Clinical Trials Logo

Clinical Trial Summary

This study is an observational study to determine predictors of sudden cardiac death or appropriate ICD therapy in patients with non-ischemic cardiomyopathy. Patients will be followed for 36 months for the occurrence of sudden cardiac death


Clinical Trial Description

Non-ischemic cardiomyopathy (NICM) comprises almost one half of the congestive heart failure (CHF) population NICM portends an increased risk for hospitalizations due to CHF as well as death. This population is also at high risk for the occurrence of tachyarrhythmias and has a high incidence of sudden cardiac death (SCD). The risk of SCD can be lowered by the placement of an (intercardioverter defibrillator) ICD. The implantation of an ICD significantly reduces the risk of SCD in patients with NICM and a left ventricular ejection fraction (LVEF) of 35 percent or less. However the implantation of an ICD has short term as well as long term risk associated with it. Many patients receive an ICD who never go on to have appropriate therapy. Current American College of Cardiology/American Heart Association (ACC/AHA) guidelines state that "ICD therapy is recommended for primary prevention of SCD to reduce total mortality in selected patients with nonischemic dilated cardiomyopathy (DCM) or ischemic heart disease at least 40 days post-myocardial infarction(MI) with LVEF of 35% or less and New York Heart Association (NYHA) class II or III symptoms on chronic guideline-directed medical therapy(GDMT), who have reasonable expectation of meaningful survival for more than 1 year." There is a need for new criteria for ICD placement in patients with NICM that are more sensitive and specific than current guidelines.

Delayed enhancement imaging on cardiac magnetic resonance imaging (CMR) has become the gold standard for myocardial scar/necrosis detection. The presence of late gadolinium enhancement (LGE) on CMR which corresponds to myocardial scarring or fibrosis has been shown to be a predictor of adverse outcomes in ischemic cardiomyopathy. There have been few studies evaluating the significance of LGE in patients with NICM, however the results are promising. The presence of LGE has been associated with the incidence of inducible tachycardia by electrophysiology (EP) testing in patients with NICM. LGE has also been associated with an increased risk of morbidity and mortality in a general NICM population.

The investigators plan to enroll patients with NICM with an EF ≤ 40% who have been referred for CMR and follow them for the composite endpoint of sudden cardiac death or an appropriate ICD therapy (Antitachycardic pacing or shock). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02657967
Study type Observational [Patient Registry]
Source NYU Langone Health
Contact
Status Completed
Phase
Start date May 2015
Completion date October 24, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Not yet recruiting NCT01447069 - Use of Beta-agonists in Stable Severe Congestive Heart Failure N/A
Recruiting NCT05572957 - LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB N/A
Enrolling by invitation NCT03293381 - Electrogram-Guided Myocardial Advanced Phenotyping
Recruiting NCT03830957 - Efficacy and Safety of Ivabradine to Reduce Heart Rate Prior to Coronary CT-angiography in Advanced Heart Failure: Comparison With β-Blocker N/A
Suspended NCT03071653 - Left Cardiac Sympathetic Denervation for Cardiomyopathy Feasibility Pilot Study Phase 2
Terminated NCT03925324 - Serial Infusions of Allogeneic Mesenchymal Stem Cells in Cardiomyopathy Patients With Left Ventricular Assist Device Phase 2
Recruiting NCT05855135 - Assessment of Combined CCM and ICD Device in HFrEF N/A
Completed NCT04325594 - The Application of the Umbilical Cord Mesenchymal Stem Cells in the Complex Treatment of Non-ischemic Heart Failure Phase 2
Active, not recruiting NCT01643330 - A Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure Phase 2
Terminated NCT01935622 - Safety and Efficacy of Doxycycline in Patients With Non-Ischemic Cardiomyopathy Phase 2
Completed NCT03509441 - Early MRI Detection of Myocardial Deterioration as a Preventive, Disease Staging, and Prognostic Biomarker in Insulin Resistance
Completed NCT04607265 - Sudden Death Stratification
Withdrawn NCT01787851 - Study of the Acute Effects of Triheptanoin in Heart Failure Phase 1/Phase 2
Terminated NCT01966887 - AAV1-CMV-Serca2a GENe Therapy Trial in Heart Failure Phase 2
Recruiting NCT06243653 - Relationship Between Coronary Microvascular Dysfunction and Improvement of Left Ventricular Systolic Function in Patients With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology
Recruiting NCT04265040 - DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies
Terminated NCT02346422 - A Phase 1/2 Study of High-dose Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure Phase 1/Phase 2