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@article{1824484, author = {Taborsky, Milos and Skala, Tomas and Aiglova, Renata and Fedorco, Marian and Kautzner, Josef and Jandik, Tomas and Vancura, Vlastimil and Linhart, Ales and Valek, Martin and Novak, Miloslav and Kala, Petr and Polasek, Rostislav and Roubicek, Tomas and Schee, Alexandr and Hindricks, Gerhard and Dagres, Nikolaos and Hatalaj, Robert and Jarkovský, Jiří}, article_location = {Olomouc}, article_number = {2}, doi = {http://dx.doi.org/10.5507/bp.2021.015}, keywords = {non-ischemic cardiomyopathy; heart failure; implantable cardioverter-defibrillator; cardiac resynchronization therapy; magnetic resonance imaging; late gadolinium enhancement; randomized controlled trial}, language = {eng}, issn = {1213-8118}, journal = {Biomedical Papers, Olomouc: Palacky University}, title = {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}, url = {https://biomed.papers.upol.cz/corproof.php?tartkey=bio-000000-2769}, volume = {166}, year = {2022} }
TY - JOUR ID - 1824484 AU - 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 PY - 2022 TI - 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 JF - Biomedical Papers, Olomouc: Palacky University VL - 166 IS - 2 SP - 173-179 EP - 173-179 PB - Palacky University SN - 12138118 KW - non-ischemic cardiomyopathy KW - heart failure KW - implantable cardioverter-defibrillator KW - cardiac resynchronization therapy KW - magnetic resonance imaging KW - late gadolinium enhancement KW - randomized controlled trial UR - https://biomed.papers.upol.cz/corproof.php?tartkey=bio-000000-2769 N2 - 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 ER -
TABORSKY, Milos, Tomas SKALA, Renata AIGLOVA, Marian FEDORCO, Josef KAUTZNER, Tomas JANDIK, Vlastimil VANCURA, Ales LINHART, Martin VALEK, Miloslav NOVAK, Petr KALA, Rostislav POLASEK, Tomas ROUBICEK, Alexandr SCHEE, Gerhard HINDRICKS, Nikolaos DAGRES, Robert HATALAJ and Jiří JARKOVSKÝ. 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. \textit{Biomedical Papers, Olomouc: Palacky University}. Olomouc: Palacky University, 2022, vol.~166, No~2, p.~173-179. ISSN~1213-8118. Available from: https://dx.doi.org/10.5507/bp.2021.015.
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