Defibrillator implants in people with non-ischemic dilated cardiomyopathy and scarring on heart MRI
Tests whether an implanted defibrillator helps adults with weakened heart muscle and MRI-detected scarring.
Plain-language title generated from the registry record
Registry title: Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)
Key facts
- Where
- Groningen and Nijmegen, NetherlandsSee the 2 sites
Where in Netherlands
- University Medical Center GroningenGroningen, NetherlandsNo longer taking part
- Radboud University Medical CenterNijmegen, NetherlandsNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT07415642
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
Using Cardiovascular Magnetic Resonance Identified Fibrosis to Assess Sudden Cardiac Death Risk in Patients With Non-ischemic Dilated Cardiomyopathy and the Unknown Therapeutic Risk Reduction of Contemporary Heart Failure Medication and Implantable Cardioverter-Defibrillators
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.
Inclusion: 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: Indication for cardiac resynchronization therapy; Amyloidosis, sarcoidosis, hypertrophic cardiomyopathy, complex congenital heart disease; Patient on waiting list for heart transplantation; Severe valve disease; Untreated cardiac ischemia; Active chemotherapy for cancer; Severe renal failure with dialysis expected within 3 years; Functional class NYHA IV; Typical ischemic scar tissue on CMR; high-risk mutations causing DCM; Left ventricular assist device present; Secondary prevention indication for ICD; High competing risk of death (>35% in 1 year according to HFmetascore).