Non-ischemic Dilated CardiomyopathyCMR-ICDNCT04558723
Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
A study testing ICD/CRT-D implantation in people with Non-ischemic Dilated Cardiomyopathy, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
Trial summary
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-ischemic Dilated Cardiomyopathy
- What is being tested?
- ICD/CRT-D implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 760 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jan 2021to Nov 2027
- 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
- NIDCM (idiopathic or familial)*
- LVEF ≤35% and presence of fibrosis on CMR
- Diagnostic CMR scan
- Age ≥18 years
- Written informed consent
- Ability to give informed consent
Who cannot join
- ICM [previous myocardial infarction, previous percutaneous coronary intervention]
- Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies [e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies [Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy].
- Myocarditis
- Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium)
- Severe renal insufficiency (creatinine clearance <30 mL/min)
- Current pacemaker or defibrillator in situ
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- Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD)
- Renal impairment defined as an eGFR <30 milliliters
- Age <18 years
- Patients presenting with pregnancy
- Patients without informed consent
- Participation in another randomized trial
- Life expectancy <2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universität zu Lübeck
Lübeck, Schleswig-Holstein, 23538
Ingo Eitel, Prof. Dr. med.
Thomas Stiermaier, Dr.med
About this study
Official title: Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.
Read the detailed description
The primary objective of this study is to evaluate the hypothesis that implantable cardioverter defibrillator (ICD) therapy would decrease the risk of death from any cause in comparison to optimal heart failure (HF) care without ICD insertion in patients with NIDCM, left ventricular ejection fraction (LVEF) ≤35% and presence of myocardial fibrosis on cardiac magnetic resonance (CMR) imaging.
- Conditions
- Non-ischemic Dilated Cardiomyopathy
- Being tested
- ICD/CRT-D implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD/CRT-D implantationOther
ICD/CRT-D implantation (if indicated)
| Study group | Role | What they receive |
|---|---|---|
| ICD group | Experimental | Patients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated. Receives: Other: ICD/CRT-D implantation |
| Optimal HF care group | No intervention | Patients receiving OMT and CRT pacemaker (CRT-P) implantation without a defibrillator if indicated. Patients without CRT indication will receive an ICM for detection of malignant VAs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death from any cause
Death from any causes during follow-up - after discharge.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start14 Jan 2021
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ischemic Dilated CardiomyopathyStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Ingo Eitel
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Ingo Eitel, University of Luebeck
- Investigators
- Ingo Eitel, Prof. Dr., Principal investigator, Medical Clinic II - University Heart Center Lübeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558723
- Sponsor's protocol ID
- 20-275
- Other IDs
- CMR-ICD-DZHK23
- Acronym
- CMR-ICD
- Status last verified
- May 2024
- First submitted
- 16 Sep 2020
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04558723
- Acronym / sponsor ID
- CMR-ICD / 20-275
- Conditions
- Non-ischemic Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 760 participants (estimated)
- Lead sponsor
- Prof. Dr. med. Ingo EitelUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 Sep 2020 (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.
Patients with diagnostic CMR images for assessment of LGE/fibrosis and evidence/presence of non-ischaemic myocardial fibrosis/scar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.
Detailed description
The primary objective of this study is to evaluate the hypothesis that implantable cardioverter defibrillator (ICD) therapy would decrease the risk of death from any cause in comparison to optimal heart failure (HF) care without ICD insertion in patients with NIDCM, left ventricular ejection fraction (LVEF) ≤35% and presence of myocardial fibrosis on cardiac magnetic resonance (CMR) imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICD group | Experimental | Other: ICD/CRT-D implantationPatients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated. |
| Optimal HF care group | No intervention | –Patients receiving OMT and CRT pacemaker (CRT-P) implantation without a defibrillator if indicated. Patients without CRT indication will receive an ICM for detection of malignant VAs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- NIDCM (idiopathic or familial)*
- LVEF ≤35% and presence of fibrosis on CMR
- Diagnostic CMR scan
- Age ≥18 years
- Written informed consent
Key exclusion criteria (13 listed)
- ICM [previous myocardial infarction, previous percutaneous coronary intervention]
- Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies [e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies [Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy].
- Myocarditis
- Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium)
- Severe renal insufficiency (creatinine clearance <30 mL/min)
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/CRT-D implantationICD/CRT-D implantation (if indicated) | Other | ICD group |
Primary outcome
Death from any cause
Time frame: Day 0
Death from any causes during follow-up - after discharge.
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 13 May 2024.
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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.
Ingo Eitel, Prof. Dr. principal investigator
Medical Clinic II - University Heart Center Lübeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD/CRT-D implantation in people with Non-ischemic Dilated Cardiomyopathy, run by Prof. Dr. med. Ingo Eitel at 1 site in Germany.
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 6 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: looking for participants now, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Contact Ingo Eitel, Prof. Dr. (+49 451 500 44501, ingo.eitel@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death from any cause (time frame: Day 0). 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 13 May 2024.