Not Yet RecruitingNot Applicable

Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)

Netherlands720 participantsStarted 2026-03-01

Plain-language summary

Research questions: The value of primary prevention implantable cardioverter-defibrillator implantation (ICD) therapy in patients with non-ischemic cardiomyopathy (NICM) is under debate. Improved risk stratification is needed to select patients at highest risk. Hypotheses: 1. In NICM patients with CMR detected myocardial fibrosis, ICD implantation reduces all-cause mortality compared to guideline-directed medical therapy (GDMT) only. 2. Myocardial fibrosis assessed by cardiac MRI (CMR) can be used to stratify patients according to risk for sudden cardiac death. Study design: 1. Patients with myocardial fibrosis: Randomized controlled trial (RCT). 2. Patients without myocardial fibrosis: Prospective registry. Study population: Patients with non-ischemic cardiomyopathy with LVEF \<35% after at least 3 months of guideline-directed medical therapy (GDMT). Intervention: ICD implantation. Main study parameters/endpoints: primary endpoint: all-cause mortality. Secondary endpoints include: patient clinical status, quality of life, sudden cardiac death, ventricular arrhythmias, ICD complications and ICD therapy Nature and extent of the burden and risks associated with participation, benefit and group relatedness: All ICDs that are implanted in the study are standard devices that are used in daily clinical practice. Patients who are randomized to ICD implantation will be subjected to the risk of perioperative and long-term complications but will be partly protected against death from ventricular arrhythmias. Patients randomized to no ICD implantation will not be protected against the residual risk of sudden cardiac death but are not subjected to complications from ICD implantation and possible subsequent complications. The only additional burden for patients is completing quality-of-life questionnaires, all hospital visits are for routine follow-up.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Non-ischemic cardiomyopathy * Left ventricular late gadolinium enhancement on MRI, but not hinge-point fibrosis * Left ventricular ejection fraction \<35% on any modality * Functional class NYHA I-III * At least 3 months optimal medical treatment for heart failure Exclusion Criteria: * Indication for cardiac resynchronization therapy * Functional class NYHA IV * Typical ischemic scar tissue on CMR * Amyloidosis, sarcoidosis, hypertrophic cardiomyopathy, complex congenital heart disease * high-risk mutations causing DCM * Patient on waiting list for heart transplantation * Left ventricular assist device present * Severe valve disease * Secondary prevention indication for ICD * Untreated cardiac ischemia * High competing risk of death (\>35% in 1 year according to HFmetascore) * Active chemotherapy for cancer * Severe renal failure with dialysis expected within 3 years

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

all-cause mortality

Timeframe: 36 months

Trial details

NCT IDNCT07415642

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2032-12-31

View on ClinicalTrials.gov More Sudden Cardiac Death trials