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Observational Study on Heart Structure and Sudden Cardiac Death

This study is looking at how the structure of your heart's left ventricle (the main pumping chamber) might predict your risk of sudden cardiac death (SCD). Doctors currently use a measure called LVEF (left ventricular ejection fraction, which shows how well your heart pumps) to decide if you need an ICD (implantable cardioverter defibrillator, a device that can prevent SCD). However, this study aims to find better ways to identify who truly benefits from an ICD. You may be able to join if you are between 21 and 80 years old, have an LVEF of 35% or less, and are being considered for an ICD for the first time. The study will track your health every six months for five years to see if certain heart structural issues are linked to SCD.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to include 400 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed every 6 months for 5 years to track SCD outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01076660

Left Ventricular Structural Predictors of Sudden Cardiac Death

Recruiting
Not specifiedAges 21–80Observational
Johns Hopkins University
~400 participants
Updated 2026-01-20 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite SCD outcomes
Measured over Every 6 months for 5 years

Conditions

Ischemic Cardiomyopathy
Nonischemic Cardiomyopathy

Explore related trials

Generalized ischemic myocardial dysfunction

Where it's being run

2 sites across 2 states
Delaware1
Maryland1

Study leadership

  • Katherine Wu, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Katherine Wu, MD
[email protected]
410-502-7283
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Composite SCD outcomesEvery 6 months for 5 years

    The first occurrence of an adjudicated appropriate ICD firing for ventricular tachycardia/ventricular fibrillation or cardiac death not treated by the ICD.