RecruitingNot ApplicableNCT04558723

Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy

Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy


Sponsor

Prof. Dr. med. Ingo Eitel

Enrollment

760 participants

Start Date

Jan 14, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses cardiac MRI to guide decisions about whether to implant a defibrillator (ICD) in patients with non-ischemic dilated cardiomyopathy (NIDCM) — a type of heart muscle disease where the heart becomes enlarged and weakened without a history of heart attacks or blocked arteries. Currently, defibrillators are often offered to all patients with severely reduced heart function, but cardiac MRI can reveal which patients have scar tissue (fibrosis) in their heart, which is a key risk factor for dangerous arrhythmias. This study tests whether using MRI to identify fibrosis leads to better-targeted use of defibrillators. The study is for adults aged 18 and older with a diagnosis of idiopathic or familial dilated cardiomyopathy, reduced ejection fraction (35% or below), and evidence of fibrosis on cardiac MRI. You may be eligible if: - You are 18 or older - You have been diagnosed with non-ischemic dilated cardiomyopathy (idiopathic or familial) - Your left ventricular ejection fraction is 35% or below - Your cardiac MRI shows evidence of fibrosis - You have not already had a pacemaker or defibrillator implanted You may NOT be eligible if: - Your heart disease is due to a prior heart attack or coronary artery disease - You have another cardiomyopathy type (e.g., hypertrophic, amyloid, sarcoid) - You have severe kidney disease (creatinine clearance below 30 mL/min) - You have a contraindication to MRI (e.g., pacemaker, claustrophobia, metal implants) - You are pregnant - Your life expectancy is less than 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERICD/CRT-D implantation

ICD/CRT-D implantation (if indicated)


Locations(1)

Universität zu Lübeck

Lübeck, Schleswig-Holstein, Germany

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NCT04558723


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