Rationale and design of the BUDAPEST-CRT Upgrade Study

A prospective, randomized, multicentre clinical trial

B. Merkely, Annamaria Kosztin, Attila Roka, L. Gellér, E. Zima, Attila Kovacs, Andras Mihaly Boros, Helmut Klein, Jerzy K. Wranicz, Gerhard Hindricks, Marcell Clemens, G. Duray, Arthur J. Moss, Ilan Goldenberg, Valentina Kutyifa

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)1549-1555
Number of pages7
JournalEuropace
Volume19
Issue number9
DOIs
Publication statusPublished - Jan 1 2017

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Cardiac Resynchronization Therapy
Multicenter Studies
Stroke Volume
Randomized Controlled Trials
Prospective Studies
Heart Failure
Defibrillators
Safety
Mortality
Natriuretic Peptides
Random Allocation
Quality of Life
Research Personnel
Clinical Trials

Keywords

  • Cardiac resynchronization therapy upgrade
  • Dyssynchrony
  • Pacing-induced heart failure
  • Randomized controlled trial
  • Right ventricular pacing
  • Study design

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Rationale and design of the BUDAPEST-CRT Upgrade Study : A prospective, randomized, multicentre clinical trial. / Merkely, B.; Kosztin, Annamaria; Roka, Attila; Gellér, L.; Zima, E.; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K.; Hindricks, Gerhard; Clemens, Marcell; Duray, G.; Moss, Arthur J.; Goldenberg, Ilan; Kutyifa, Valentina.

In: Europace, Vol. 19, No. 9, 01.01.2017, p. 1549-1555.

Research output: Contribution to journalArticle

Merkely, B, Kosztin, A, Roka, A, Gellér, L, Zima, E, Kovacs, A, Boros, AM, Klein, H, Wranicz, JK, Hindricks, G, Clemens, M, Duray, G, Moss, AJ, Goldenberg, I & Kutyifa, V 2017, 'Rationale and design of the BUDAPEST-CRT Upgrade Study: A prospective, randomized, multicentre clinical trial', Europace, vol. 19, no. 9, pp. 1549-1555. https://doi.org/10.1093/europace/euw193
Merkely, B. ; Kosztin, Annamaria ; Roka, Attila ; Gellér, L. ; Zima, E. ; Kovacs, Attila ; Boros, Andras Mihaly ; Klein, Helmut ; Wranicz, Jerzy K. ; Hindricks, Gerhard ; Clemens, Marcell ; Duray, G. ; Moss, Arthur J. ; Goldenberg, Ilan ; Kutyifa, Valentina. / Rationale and design of the BUDAPEST-CRT Upgrade Study : A prospective, randomized, multicentre clinical trial. In: Europace. 2017 ; Vol. 19, No. 9. pp. 1549-1555.
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AU - Kosztin, Annamaria

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AU - Gellér, L.

AU - Zima, E.

AU - Kovacs, Attila

AU - Boros, Andras Mihaly

AU - Klein, Helmut

AU - Wranicz, Jerzy K.

AU - Hindricks, Gerhard

AU - Clemens, Marcell

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AU - Goldenberg, Ilan

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KW - Dyssynchrony

KW - Pacing-induced heart failure

KW - Randomized controlled trial

KW - Right ventricular pacing

KW - Study design

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