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.
Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub
; 166(2): 173-179, 2022 May.
Article
in En
| MEDLINE
| ID: mdl-33724264
ABSTRACT
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:
Studydesign:
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 11 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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Cardiomyopathy, Dilated
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Tachycardia, Ventricular
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Defibrillators, Implantable
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Cardiac Resynchronization Therapy
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Heart Failure
/
Cardiomyopathies
Type of study:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Observational_studies
/
Qualitative_research
Aspects:
Patient_preference
Limits:
Humans
Language:
En
Journal:
Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub
Journal subject:
MEDICINA
Year:
2022
Document type:
Article
Affiliation country:
Czech Republic