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

J 2022

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

TABORSKY, Milos, Tomas SKALA, Renata AIGLOVA, Marian FEDORCO, Josef KAUTZNER et. al.

Základní údaje

Originální název

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

Autoři

TABORSKY, Milos (203 Česká republika), Tomas SKALA (203 Česká republika), Renata AIGLOVA (203 Česká republika), Marian FEDORCO (203 Česká republika), Josef KAUTZNER (203 Česká republika), Tomas JANDIK (203 Česká republika), Vlastimil VANCURA (203 Česká republika), Ales LINHART, Martin VALEK (203 Česká republika), Miloslav NOVAK (203 Česká republika), Petr KALA, Rostislav POLASEK (203 Česká republika), Tomas ROUBICEK (203 Česká republika), Alexandr SCHEE, Gerhard HINDRICKS, Nikolaos DAGRES, Robert HATALAJ a Jiří JARKOVSKÝ (203 Česká republika, domácí)

Vydání

Biomedical Papers, Olomouc: Palacky University, Olomouc, Palacky University, 2022, 1213-8118

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30201 Cardiac and Cardiovascular systems

Stát vydavatele

Česká republika

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 0.900

Kód RIV

RIV/00216224:14110/22:00125206

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.5507/bp.2021.015

UT WoS

000731340300001

Klíčová slova anglicky

non-ischemic cardiomyopathy; heart failure; implantable cardioverter-defibrillator; cardiac resynchronization therapy; magnetic resonance imaging; late gadolinium enhancement; randomized controlled trial

Štítky

14119612, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 20. 7. 2022 09:03, Mgr. Tereza Miškechová

Anotace

V originále

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

Citovat

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 a 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. Biomedical Papers, Olomouc: Palacky University. Olomouc: Palacky University, 2022, roč. 166, č. 2, s. 173-179. ISSN 1213-8118. Dostupné z: https://dx.doi.org/10.5507/bp.2021.015.

@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 a 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, roč.~166, č.~2, s.~173-179. ISSN~1213-8118. Dostupné z: https://dx.doi.org/10.5507/bp.2021.015.

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