Clinical trial NCT01892462: Circulating Biomarkers and Ventricular Tachyarrhythmia
Official title: Circulating Biomarkers and Ventricular Tachyarrhythmia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2013-07-04
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
Study officials:
affiliation: Ochsner Medical Foundation
name: Daniel P Morin, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morin DP, Chong-Yik R, Thihalolipavan S, Krauthammer YS, Bernard ML, Khatib S, Polin GM, Rogers PA. Utility of serial measurement of biomarkers of cardiovascular stress and inflammation in systolic dysfunction. Europace. 2020 Jul 1;22(7):1044-1053. doi: 10.1093/europace/euaa075.