Heart Failure Clinical Trial
Official title:
Identifying Markers That Predict Ventricular Arrhythmia Risk
The overall objective of the DISCERN study is to develop and validate a genomic diagnostic assay to identify patients at increased risk for lethal ventricular arrhythmias and sudden cardiac death (SCD).
This is a prospective, multi-center, observational study. The research will be performed in
three phases, each using distinct patient cohorts:
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.
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