Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in patients with dilated cardiomyopathy and heart failure without late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMRI) high-risk markers- CRT-REALITY study - Study design and rationale

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TABORSKY Milos SKALA Tomas AIGLOVA Renata FEDORCO Marian KAUTZNER Josef JANDIK Tomas VANCURA Vlastimil LINHART Ales VALEK Martin NOVAK Miloslav KALA Petr POLASEK Rostislav ROUBICEK Tomas SCHEE Alexandr HINDRICKS Gerhard DAGRES Nikolaos HATALAJ Robert JARKOVSKÝ Jiří

Rok publikování 2022
Druh Článek v odborném periodiku
Časopis / Zdroj Biomedical Papers, Olomouc: Palacky University
Fakulta / Pracoviště MU

Lékařská fakulta

Citace
www https://biomed.papers.upol.cz/corproof.php?tartkey=bio-000000-2769
Doi http://dx.doi.org/10.5507/bp.2021.015
Klíčová slova non-ischemic cardiomyopathy; heart failure; implantable cardioverter-defibrillator; cardiac resynchronization therapy; magnetic resonance imaging; late gadolinium enhancement; randomized controlled trial
Popis Background. Primary preventive implantation of implantable defibrillator (ICD) is according to current guidelines indicated in patients with heart failure NYHA (New York Heart Association) class II/III and LVEF <35%. Thanks to ad-vances in heart failure pharmacotherapy, a decrease in mortality could render a benefit of ICD insufficient to justify its implantation in some patients. Methods. Study design: multicenter, prospective, randomized, controlled trial evaluating the benefit of implantation of Cardiac Resynchronization and Defibrillator Therapy (CRT-D) or CRT Alone (CRT-P) in non-ischemic patients with reduced left ventricle ejection fraction (LVEF) and optimal pharmacotherapy without significant mid-wall myocardial fibrosis detected by cardiac magnetic resonance (CMR). The primary end-point: Re-hospitalization for heart failure, ventricular tachycardia, major adverse cardiac events (MACE). The secondary end-points: Sudden cardiac death, cardiovascular death, resuscitated cardiac arrest or sustained ventricular tachycardia, device-related complications, and change in quality of life. Course of the study: After a pharmacotherapy is optimized and significant mid-wall myocardial fibrosis excluded, patients will be randomized 1:1 to CRT-P or CRT-D implantation. Discussion. If our hypothesis is confirmed, this could provide evidence for the management of these patients with a significant impact on common daily praxis and health care expenditures. Trial registration. ClinicalTrials.gov, NCT04139460

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