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Left Ventricular Structural Predictors of Sudden Cardiac Death

NCT01076660 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2026-01-20

No results posted yet for this study

Summary

Sudden cardiac death (SCD) poses a significant health care challenge with high annual incidence and low survival rates. Implantable cardioverter defibrillators (ICDs) prevent SCD in patients with poor heart function. However, the critical survival benefit afforded by the devices is accompanied by short and long-term complications and a high economic burden. Moreover, in using current practice guidelines of reduced heart function, specifically left ventricular ejection fraction (LVEF)≤35%, as the main determining factor for patient selection, only a minority of patients actually benefit from ICD therapy (\<25% in 5 years). There is an essential need for more robust diagnostic approaches to SCD risk stratification.

This project examines the hypothesis that structural abnormalities of the heart itself, above and beyond global LV dysfunction, are important predictors of SCD risk since they indicate the presence of the abnormal tissue substrate required for the abnormal electrical circuits and heart rhythms that actually lead to SCD. Information about the heart's structure will be obtained from cardiac magnetic resonance imaging and used in combination with a number of other clinical risk factors to see if certain characteristics can better predict patients at risk for SCD.

Conditions

  • Ischemic Cardiomyopathy
  • Nonischemic Cardiomyopathy

Sponsors & Collaborators

  • Donald W. Reynolds Foundation

    collaborator OTHER

  • Christiana Care Health Services

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Katherine Wu, MD · Johns Hopkins University

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2028-06-30
Completion
2030-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01076660 on ClinicalTrials.gov