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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sudden Cardiac Death
• Intervention / Treatment: Device: ICD implantation

• Study Type: Interventional
• Enrollment (Estimated): 720
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Nijmegen, Netherlands
    • Radboud University Medical Center
    • Contact: Cornelis P Allaart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: guideline directed medical therapy
Active Comparator: guideline directed medical therapy and ICD implantation	Device: ICD implantation; implantation of a non-resynchronisation ICD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sudden cardiac death		36 months
quality of life as measured by standardized questionnaires	score on Kansas City Cardiomyopathy Questionnaire (KCCQ) and EQ-5D-5L questionnaire	36 months
ventricular arhythmias	Number of participants with sustained ventricular arrhythmia or resuscitation from ventricular fibrillation	36 months
ICD-related complications	Numboer of participantis experiencing cardiac tamponade, pneumothorax or hematothorax, hematoma or bleeding, lead displacement, infection, arm deep vein thrombosis	36 months
ICD therapy	Number of patients experiencing appropriate ICD therapy (ATP or shock) or inappropriate ICD therapy	36 months

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Radboud University Medical Center; Amsterdam University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: magnetic resonance imaging; heart failure; implantable cardioverter defibrillator; non-ischemic dilated cardiomyopathy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Death; Heart Arrest; Death, Sudden; Pathological Conditions, Signs and Symptoms; Heart Failure; Death, Sudden, Cardiac
• Other Study ID Numbers: DUTCH-ICD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No