AnaLysIs of Both sex and device specific factoRs on outcomes in pAtients with non-ischemic cardiomyopathy (BIO-LIBRA): Design and clinical protocol
| Autor: | Valentina Kutyifa, Scott McNitt, Karlene Cox, Spencer Rosero, Marye J. Gleva, Christopher A. Beck, Jeanne E. Poole, Mary W. Brown, Crystal Miller, Wojciech Zareba |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Cardiac resynchronization therapy Left ventricular dysfunction Ejection fraction business.industry medicine.medical_treatment Cardiomyopathy Ventricular tachycardia medicine.disease Implantable cardioverter-defibrillator Sudden cardiac death Design Paper RC666-701 Internal medicine Cohort Ventricular fibrillation Sex differences medicine Cardiology Diseases of the circulatory (Cardiovascular) system business Ventricular tachyarrhythmias |
| Zdroj: | Heart Rhythm O2 Heart Rhythm O2, Vol 1, Iss 5, Pp 376-384 (2020) |
| ISSN: | 2666-5018 |
| Popis: | Background Outcomes of patients with nonischemic cardiomyopathy and low ejection fraction implanted with an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy with a defibrillator (CRT-D), especially in contemporary, real-life cohorts, are not fully understood. Objective We aimed to better characterize outcomes of death and ventricular tachyarrhythmias in patients with nonischemic cardiomyopathy, implanted with an ICD or CRT-D, and specifically assess differences by sex. Methods The AnaLysIs of Both Sex and Device Specific FactoRs on Outcomes in PAtients with Non-Ischemic Cardiomyopathy (BIO-LIBRA) study was designed to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality events in nonischemic cardiomyopathy patients, indicated for an ICD or CRT-D implantation for the primary prevention of sudden cardiac death (SCD), with a specific focus on sex differences. We will enroll a total of 1000 subjects across 50 U.S. sites and follow patients for up to 3 years. Results The primary objective of BIO-LIBRA is to evaluate the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events by subject sex and by implanted device type. We will also assess all-cause mortality, VT or VF alone, cardiac death, and SCD in the total cohort, as well as by subject sex and by the implanted device type. In addition, the previously validated Seattle Proportional Risk Model (SPRM) will be used to compare the SPRM predicted incidence of SCD to the observed incidence. Conclusions The BIO-LIBRA study will provide novel and contemporary information regarding outcomes in patients with a NICM who receive a defibrillator. |
| Databáze: | OpenAIRE |
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