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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
| University of Southampton | OTHER |
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BRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries. Participants will be randomised into two groups. Half the participants will receive an Implantable Cardioverter-Defibrillator (ICD) and the other half will not. The aim of the study will be to compare all-cause mortality (death from any cause) between these two groups at 36 months, and longer-term to 10 years. The study has the potential to change international heart failure treatment guidelines and to improve how patients with this condition are managed.
Patients with Non-Ischemic Cardiomyopathy (NICM) have a higher risk of experiencing serious abnormal heart rhythms that might be life-threatening. Current guidelines recommend fitting a device that can correct these serious heart rhythms (Implantable Cardioverter-Defibrillator (ICD)). However, research studies have shown that 90% of patients who have an ICD will never use it because they won't experience any serious heart rhythms. A recent large trial (DANISH) of over one thousand patients with severe Non-Ischemic Cardiomyopathy has called the current guidelines into question. The trial concluded that for patients who received an ICD, there was no difference in the likelihood of dying when compared to patients that didn't have an ICD fitted. As a result, many doctors are choosing not to implant an ICD in patients with this type of heart failure, as they believe there is no overall survival benefit. However, there are clues that some patients with NICM may still benefit from an ICD, even though the headline results suggest they are not necessary. It's likely that it's the patients who are at increased risk of having a serious abnormal heart rhythm that stand to benefit from ICDs. But having an ICD fitted carries with it a significant risk of problems developing e.g. bleeding, infection, lead problems, and inappropriate shocks. These risks may not outweigh the benefits and it is this question which BRITISH will address. The study will randomly assign (like the toss of a coin), half the study participants to receive an ICD and the other half to no ICD.
Both groups will be followed up to decide whether having an ICD fitted reduces the chances of dying.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | ICD or CRTD fitted |
|
| Control | No Intervention | No ICD fitted (with Implantable Loop Recorder) or Cardiac Resynchronisation Therapy Pacemaker (CRTP) | |
| Registry | No Intervention | Usual medical care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) | Device | An ICD is a device that is implanted under the skin under a local anesthetic. It has a battery/generator component and leads which are fixed into the heart chambers. It has the ability to detect dangerous heart rhythms if they occur, and deliver a shock to treat this to help prevent sudden cardiac death. A CRTD is a pacemaker with a defibrillator function. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients alive | All-cause mortality | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health-related quality of life measured using KCCQ-12 | Short questionnaire including questions related to heart failure symptoms and how they affect daily activities | 3 years |
| Change in health-related quality of life measured using EQ-5D-5L |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abigail Jones | Contact | 023 8120 5154 | a.b.p.jones@soton.ac.uk | |
| Pedro Rodrigues | Contact | 023 8120 5154 | p.rodrigues@soton.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Flett | University Hospital Southampton NHS Foundation Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wycombe Hospital | Recruiting | High Wycombe | Buckinghamshire | HP11 2TT | United Kingdom |
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Eligible patients will be randomised in a controlled fashion into two arms (n=1252):
Arm A: ICD implantation Arm B: No ICD implantation Patients with no scar on CMR will be followed up in a registry (n=1252)
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|
Questionnaire consisting of 5 questions to evaluate a patients quality of life
| 3 years |
| Cardiovascular Death | Percentage of patients that have cardiovascular death | 3 years |
| Sudden cardiac death | Percentage of patients that have sudden cardiac death | 3 years |
| Aborted sudden cardiac death | Percentage of patients that have aborted sudden cardiac death | 3 years |
| Appropriate ICD Therapy | Percentage of patients that have appropriate ICD therapy | 3 years |
| Inappropriate ICD Therapy | Percentage of patients that have inappropriate ICD therapy | 3 years |
| Significant ventricular arrhythmias | Percentage of patients that have significant ventricular arrhythmias | 3 years |
| NYHA Status | Percentage of patients in each category | 3 years |
| Heart failure hospitalisations | Number of events | 3 years |
| Cardiac hospitalisations | Number of events | 3 years |
| Procedures related to implanted device | Number of events | 3 years |
| Percentage of patients alive | Mortality | At 5 and 10 years |
| Derriford Hospital | Recruiting | Plymouth | Devon | PL6 8DH | United Kingdom |
|
| Royal Bournemouth Hospital | Recruiting | Bournemouth | Dorset | BH7 7DW | United Kingdom |
|
| Durham & Darlington NHS Foundation Trust | Recruiting | Darlington | Durham | DL3 6HX | United Kingdom |
|
| Royal Sussex County Hospital | Recruiting | Brighton | East Sussex | BN2 5BE | United Kingdom |
|
| Essex Cardiothoracic Centre | Recruiting | Basildon | Essex | SS16 5NL | United Kingdom |
|
| James Paget University Hospitals NHS FT | Recruiting | Gorleston-on-Sea | Great Yarmouth | NR31 6LA | United Kingdom |
|
| Portsmouth Hospitals University NHS Trust | Recruiting | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
|
| Southampton Clinical Trials Unit | Not yet recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
|
| University Hospital Southampton NHS Foundation Trust | Recruiting | Southampton | Hampshire | SO16 6YD | United Kingdom |
|
| Kent & Canterbury Hospital | Recruiting | Canterbury | Kent | CT1 3NG | United Kingdom |
|
| Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust | Recruiting | Maidstone | Kent | ME16 9QQ | United Kingdom |
|
| Blackpool Victoria Hospiatal | Recruiting | Blackpool | Lancashire | FY3 8NR | United Kingdom |
|
| Liverpool Heart & Chest | Recruiting | Liverpool | Lancashire | L14 3PE | United Kingdom |
|
| Glenfield Hospital | Recruiting | Leicester | Leicestershire | LE3 9QP | United Kingdom |
|
| St Bartholomew's Hospital | Recruiting | London | London | EC1A 7BE | United Kingdom |
|
| Royal Free Hospital | Recruiting | London | London | NW3 2QG | United Kingdom |
|
| Guy's Hospital | Recruiting | London | London | SE1 9RT | United Kingdom |
|
| King's College Hospital | Recruiting | London | London | SE5 9RS | United Kingdom |
|
| Royal Brompton Hospital | Recruiting | London | London | SW3 6NP | United Kingdom |
|
| Hammersmith Hospital, Imperial College Healthcare NHS Trust | Recruiting | London | London | Wq12 0HS | United Kingdom |
|
| St George's Hospital | Recruiting | Tooting | London | SW17 0QT | United Kingdom |
|
| Fairfield General Hospital, Northern Care Alliance NHS FT | Recruiting | Manchester | Manchester | BL9 7TD | United Kingdom |
|
| Newcastle Freeman Hospital | Recruiting | Newcastle | Newcastle Upon Tyne | NE7 7DN | United Kingdom |
|
| The James Cook University Hospital | Recruiting | Middlesbrough | North Yorkshire | TS4 3BW | United Kingdom |
|
| Wansbeck General Hospital | Active, not recruiting | Ashington | Northumbria | NE63 9JJ | United Kingdom |
| Scarborough Hospital | Recruiting | Scarborough | Nortrh Yorkshire | YO12 6QL | United Kingdom |
|
| Nottingham City Hospital | Recruiting | Nottingham | Nottinghamshire | NG5 1PB | United Kingdom |
|
| The John Radcliffe Hospital | Recruiting | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
|
| Royal Infirmary of Edinburgh | Recruiting | Edinburgh | Scotland | EH16 4SA | United Kingdom |
|
| Musgrove Park Hospital | Active, not recruiting | Taunton | Somerset | TA1 5DA | United Kingdom |
| Northern General Hospital | Recruiting | Sheffield | South Yorkshire | S5 7AU | United Kingdom |
|
| University Hospital of North Tees | Recruiting | Hardwick | Stockton-on-Tees | TS19 8PE | United Kingdom |
|
| Frimley Park Hospital | Recruiting | Camberley | Surrey | GU16 7UJ | United Kingdom |
|
| Surrey & Sussex Healthcare NHS Trust | Recruiting | Redhill | Surrey | RH1 5RH | United Kingdom |
|
| University Hospital of Wales | Recruiting | Cardiff | Wales | CF14 4XW | United Kingdom |
|
| University Hospital Coventry | Recruiting | Coventry | Warwickshire | CV2 2DX | United Kingdom |
|
| New Cross Hospital | Recruiting | Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
|
| St Richards Hospital | Recruiting | Chichester | West Sussex | PO19 6SE | United Kingdom |
|
| Leeds General Infirmary | Recruiting | Leeds | West Yorkshire | LS1 3EX | United Kingdom |
|
| Pinderfields Hospital | Recruiting | Wakefield | West Yorkshire | WF1 4DG | United Kingdom |
|
| Worcestershire Royal Hospital | Recruiting | Worcester | Worcestershire | WR5 1DD | United Kingdom |
|
| Wythenshaw Hospital | Recruiting | Manchester | Wythenshaw | M23 9LT | United Kingdom |
|
| Castle Hill Hospital | Recruiting | Hull | Yorkshire | HU16 5JQ | United Kingdom |
|
| Royal Devon & Exeter Hospital | Recruiting | Exeter | EX2 5DW | United Kingdom |
|
| Morriston Hospital | Recruiting | Swansea | SA6 6NL | United Kingdom |
|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D004567 | Electrodes, Implanted |
| D019736 | Prostheses and Implants |
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