Diagnostic Investigation of Sudden Cardiac Event Risk

Heart Failure Clinical Trial

— DISCERN  

Official title:

Identifying Markers That Predict Ventricular Arrhythmia Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500708
• Other study ID #: CDX_000003
• Secondary ID: DISCERN
• Status: Completed
• Phase: N/A
• First received: July 11, 2007
• Last updated: October 17, 2017
• Start date: July 2007
• Est. completion date: August 1, 2011

Study information

• Verified date: October 2017
• Source: CardioDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1564
• Est. completion date: August 1, 2011
• Est. primary completion date: August 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Implantable cardiac defibrilIator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) implanted for primary prevention

• Left ventricular ejection fraction (LVEF) = 50 %

• Ability to collect clinical follow-up and endpoint information, including device interrogation data

Exclusion Criteria:

• Congenital heart disease

• Known inherited arrhythmia disorder

• Organ transplantation

• Inability to give informed consent

Related Conditions & MeSH terms

• Arrhythmia
• Cardiovascular Diseases
• CVD
• Heart Failure

Locations

Country	Name	City	State
United States	Alaska Heart Institute	Anchorage	Alaska
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Minneapolis Heart Institute and Foundation	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Palo Alto Medical Foundation	Palo Alto	California
United States	West Penn Allegheny Health System	Pittsburgh	Pennsylvania
United States	Intermountain Healthcare	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
CardioDx

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Ab

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene discovery	Genome Wide Association Study (GWAS)	up to 3 years