.e.. these drugs cause continued improvement in heart pump function beyond 3 months such that an ICD would not be indicated.
We plan to study a cohort of UK patients with HF who have already had an ICD inserted to determine what proportion undergo delayed remodelling with longer tablet treatment and whether delaying decisions on ICD insertion would be safe (i.e. what proportion would miss out on the protective effect of an ICD if implant is delayed). We propose to investigate this by reassessing heart pump function after 12 months of OMT to see how many still meet the criteria for an ICD and how many have had therapy (ATP/shocks) from the ICD for life-threatening heart rhythms.
REC name
Wales REC 6
REC reference
22/WA/0317
Date of REC Opinion
12 Oct 2022
REC opinion
Favourable Opinion