Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT00733590

Conditions

Heart Failure, Congestive

Death, Sudden, Cardiac

Arrhythmia

Cardiomyopathies

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to :

1. to gain a better understanding of the biological mechanisms that predispose to SCD
2. to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly

Conditions

Heart Failure, Congestive

Death, Sudden, Cardiac

Arrhythmia

Cardiomyopathies

Study ID

NCT00733590

Start date

Jun, 2003

Status verified date

Jan, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • History of acute MI at least 4 weeks old
  • Non-ischemic LV dysfunction for at least 9 months
  • Who have an ejection fraction (EF) < or = to 35%
  • Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment.
  • Who have primary prevention implants.

Exclusion Criteria:

  • ICD generator replacement for secondary prevention
  • Inability or unwillingness to provide valid informed consent
  • New York Heart Association Class IV heart failure
  • Patients with pre-existing Class 1 indications for pacemaker therapy.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Arrhythmic Sudden Death defined as a therapy from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Katherine Wu, MD

410-502-7283kwu@jhmi.edu

Locations

Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Zayd Eldadah, MD, PhD

202-877-7865Zayd.Eldadah@Medstar.Net

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Stephen R Shorofsky, MD, PhD

800-492-5538Sshorofs@medicine.umaryland.edu

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Katherine Wu, MD

410-502-7283kwu@jhmi.edu

Virginia Commonwealth University School of Medicine

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Kenneth Ellenbogen, MD

804-828-7576kellenbogen@pol.net

More Information

Sponsor

Johns Hopkins University

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Keywords

  • defibrillator, implanted
  • genomics
  • electrocardiography
  • electrophysiological study
  • proteomics

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.