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New treatment option for Heart Failure
Official title RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
ClinicalTrials.gov ID: NCT05568069
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging
- LV scar on routine CMR (patient without scar can enter the registry)
- New York Heart Association (NYHA) Heart Failure (HF) functional class I-III and severely impaired left ventricular function (LVEF ≤ 35% on any...
- Able and willing to provide informed consent
You likely can't join if
- New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT)
- Acute decompensated heart failure
- Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or ICD)
- Ischemic cardiomyopathy (ICM) is defined as segmental wall motion abnormalities or wall thinning in a particular coronary territory with...
- Known diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, or hypertrophic cardiomyopathy (diseases in which there...
- Known Lamin gene mutation or a positive family history of a Lamin gene mutation
See the full eligibility criteria
- A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging
- LV scar on routine CMR (patient without scar can enter the registry)
- New York Heart Association (NYHA) Heart Failure (HF) functional class I-III and severely impaired left ventricular function (LVEF ≤ 35% on any imaging modality) after a minimum of 3 months of treatment with optimal...
- Able and willing to provide informed consent
- New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT)
- Acute decompensated heart failure
- Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or ICD)
- Ischemic cardiomyopathy (ICM) is defined as segmental wall motion abnormalities or wall thinning in a particular coronary territory with subendocardial or transmural late gadolinium enhancement (LGE). Patients with an...
- Known diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, or hypertrophic cardiomyopathy (diseases in which there are specific guidelines regarding defibrillator therapy)
- Known Lamin gene mutation or a positive family history of a Lamin gene mutation
- Valve disease is considered likely to require surgery during the 3 years follow-up period
- Complex congenital heart disease
- Any secondary prevention ICD indication
- Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device
- Clinically apparent myocardial ischemia which requires revascularization
- Intracardiac mass which requires surgery
- Active endocarditis
- Active Septicaemia
- Pregnancy
- Life expectancy \<2 years secondary to any other cause (i.e. malignancy)
- Active treatment with chemotherapy
- Severe renal failure (GFR \<30)
- Actively participating in another study without prior agreement between both Chief Investigators
The study team makes the final eligibility decision.
Where it's taking place
- High Wycombe, Buckinghamshire, United Kingdom
- Plymouth, Devon, United Kingdom
- Bournemouth, Dorset, United Kingdom
- Darlington, Durham, United Kingdom
- Brighton, East Sussex, United Kingdom
- Basildon, Essex, United Kingdom
- Gorleston-on-Sea, Great Yarmouth, United Kingdom
- Portsmouth, Hampshire, United Kingdom
- Southampton, Hampshire, United Kingdom
- Canterbury, Kent, United Kingdom
- Maidstone, Kent, United Kingdom
- Blackpool, Lancashire, United Kingdom
- Liverpool, Lancashire, United Kingdom
- Leicester, Leicestershire, United Kingdom
- London, London, United Kingdom
- Tooting, London, United Kingdom
- Manchester, Manchester, United Kingdom
- Newcastle, Newcastle Upon Tyne, United Kingdom
- Middlesbrough, North Yorkshire, United Kingdom
- Ashington, Northumbria, United Kingdom
+ 21 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include High Wycombe, Buckinghamshire, United Kingdom; Plymouth, Devon, United Kingdom; Bournemouth, Dorset, United Kingdom; Darlington, Durham, United Kingdom; Brighton, East Sussex, United Kingdom; Basildon, Essex, United Kingdom and 35 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.