Prospective Study to Identify Patients at Risk of Dangerous Ventricular Arrhythmias (HIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00562757
Recruitment Status : Unknown
Verified November 2007 by Harbinger Medical, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 22, 2007
Last Update Posted : November 22, 2007
Information provided by:
Harbinger Medical, Inc.

Brief Summary:
The purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.

Condition or disease
Sudden Cardiac Death

Detailed Description:

Sudden cardiac death (SCD) accounts for half of all deaths from cardiovascular causes, with an annual incidence of 1 to 2 deaths per 1000 population. In the United States this translates to between 300,000 to more than 400,000 deaths annually. Results from numerous large, well designed clinical trials have demonstrated the efficacy of the implantable cardioverter-defibrillator (ICD) for improving survival in patients with ischemic heart disease. However, measures used to risk stratify patients, such as left ventricular ejection fraction do not adequately identify those patients who can most benefit from ICD therapy. As a result, many patients who currently receive an ICD do not use the device. In addition, many more patients who could benefit from ICD therapy are outside of current guidelines and do not have access to this life-saving therapy.

This prospective study was intended to determine how well the Harbinger Wedensky Modulation Index (WMI) technique risk stratifies patients into two groups: those needing antiarrhythmic therapy and those who do not need antiarrhythmic therapy.

Study Type : Observational
Actual Enrollment : 320 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Harbinger ICD Patient (HIP) Study
Study Start Date : September 2003
Estimated Study Completion Date : October 2009

Post myocardial infarction patients who received an ICD, stratified into low versus high WMI groups

Primary Outcome Measures :
  1. Life Threatening Cardiac Event (death or annotated malignant ventricular arrhythmia detected by ICD and confirmed by cardiologist review) [ Time Frame: Up to two years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Post myocardial infarction patients who received an ICD are included. Enrollment is at eight sites - four in the USA and four in three European countries. The enrollment sites are hospitals and teaching institutions.

Inclusion Criteria:

  • Post myocardial infarction patients receiving ICD therapy

Exclusion Criteria:

  • Patients unable to give consent
  • Pacemaker dependant patients
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00562757

United States, Arizona
Arizona Arrhythmia Consultants
Phoenix, Arizona, United States, 85251
United States, Kansas
Galichia Heart Hospital
Wichita, Kansas, United States, 67220
United States, Massachusetts
Caritas St. Elizabeth's Hospital
Boston, Massachusetts, United States, 02135
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
University of Bonn
Bonn, Germany, D-53105
University of Mannheim
Mannheim, Germany, 68167
Oslo, Norway, 0027
Kantonsspital Luzern
Luzern, Switzerland, CH-6000
Sponsors and Collaborators
Harbinger Medical, Inc.
Study Director: Harold Hoium, MBA Harbinger Medical, Inc. Identifier: NCT00562757     History of Changes
Other Study ID Numbers: HMI-HIP
First Posted: November 22, 2007    Key Record Dates
Last Update Posted: November 22, 2007
Last Verified: November 2007

Keywords provided by Harbinger Medical, Inc.:
Wedensky modulation
Risk stratification
Ischemic heart disease
ICD guidelines
Myocardial infarction

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden