title: Triple-site versus standard cardiac resynchronization therapy study (TRUST CRT): clinical rationale, design, and implementation.
abstract: 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.
authors.affiliation: First Department of Cardiology, Silesian Medical School, Silesian Center for Heart Disease, ul. Szpitalna 2, Zabrze, Poland. elfizab@poczta.onet.pl
authors.forename: Radosław
authors.initials: R
authors.lastname: Lenarczyk
authors.forename: Oskar
authors.initials: O
authors.lastname: Kowalski
authors.forename: Beata
authors.initials: B
authors.lastname: Sredniawa
authors.forename: Patrycja
authors.initials: P
authors.lastname: Pruszkowska-Skrzep
authors.forename: Sławomir
authors.initials: S
authors.lastname: Pluta
authors.forename: Adam
authors.initials: A
authors.lastname: Sokal
authors.forename: Tomasz
authors.initials: T
authors.lastname: Kukulski
authors.forename: Joanna
authors.initials: J
authors.lastname: Stabryła-Deska
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Woźniak
authors.forename: Jacek
authors.initials: J
authors.lastname: Kowalczyk
authors.forename: Teresa
authors.initials: T
authors.lastname: Zielińska
authors.forename: Michał
authors.initials: M
authors.lastname: Mazurek
authors.forename: Witold
authors.initials: W
authors.lastname: Streb
authors.forename: Marian
authors.initials: M
authors.lastname: Zembala
authors.forename: Zbigniew
authors.initials: Z
authors.lastname: Kalarus
mesh_terms: 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*