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


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.


CONCLUSIONS
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.


BACKGROUND
NCT02270840.
Heart and Vascular Center, Semmelweis University, 68 Varosmajor St, H-1122 Budapest, Hungary.
Bela
B
Merkely
Heart and Vascular Center, Semmelweis University, 68 Varosmajor St, H-1122 Budapest, Hungary.
Annamaria
A
Kosztin
Heart and Vascular Center, Semmelweis University, 68 Varosmajor St, H-1122 Budapest, Hungary.
Attila
A
Roka
Heart and Vascular Center, Semmelweis University, 68 Varosmajor St, H-1122 Budapest, Hungary.
Laszlo
L
Geller
Heart and Vascular Center, Semmelweis University, 68 Varosmajor St, H-1122 Budapest, Hungary.
Endre
E
Zima
Heart and Vascular Center, Semmelweis University, 68 Varosmajor St, H-1122 Budapest, Hungary.
Attila
A
Kovacs
Heart and Vascular Center, Semmelweis University, 68 Varosmajor St, H-1122 Budapest, Hungary.
Andras Mihaly
AM
Boros
University of Rochester Medical Center, Heart Research Program, Rochester, NY, USA.
Helmut
H
Klein
Department of Electrocardiology, Medical University of Lodz, Lodz, Poland.
Jerzy K
JK
Wranicz
Leipzig-Heart Center, University of Leipzig, Leipzig, Germany.
Gerhard
G
Hindricks
Department of Cardiology, University of Debrecen, Debrecen, Hungary.
Marcell
M
Clemens
Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
Gabor Z
GZ
Duray
University of Rochester Medical Center, Heart Research Program, Rochester, NY, USA.
Arthur J
AJ
Moss
University of Rochester Medical Center, Heart Research Program, Rochester, NY, USA.|Sheba Medical Center, Tel Hashomer, Israel.
Ilan
I
Goldenberg
Heart and Vascular Center, Semmelweis University, 68 Varosmajor St, H-1122 Budapest, Hungary.|University of Rochester Medical Center, Heart Research Program, Rochester, NY, USA.
Valentina
V
Kutyifa
D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000401:mortality; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000401:mortality; D058409:Cardiac Resynchronization Therapy Devices; D002908:Chronic Disease; D002985:Clinical Protocols; D017147:Defibrillators, Implantable; D020878:Device Removal; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005060:Europe; D017079:Exercise Tolerance; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007557:Israel; D010138:Pacemaker, Artificial; D011446:Prospective Studies; D020127:Recovery of Function; D012107:Research Design; D013318:Stroke Volume; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D000070857:Walk Test
Cardiac resynchronization therapy upgrade; Dyssynchrony; Pacing-induced heart failure; Randomized controlled trial; Right ventricular pacing; Study design