Circulating Biomarkers and Ventricular Tachyarrhythmia (LIFEMARKER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ochsner Health System
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System
ClinicalTrials.gov Identifier:
NCT01892462
First received: July 1, 2013
Last updated: October 16, 2014
Last verified: October 2014

July 1, 2013
October 16, 2014
June 2012
May 2015   (final data collection date for primary outcome measure)
to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01892462 on ClinicalTrials.gov Archive Site
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Circulating Biomarkers and Ventricular Tachyarrhythmia
Circulating Biomarkers and Ventricular Tachyarrhythmia

The purpose of this study is to determine whether levels of inflammatory markers in circulating blood can correlate with risk for dangerous heart rhythms. Patients with systolic heart failure, which has been shown to increase risk for dangerous heart rhythms, will be enrolled. All subjects will have an implantable cardioverter-defibrillator (ICD) in place, which allows regular evaluation of heart rhythm.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Blood samples will be stored frozen for future analysis.

Non-Probability Sample

Patients with cardiomyopathy (left ventricular ejection fraction [LVEF] <=35%) who are followed at our institution's ICD device clinic will have levels of circulating biomarkers (hs-CRP, IL-6, TNF-alpha, IL-1, sST2, MMP-1, CICP, CITP) and BNP assessed at three-month intervals for at least one year. Patients will be excluded from the study if they have had a recent myocardial infarction or PCI (within three months), or recent hospitalization.

Patients with obvious primary inflammatory conditions (such as lupus and rheumatoid arthritis) will be excluded. Additionally, significant events (e.g., HF hospitalizations, revascularization, medication changes, and death) will be tracked at each follow up visit for further statistical analysis.

  • Cardiomyopathy
  • Ventricular Tachycardia
  • Ventricular Fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • left ventricular ejection fraction [LVEF] <=35%
  • ICD implant

Exclusion Criteria:

  • Recent myocardial infarction (12 weeks)
  • Recent revascularization (12 weeks)
  • Recent hospitalization for any cause (6 weeks)
  • History of rheumatologic disease
Both
18 Years and older
No
United States
 
NCT01892462
ISRCRM400003
Yes
Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System
Ochsner Health System
Boston Scientific Corporation
Principal Investigator: Daniel P Morin, MD MPH Ochsner Medical Foundation
Ochsner Health System
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP