Identifying heart structure predictors of sudden cardiac death
Official title: Left Ventricular Structural Predictors of Sudden Cardiac Death [Substudy of: Functional Energetics and Imaging for Phenotypic Characterization of Patients at Risk for Sudden Cardiac Death, See Also NCT000181233]
Run by Johns Hopkins University · NCT01076660 · Data updated 2026-11-12
This study is trying to see if certain heart structure problems can help predict the risk of sudden cardiac death in patients with weak heart function who may need a defibrillator.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 21 Years to 80 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Newark, Delaware and 1 other locations) |
| Status | Recruiting |
| Started | October 2003 |
| Main results expected | June 2028 |
| Study ends | June 2030 |
| Registry record updated | January 20, 2026 |
| Trial ID | NCT01076660 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 to 80 with a left ventricular ejection fraction of 35% or less, referred for ICD insertion for primary prevention.
✕Probably not a fit
Patients who have contraindications to MRI, such as implanted metallic devices or severe heart failure, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the relationship between left ventricular structural abnormalities and the risk of sudden cardiac death (SCD) in patients with low heart function. It aims to improve risk stratification for patients eligible for implantable cardioverter defibrillators (ICDs) by examining detailed cardiac magnetic resonance imaging data. The study focuses on patients with a left ventricular ejection fraction (LVEF) of 35% or less, who are referred for ICD insertion without a history of sustained ventricular arrhythmias. By identifying additional structural predictors, the study seeks to enhance the selection criteria for ICD therapy beyond current guidelines.
Why it matters
Potential benefit: If successful, this study could lead to better identification of patients at risk for sudden cardiac death, potentially improving treatment outcomes and reducing unnecessary complications from ICDs.
How similar studies have gone: While there have been limited cohort studies on this topic, this study represents a novel prospective approach to understanding SCD risk in a larger patient population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States Recruiting -
Christiana Care Health Services
Newark, Delaware, United States Active not recruiting
Study contacts
- Principal investigator: Katherine Wu, MD — Johns Hopkins University
- Study coordinator: Katherine Wu, MD
- Email: kwu@jhmi.edu
- Phone: 410-502-7283
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.