Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

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.

CLINICAL TRIALS.GOV IDENTIFIER:

NCT02270840.

• Authors: Bela Merkely, Annamaria Kosztin, Attila Roka, Laszlo Geller, Endre Zima, Attila Kovacs, Andras Mihaly Boros, Helmut Klein, Jerzy K Wranicz, Gerhard Hindricks, Marcell Clemens, Gabor Z Duray, Arthur J Moss, Ilan Goldenberg, Valentina Kutyifa
• Journal: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology (Europace) Vol. 19 Issue 9 Pg. 1549-1555 (Sep 01 2017) ISSN: 1532-2092 [Electronic] England
• PMID: 28339581 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

Topics

• Cardiac Pacing, Artificial (adverse effects, mortality)
• Cardiac Resynchronization Therapy (adverse effects, mortality)
• Cardiac Resynchronization Therapy Devices
• Chronic Disease
• Clinical Protocols
• Defibrillators, Implantable
• Device Removal
• Electric Countershock (adverse effects, instrumentation, mortality)
• Europe
• Exercise Tolerance
• Heart Failure (diagnosis, mortality, physiopathology, therapy)
• Humans
• Israel
• Pacemaker, Artificial
• Prospective Studies
• Recovery of Function
• Research Design
• Stroke Volume
• Time Factors
• Treatment Outcome
• Ventricular Function, Left
• Walk Test