NCT07415642

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
79mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Dec 2032

First Submitted

Initial submission to the registry

January 6, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2032

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

6.8 years

First QC Date

January 6, 2026

Last Update Submit

February 9, 2026

Conditions

Sudden Cardiac Death

Keywords

implantable cardioverter defibrillatornon-ischemic dilated cardiomyopathymagnetic resonance imagingheart failure

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    36 months

Secondary Outcomes (5)

  • sudden cardiac death

    36 months

  • quality of life as measured by standardized questionnaires

    36 months

  • ventricular arhythmias

    36 months

  • ICD-related complications

    36 months

  • ICD therapy

    36 months

Study Arms (2)

guideline directed medical therapy

NO INTERVENTION

guideline directed medical therapy and ICD implantation

ACTIVE COMPARATOR
Device: ICD implantation

Interventions

ICD implantationDEVICE

implantation of a non-resynchronisation ICD

guideline directed medical therapy and ICD implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center Groningen

Groningen, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Death, Sudden, CardiacHeart Failure

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

February 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 31, 2032

Study Completion (Estimated)

December 31, 2032

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

NL(2)