Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1564 participants
OBSERVATIONAL
2007-07-31
2011-08-01
Brief Summary
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Detailed Description
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Phase I: Discovery - genes/biomarkers/clinical factors Phase II: Algorithm Development Phase III: Assay Validation
The final algorithm (Assay) may incorporate a combination of factors including genetic markers, biomarker(s), and clinical factor(s). Participation in the study does not alter clinical care. The procedures required by the protocol are collection of a research blood sample (at baseline only) and interviews with the subject to collect specific clinical information at baseline and follow-up (6 mos, 1 yr, 2 yr, 3 yr, 4 yr, and 5 yr) after enrollment. All other data collected is in accordance with the participating institution's standard patient care.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction (LVEF) ≤ 50 %
* Ability to collect clinical follow-up and endpoint information, including device interrogation data
Exclusion Criteria
* Known inherited arrhythmia disorder
* Organ transplantation
* Inability to give informed consent
18 Years
90 Years
ALL
No
Sponsors
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CardioDx
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Zapien, MS
Role: STUDY_DIRECTOR
CardioDx, Inc.
Locations
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Alaska Heart Institute
Anchorage, Alaska, United States
Palo Alto Medical Foundation
Palo Alto, California, United States
Minneapolis Heart Institute and Foundation
Minneapolis, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
West Penn Allegheny Health System
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Countries
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References
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Hranitzky PM, Sehnert AJ, Blanchard JL, et al. Abstract 16410: Identification of novel genetic markers associated with lethal ventricular arrhythmias in heart failure patients: genome wide association study in the DISCERN cohort. Circulation. 2010;122. Abstract 16410.
Other Identifiers
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DISCERN
Identifier Type: OTHER
Identifier Source: secondary_id
CDX_000003
Identifier Type: -
Identifier Source: org_study_id