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OpenTrials
Completed

NCT Number: NCT01892462

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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Key information

Conditions

Cardiomyopathy Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiomyopathies Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Fibrillation Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

About this study

If you agree to be in this study, you will be asked to the following things:

  • you will come into the EP device clinic every three months for one year to have your device interrogated and will complete an EKG
  • you will have labs drawn to measure levels of certain markers of inflammation in the body. This information will be used to identify new ways to test for risk of abnormal heart rhythms and other heart disease
  • you will review your medications with the study coordinator and along with any recent illnesses or hospitalizations

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias.

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: LIFEMARKER

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 4, 2013
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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