Circulating Biomarkers and Ventricular Tachyarrhythmia (LIFEMARKER)

This study is currently recruiting participants.
Verified July 2013 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: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition
Cardiomyopathy
Ventricular Tachycardia
Ventricular Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Circulating Biomarkers and Ventricular Tachyarrhythmia

Resource links provided by NLM:


Further study details as provided by Ochsner Health System:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood samples will be stored frozen for future analysis.


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01892462

Locations
United States, Louisiana
Ochsner Health System Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Daniel P Morin, MD, MPH, FHRS    5048425059    dmorin@ochsner.org   
Principal Investigator: Daniel P Morin, MD MPH         
Sponsors and Collaborators
Ochsner Health System
Boston Scientific Corporation
Investigators
Principal Investigator: Daniel P Morin, MD MPH Ochsner Medical Foundation
  More Information

No publications provided

Responsible Party: Dr. Daniel P Morin, MD MPH FHRS, Cardiac Electrophysiologist, Director of Cardiovascular Research, Ochsner Health System
ClinicalTrials.gov Identifier: NCT01892462     History of Changes
Other Study ID Numbers: ISRCRM400003
Study First Received: July 1, 2013
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014