Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy

Launched by FLINDERS UNIVERSITY · Jun 20, 2019

Keywords

ClinConnect Summary

The CMR GUIDE DCM trial is a research study looking at how well an implantable cardiac defibrillator (ICD) works for patients with a specific type of heart condition called dilated cardiomyopathy. This condition means that the heart's main pumping chamber, called the left ventricle, is not working properly, which can lead to serious health issues. In this trial, 954 participants will be randomly selected to either receive an ICD, which can help prevent life-threatening heart rhythms, or an implantable loop recorder (ILR) that monitors heart activity. Patients will be followed for several years to see how well these devices work.

To be eligible for this trial, participants need to be at least 18 years old and diagnosed with non-ischemic dilated cardiomyopathy, meaning their heart issues are not caused by blocked arteries. They must also have a specific level of heart function, indicated by a measurement called the left ventricular ejection fraction, which should be below 45%. Additionally, patients should be taking certain heart medications at their highest tolerated doses. Those with other heart conditions or severe health issues, such as significant kidney problems or a life expectancy of less than one year, will not be included. Participants can expect regular check-ups over the next few years to monitor their health and the performance of the devices.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age greater than/equal to 18 years old
• • Non-ischemic cardiomyopathy of dilated type
• • Left Ventricular Ejection Fraction \< 45%
• • Able and willing to comply with all pre, post and follow-up testing and requirements
• • On maximum tolerated doses of angiotensin converting enzyme (ACE) inhibitors (or Angiotensin Receptor Blockers(ARB) or Neprilysin Inhibitors) and Beta Blockers
• Exclusion Criteria:
• • 1. Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant Epicardial CAD on Angiography)
• • 2. Hypertrophic Cardiomyopathy
• • 3. Cardiomyopathy related to sarcoidosis
• • 4. Arrhythmogenic Right Ventricular Dysplasia
• • 5. Standard LGE CMR contraindications (e.g. severe claustrophobia, metal)
• • 6. Currently implanted permanent pacemaker and/or pacemaker/ICD lead
• • 7. Clinical indication for ICD or pacemaker or Cardiac Resynchronisation Therapy
• • 8. Contraindications to intravenous Gadolinium
• • 9. Severe renal insufficiency (eGFR\< 45mls/min/1.73m2 )
• • 10. New York Heart Association Heart Failure functional class IV
• • 11. Conditions associated with life expectancy \<1 year
• • 12. Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception