TY - JOUR
T1 - Rationale and design of the BUDAPEST-CRT Upgrade Study
T2 - A prospective, randomized, multicentre clinical trial
AU - Merkely, Bela
AU - Kosztin, Annamaria
AU - Roka, Attila
AU - Geller, Laszlo
AU - Zima, Endre
AU - Kovacs, Attila
AU - Boros, Andras Mihaly
AU - Klein, Helmut
AU - Wranicz, Jerzy K.
AU - Hindricks, Gerhard
AU - Clemens, Marcell
AU - Duray, Gabor Z.
AU - Moss, Arthur J.
AU - Goldenberg, Ilan
AU - Kutyifa, Valentina
N1 - Funding Information:
The study is supported by an unrestricted research grant from the Boston Scientific (St. Paul, MN, USA) Investigator Sponsored Research Fund to the Semmelweis University, Budapest, Hungary.
Publisher Copyright:
© 2017 The Author.
PY - 2017
Y1 - 2017
N2 - Aims There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. Methods and results The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF = 35%, NYHA functional classes II - IVa, paced QRS = 150 ms, and a RV pacing = 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. Conclusion The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing.
AB - Aims There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. Methods and results The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF = 35%, NYHA functional classes II - IVa, paced QRS = 150 ms, and a RV pacing = 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. Conclusion The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing.
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U2 - 10.1093/europace/euw193
DO - 10.1093/europace/euw193
M3 - Article
C2 - 28339581
AN - SCOPUS:85030556908
VL - 19
SP - 1549
EP - 1555
JO - Europace
JF - Europace
SN - 1099-5129
IS - 9
ER -