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Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial
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 fail...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5834067/ https://www.ncbi.nlm.nih.gov/pubmed/28339581 http://dx.doi.org/10.1093/europace/euw193 |
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author | Merkely, Bela Kosztin, Annamaria Roka, Attila Geller, Laszlo Zima, Endre Kovacs, Attila Boros, Andras Mihaly Klein, Helmut Wranicz, Jerzy K. Hindricks, Gerhard Clemens, Marcell Duray, Gabor Z. Moss, Arthur J. Goldenberg, Ilan Kutyifa, Valentina |
author_facet | Merkely, Bela Kosztin, Annamaria Roka, Attila Geller, Laszlo Zima, Endre Kovacs, Attila Boros, Andras Mihaly Klein, Helmut Wranicz, Jerzy K. Hindricks, Gerhard Clemens, Marcell Duray, Gabor Z. Moss, Arthur J. Goldenberg, Ilan Kutyifa, Valentina |
author_sort | Merkely, Bela |
collection | PubMed |
description | 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. CLINICAL TRIALS.GOV IDENTIFIER: NCT02270840. |
format | Online Article Text |
id | pubmed-5834067 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-58340672018-03-07 Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial Merkely, Bela Kosztin, Annamaria Roka, Attila Geller, Laszlo Zima, Endre Kovacs, Attila Boros, Andras Mihaly Klein, Helmut Wranicz, Jerzy K. Hindricks, Gerhard Clemens, Marcell Duray, Gabor Z. Moss, Arthur J. Goldenberg, Ilan Kutyifa, Valentina Europace Clinical Research 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. CLINICAL TRIALS.GOV IDENTIFIER: NCT02270840. Oxford University Press 2017-09 2016-10-06 /pmc/articles/PMC5834067/ /pubmed/28339581 http://dx.doi.org/10.1093/europace/euw193 Text en © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Clinical Research Merkely, Bela Kosztin, Annamaria Roka, Attila Geller, Laszlo Zima, Endre Kovacs, Attila Boros, Andras Mihaly Klein, Helmut Wranicz, Jerzy K. Hindricks, Gerhard Clemens, Marcell Duray, Gabor Z. Moss, Arthur J. Goldenberg, Ilan Kutyifa, Valentina Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial |
title | Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial |
title_full | Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial |
title_fullStr | Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial |
title_full_unstemmed | Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial |
title_short | Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial |
title_sort | rationale and design of the budapest-crt upgrade study: a prospective, randomized, multicentre clinical trial |
topic | Clinical Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5834067/ https://www.ncbi.nlm.nih.gov/pubmed/28339581 http://dx.doi.org/10.1093/europace/euw193 |
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