Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT01076660

Conditions

Ischemic Cardiomyopathy

Nonischemic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT01076660

Start date

Oct, 2003

Status verified date

Jan, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • LVEF≤35%, referred clinically for ICD insertion for primary prevention purposes (i.e. no prior history of sustained ventricular arrhythmias)
  • Between the ages of 21 and 80 years old
  • Permission of the patient's clinical attending physician

Exclusion Criteria:

  • Patients who refuse or are unable to give consent.
  • Individuals with contraindications to MRI (i.e. implanted metallic objects such as pre-existing cardiac pacemakers, cerebral clips or indwelling metallic projectiles)
  • Minors.
  • Pregnant women.
  • NYHA Class IV heart failure.
  • Chronic renal insufficiency with creatinine clearance<60 ml/min; acute renal insufficiency of any severity
  • Claustrophobia
  • Prior adverse reaction to gadolinium-based contrast

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Composite SCD outcomes [ Time Frame: Every 6 months for 5 years ]

Central Contacts and Locations

Central contacts

Katherine Wu, MD

410-502-7283kwu@jhmi.edu

Locations

Johns Hopkins Medical Institutions

Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator:

Katherine Wu, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • Ischemic cardiomyopathy
  • Nonischemic cardiomyopathy
  • Implantable cardioverter defibrillator
  • Sudden Cardiac Death
  • Ventricular tachycardia
  • Ventricular fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-01-20.