Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a tiny implant save thousands of heart failure patients?

NCT ID NCT05568069

Disease control Sponsor: University Hospital Southampton NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether an implantable defibrillator (ICD) helps people with a certain type of heart failure (non-ischemic cardiomyopathy) live longer. About 2,500 participants will be randomly assigned to receive an ICD or not, and their survival will be tracked for up to 10 years. The goal is to see if the device, which shocks the heart back into rhythm if it becomes dangerous, actually reduces deaths in this group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
What this could lead to
If this trial succeeds, it could show that ICDs save lives in people with non-ischemic heart failure, leading to updated treatment guidelines and better patient care.
What could go wrong
This is a large, late-stage trial, but it is still possible that ICDs do not improve survival in this specific group. There are also risks from the implant procedure, such as infection or device malfunction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,504 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Feb 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging 2. LV scar on routine CMR (patient without scar can enter the registry) 3. 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 medical therapy (OMT) as recommended by National Institute for Health and Care Excellence (NICE) 4. Able and willing to provide informed consent Exclusion Criteria: 1. New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT) 2. Acute decompensated heart failure 3. Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or ICD) 4. 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 LVEF ≤35% and a small amount of ischemic LGE (i.e. an infarct out of keeping with the amount of LV dysfunction) will not be excluded (so-called dual pathology patients) 5. Known diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, or hypertrophic cardiomyopathy (diseases in which there are specific guidelines regarding defibrillator therapy) 6. Known Lamin gene mutation or a positive family history of a Lamin gene mutation 7. Valve disease is considered likely to require surgery during the 3 years follow-up period 8. Complex congenital heart disease 9. Any secondary prevention ICD indication 10. Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device 11. Clinically apparent myocardial ischemia which requires revascularization 12. Intracardiac mass which requires surgery 13. Active endocarditis 14. Active Septicaemia 15. Pregnancy 16. Life expectancy \<2 years secondary to any other cause (i.e. malignancy) 17. Active treatment with chemotherapy 18. Severe renal failure (GFR \<30) 19. Actively participating in another study without prior agreement between both Chief Investigators

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Heart failure are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

heart failure intrinsic cardiomyopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    RECRUITING

    Aberdeen, Scotland, AB25 2ZN, United Kingdom

  • Blackpool Victoria Hospiatal

    RECRUITING

    Blackpool, Lancashire, FY3 8NR, United Kingdom

  • Castle Hill Hospital

    RECRUITING

    Hull, Yorkshire, HU16 5JQ, United Kingdom

  • Derriford Hospital

    RECRUITING

    Plymouth, Devon, PL6 8DH, United Kingdom

  • Durham & Darlington NHS Foundation Trust

    RECRUITING

    Darlington, Durham, DL3 6HX, United Kingdom

  • Essex Cardiothoracic Centre

    RECRUITING

    Basildon, Essex, SS16 5NL, United Kingdom

  • Fairfield General Hospital, Northern Care Alliance NHS FT

    RECRUITING

    Manchester, Manchester, BL9 7TD, United Kingdom

  • Frimley Park Hospital

    RECRUITING

    Camberley, Surrey, GU16 7UJ, United Kingdom

  • Glenfield Hospital

    RECRUITING

    Leicester, Leicestershire, LE3 9QP, United Kingdom

  • Guy's Hospital

    RECRUITING

    London, London, SE1 9RT, United Kingdom

  • Hammersmith Hospital, Imperial College Healthcare NHS Trust

    RECRUITING

    London, London, Wq12 0HS, United Kingdom

  • James Paget University Hospitals NHS FT

    RECRUITING

    Gorleston-on-Sea, Great Yarmouth, NR31 6LA, United Kingdom

  • Kent & Canterbury Hospital

    RECRUITING

    Canterbury, Kent, CT1 3NG, United Kingdom

  • King's College Hospital

    RECRUITING

    London, London, SE5 9RS, United Kingdom

  • Leeds General Infirmary

    RECRUITING

    Leeds, West Yorkshire, LS1 3EX, United Kingdom

  • Liverpool Heart & Chest

    RECRUITING

    Liverpool, Lancashire, L14 3PE, United Kingdom

  • Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust

    RECRUITING

    Maidstone, Kent, ME16 9QQ, United Kingdom

  • Morriston Hospital

    RECRUITING

    Swansea, SA6 6NL, United Kingdom

  • Musgrove Park Hospital

    ACTIVE_NOT_RECRUITING

    Taunton, Somerset, TA1 5DA, United Kingdom

  • New Cross Hospital

    RECRUITING

    Wolverhampton, West Midlands, WV10 0QP, United Kingdom

  • Newcastle Freeman Hospital

    RECRUITING

    Newcastle, Newcastle Upon Tyne, NE7 7DN, United Kingdom

  • Northern General Hospital

    RECRUITING

    Sheffield, South Yorkshire, S5 7AU, United Kingdom

  • Nottingham City Hospital

    RECRUITING

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Pinderfields Hospital

    RECRUITING

    Wakefield, West Yorkshire, WF1 4DG, United Kingdom

  • Portsmouth Hospitals University NHS Trust

    RECRUITING

    Portsmouth, Hampshire, PO6 3LY, United Kingdom

  • Royal Bournemouth Hospital

    RECRUITING

    Bournemouth, Dorset, BH7 7DW, United Kingdom

  • Royal Brompton Hospital

    RECRUITING

    London, London, SW3 6NP, United Kingdom

  • Royal Devon & Exeter Hospital

    RECRUITING

    Exeter, EX2 5DW, United Kingdom

  • Royal Free Hospital

    RECRUITING

    London, London, NW3 2QG, United Kingdom

  • Royal Infirmary of Edinburgh

    RECRUITING

    Edinburgh, Scotland, EH16 4SA, United Kingdom

  • Royal Sussex County Hospital

    RECRUITING

    Brighton, East Sussex, BN2 5BE, United Kingdom

  • Scarborough Hospital

    RECRUITING

    Scarborough, Nortrh Yorkshire, YO12 6QL, United Kingdom

  • Southampton Clinical Trials Unit

    NOT_YET_RECRUITING

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • St Bartholomew's Hospital

    RECRUITING

    London, London, EC1A 7BE, United Kingdom

  • St George's Hospital

    RECRUITING

    Tooting, London, SW17 0QT, United Kingdom

  • St Richards Hospital

    RECRUITING

    Chichester, West Sussex, PO19 6SE, United Kingdom

  • Surrey & Sussex Healthcare NHS Trust

    RECRUITING

    Redhill, Surrey, RH1 5RH, United Kingdom

  • The James Cook University Hospital

    RECRUITING

    Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom

  • The John Radcliffe Hospital

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • University Hospital Coventry

    RECRUITING

    Coventry, Warwickshire, CV2 2DX, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • University Hospital of North Tees

    RECRUITING

    Hardwick, Stockton-on-Tees, TS19 8PE, United Kingdom

  • University Hospital of Wales

    RECRUITING

    Cardiff, Wales, CF14 4XW, United Kingdom

  • Wansbeck General Hospital

    ACTIVE_NOT_RECRUITING

    Ashington, Northumbria, NE63 9JJ, United Kingdom

  • Worcestershire Royal Hospital

    RECRUITING

    Worcester, Worcestershire, WR5 1DD, United Kingdom

  • Wycombe Hospital

    RECRUITING

    High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom

  • Wythenshaw Hospital

    RECRUITING

    Manchester, Wythenshaw, M23 9LT, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.