Role of the implantable cardioverter-defibrillator in non-ischemic heart failure

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 - DUTCH-ICD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58026

Enrollment

1440

Registered

2025-02-27

Start date

2026-07-15

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DCM, NICM heart failure

Interventions

Intervention: ICD implantation. Usual care/comparison: OMT.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Non-ischemic cardiomyopathyLeft ventricular late gadolinium enhancement on cMRI, but not hinge-point fibrosisLeft ventricular ejection fraction <35% on any modalityFunctional class NYHA I-IIIAt least 3 months optimal medical treatment for heart failure

Exclusion criteria

Exclusion criteria: Functional class NYHA IVTypical ischemic scar tissue on cMRIAmyloidosis, sarcoidosis, hypertrophic cardiomyopathy, complex congenital heart diseasehigh-risk mutations causing DCMPatient on waiting list for heart transplantationLeft ventricular assist device presentSevere valve diseaseSecondary prevention indication for ICDUntreated cardiac ischemiaHigh competing risk of death (>35% in 1 year according to HFmetascore)Active chemotherapy for cancerSevere renal failure with dialysis expected within 3 years

Design outcomes

Primary

Measure	Time frame
All-cause mortality.	—

Secondary

Measure	Time frame
sudden cardiac death or resuscitationappropriate or inappropriate ICD therapysustained VT or VFheart failure or cardiovascular hospitalizationICD-related interventionFunctional NYHA classquality of life	—

Countries

Netherlands

Contacts

Public ContactAH Maass

Universitair Medisch Centrum Groningen

a.h.maass@umcg.nl0503616161

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026