Circulating Biomarkers and Ventricular Tachyarrhythmia (LIFEMARKER)
Verified October 2014 by Ochsner Health System
Boston Scientific Corporation
Information provided by (Responsible Party):
Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System
First received: July 1, 2013
Last updated: October 16, 2014
Last verified: October 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Circulating Biomarkers and Ventricular Tachyarrhythmia
Biospecimen Retention: Samples With DNA
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 ]
Blood samples will be stored frozen for future analysis.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- left ventricular ejection fraction [LVEF] <=35%
- ICD implant
- Recent myocardial infarction (12 weeks)
- Recent revascularization (12 weeks)
- Recent hospitalization for any cause (6 weeks)
- History of rheumatologic disease
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01892462
|Ochsner Health System
|New Orleans, Louisiana, United States, 70121 |
|Contact: Daniel P Morin, MD, MPH, FHRS 5048425059 firstname.lastname@example.org |
|Principal Investigator: Daniel P Morin, MD MPH |
Ochsner Health System
Boston Scientific Corporation
||Daniel P Morin, MD MPH
||Ochsner Medical Foundation
No publications provided
||Dr. Daniel P Morin, MD MPH FHRS, Cardiac Electrophysiologist, Director of Cardiovascular Research, Ochsner Health System
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 1, 2013
||October 16, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015