NCT07415642: DUTCH-ICD

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

Not yet recruiting NA Last updated 17 February 2026

What this trial tests

NA trial testing ICD implantation in Sudden Cardiac Death in 720 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
31 December 2032

31 December 2032

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	720
Start date	1 March 2026
Primary completion	31 December 2032
Estimated completion	31 December 2032
Sites	2 locations across Netherlands

Drugs / interventions tested

• ICD implantation

Conditions studied

• Sudden Cardiac Death — all drugs for Sudden Cardiac Death →

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Sudden Cardiac Death. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.