Circulating Biomarkers and Ventricular Tachyarrhythmia

NCT01892462 | Completed DMC

• 1 other identifier: ISRCRM400003
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy; Ventricular Tachycardia; Ventricular Fibrillation

Outcome Measures

Primary Outcomes (1)

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

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Recent myocardial infarction (12 weeks)
• Recent revascularization (12 weeks)
• Recent hospitalization for any cause (6 weeks)
• History of rheumatologic disease

Sponsors & Collaborators

• Ochsner Health System: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Related Publications (1)

• 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.

  PMID: 32357207 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be stored frozen for future analysis.

MeSH Terms

Conditions

Cardiomyopathies; Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel P Morin, MD MPH

  Ochsner Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Electrophysiologist, Director of Cardiovascular Research

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 4, 2013
• Study Start: June 1, 2012
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 7, 2017

Record last verified: 2017-04

Locations

US (1)