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New treatment option for Non-ischemic Dilated Cardiomyopathy
Official title Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy
ClinicalTrials.gov ID: NCT04558723
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- NIDCM (idiopathic or familial)\
- LVEF ≤35% and presence of fibrosis on CMR
- Diagnostic CMR scan
- Age ≥18 years
- Written informed consent
You likely can't join if
- ICM [previous myocardial infarction, previous percutaneous coronary intervention]
- Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative...
- Myocarditis
- Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy...
- Severe renal insufficiency (creatinine clearance \<30 mL/min)
- Current pacemaker or defibrillator in situ
See the full eligibility criteria
- 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
- 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...
- 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
- 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 assigned by chance trial
- Life expectancy \<2 years
The study team makes the final eligibility decision.
Where it's taking place
- Lübeck, Schleswig-Holstein, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lübeck, Schleswig-Holstein, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.