PMID- 33724264
OWN - NLM
STAT- MEDLINE
DCOM- 20220519
LR  - 20220519
IS  - 1804-7521 (Electronic)
IS  - 1213-8118 (Linking)
VI  - 166
IP  - 2
DP  - 2022 May
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.
PG  - 173-179
LID - 10.5507/bp.2021.015 [doi]
AB  - 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 advances 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. CLINICALTRIALS: gov, NCT04139460.
FAU - Taborsky, Milos
AU  - Taborsky M
AD  - Department of Internal Medicine I - Cardiology, University Hospital Olomouc and 
      Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.
FAU - Skala, Tomas
AU  - Skala T
AD  - Department of Internal Medicine I - Cardiology, University Hospital Olomouc and 
      Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.
FAU - Aiglova, Renata
AU  - Aiglova R
AD  - Department of Internal Medicine I - Cardiology, University Hospital Olomouc and 
      Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.
FAU - Fedorco, Marian
AU  - Fedorco M
AD  - Department of Internal Medicine I - Cardiology, University Hospital Olomouc and 
      Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.
FAU - Kautzner, Josef
AU  - Kautzner J
AD  - Cardiology Department, Institute for Clinical and Experimental Medicine, Prague, 
      Czech Republic.
FAU - Jandik, Tomas
AU  - Jandik T
AD  - Department of Cardiology, University Hospital Pilzen, Czech Republic.
FAU - Vancura, Vlastimil
AU  - Vancura V
AD  - Department of Cardiology, University Hospital Pilzen, Czech Republic.
FAU - Linhart, Ales
AU  - Linhart A
AD  - The Internal Clinic of Cardiology and Angiology of the First Faculty of Medicine 
      and General Teaching Hospital, Czech Republic.
FAU - Valek, Martin
AU  - Valek M
AD  - The Internal Clinic of Cardiology and Angiology of the First Faculty of Medicine 
      and General Teaching Hospital, Czech Republic.
FAU - Novak, Miloslav
AU  - Novak M
AD  - St. Anne's University Hospital Brno, Czech Republic.
FAU - Kala, Petr
AU  - Kala P
AD  - University Hospital Brno, Czech Republic.
FAU - Polasek, Rostislav
AU  - Polasek R
AD  - Liberec Hospital, Czech Republic.
FAU - Roubicek, Tomas
AU  - Roubicek T
AD  - Liberec Hospital, Czech Republic.
FAU - Schee, Alexandr
AU  - Schee A
AD  - Private Cardiovascular Center Karlovy Vary Kardio KV L.T.D., Czech Republic.
FAU - Hindricks, Gerhard
AU  - Hindricks G
AD  - Herzzentrum Leipzig, Germany.
FAU - Dagres, Nikolaos
AU  - Dagres N
AD  - Herzzentrum Leipzig, Germany.
FAU - Hatala, Robert
AU  - Hatala R
AD  - Cardiological Clinic of National Institute of CV Diseases in Bratislava, Slovak 
      Republic.
FAU - Jarkovsky, Jiri
AU  - Jarkovsky J
AD  - Institute for Biostatistics and Analyses of Faculty of Medicine Brno, Czech 
      Republic.
LA  - eng
SI  - ClinicalTrials.gov/NCT04139460
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210312
PL  - Czech Republic
TA  - Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub
JT  - Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, 
      Czechoslovakia
JID - 101140142
RN  - 0 (Contrast Media)
RN  - AU0V1LM3JT (Gadolinium)
SB  - IM
MH  - *Cardiac Resynchronization Therapy
MH  - *Cardiomyopathies/therapy
MH  - *Cardiomyopathy, Dilated/complications/diagnostic imaging/therapy
MH  - Contrast Media
MH  - *Defibrillators, Implantable
MH  - Fibrosis
MH  - Gadolinium
MH  - *Heart Failure
MH  - Humans
MH  - Magnetic Resonance Imaging
MH  - Prospective Studies
MH  - Quality of Life
MH  - *Tachycardia, Ventricular/therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - cardiac resynchronization therapy
OT  - heart failure
OT  - implantable cardioverter-defibrillator
OT  - late gadolinium enhancement
OT  - magnetic resonance imaging
OT  - non-ischemic cardiomyopathy
OT  - randomized controlled trial
COIS- The authors report no conflicts of interest in this work.
EDAT- 2021/03/17 06:00
MHDA- 2022/05/20 06:00
CRDT- 2021/03/16 12:31
PHST- 2020/12/15 00:00 [received]
PHST- 2021/02/05 00:00 [accepted]
PHST- 2021/03/17 06:00 [pubmed]
PHST- 2022/05/20 06:00 [medline]
PHST- 2021/03/16 12:31 [entrez]
AID - 10.5507/bp.2021.015 [doi]
PST - ppublish
SO  - Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 May;166(2):173-179. 
      doi: 10.5507/bp.2021.015. Epub 2021 Mar 12.