Sudden Cardiac DeathDUTCH-ICDNCT07415642
Dilated Cardiomyopathy - Unknown Therapeutic Risk Reduction by Contempary Medication and Implantable Cardioverter-Defibrillators (DUTCH-ICD)
A study testing ICD implantation in people with Sudden Cardiac Death, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- ICD implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Mar 2026to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites
University Medical Center Groningen
Groningen
Radboud University Medical Center
Nijmegen
Cornelis P Allaart
About this study
Official title: 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.
Read more
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.
- Conditions
- Sudden Cardiac Death
- Being tested
- ICD implantation
- Keywords
- implantable cardioverter defibrillator, non-ischemic dilated cardiomyopathy, magnetic resonance imaging, heart failure
- Medical subject headings
- Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD implantationDevice
implantation of a non-resynchronisation ICD
| Study group | Role | What they receive |
|---|---|---|
| guideline directed medical therapy | No intervention | Not described |
| guideline directed medical therapy and ICD implantation | Active comparator | Not described Receives: Device: ICD implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 36 months
Secondary outcomes (5)
sudden cardiac death
Measured: 36 months
quality of life as measured by standardized questionnaires
score on Kansas City Cardiomyopathy Questionnaire (KCCQ) and EQ-5D-5L questionnaire
Measured: 36 months
ventricular arhythmias
Number of participants with sustained ventricular arrhythmia or resuscitation from ventricular fibrillation
Measured: 36 months
ICD-related complications
Numboer of participantis experiencing cardiac tamponade, pneumothorax or hematothorax, hematoma or bleeding, lead displacement, infection, arm deep vein thrombosis
Measured: 36 months
ICD therapy
Number of patients experiencing appropriate ICD therapy (ATP or shock) or inappropriate ICD therapy
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam University Medical Center, Radboud University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415642
- Sponsor's protocol ID
- DUTCH-ICD
- Acronym
- DUTCH-ICD
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07415642
- Acronym / sponsor ID
- DUTCH-ICD / DUTCH-ICD
- Conditions
- Sudden Cardiac Death
- Keywords
- implantable cardioverter defibrillator, non-ischemic dilated cardiomyopathy, magnetic resonance imaging, heart failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Amsterdam University Medical Center, Radboud University Medical Center
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| guideline directed medical therapy | No intervention | – |
| guideline directed medical therapy and ICD implantation | Active comparator | Device: ICD implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD implantationimplantation of a non-resynchronisation ICD | Device | guideline directed medical therapy and ICD implantation |
Primary outcome
all-cause mortality
Time frame: 36 months
5 secondary outcomes
sudden cardiac death
Time frame: 36 months
quality of life as measured by standardized questionnaires
Time frame: 36 months
ventricular arhythmias
Time frame: 36 months
ICD-related complications
Time frame: 36 months
ICD therapy
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD implantation in people with Sudden Cardiac Death, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.