Triple-site versus standard cardiac resynchronization therapy study (TRUST CRT): clinical rationale, design, and implementation.
BACKGROUND
Cardiac resynchronization therapy (CRT) reduces morbidity and mortality in patients with heart failure (HF), lowered LV ejection fraction, and wide QRS. However, many patients (< or =40%) do not respond to this form of pacing. TRUST CRT is a prospective, single-center, randomized, single-blind, parallel, and controlled study that has been designed to treat patients with moderate to severe HF (NYHA III-IV), QRS > or =120 ms, sinus rhythm, LV dysfunction (EF < or = 35%), and signs of mechanical dyssynchrony.


OBJECTIVE
The primary objective will evaluate the 6-month's combined endpoint of alive status, freedom from hospitalization for HF or heart transplantation, relative > or =10% increase in LV ejection fraction, > or =10% in peak oxygen consumption, and > or =10% in 6-minute walking distance.


METHODS
Patients with HF receiving optimal pharmacotherapy, with LV dysfunction, mechanical dyssynchrony, wide QRS and sinus rhythm will be randomized in a 1: 1 fashion to standard or triple-site CRT-D. Patients will be followed for 1 week, 1, 3, and 6 months during a blind phase, then every 6 months until study completion. One hundred patients will be enrolled by the study center.


CONCLUSIONS
TRUST CRT is a randomized, clinical trial in CRT candidates to evaluate the effectiveness of triple-site pacing versus standard resynchronization in patients with HF.
Lenarczyk
Radosław
R
First Department of Cardiology, Silesian Medical School, Silesian Center for Heart Disease, ul. Szpitalna 2, Zabrze, Poland. elfizab@poczta.onet.pl
Kowalski
Oskar
O
Sredniawa
Beata
B
Pruszkowska-Skrzep
Patrycja
P
Pluta
Sławomir
S
Sokal
Adam
A
Kukulski
Tomasz
T
Stabryła-Deska
Joanna
J
Woźniak
Aleksandra
A
Kowalczyk
Jacek
J
Zielińska
Teresa
T
Mazurek
Michał
M
Streb
Witold
W
Zembala
Marian
M
Kalarus
Zbigniew
Z
D002304:Cardiac Pacing, Artificial / Q000379:methods*; D006333:Heart Failure / Q000150:complications* / Q000517:prevention & control*; D006801:Humans; D012107:Research Design; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000209:etiology* / Q000517:prevention & control*