Triple-Site Versus Standard Cardiac Resynchronization Therapy Study (TRUST CRT): Clinical Rationale, Design, and Implementation

• Published in: Journal of cardiovascular electrophysiology 2009-06, Vol.20 (6), p.658-662
• Main Authors: LENARCZYK, RADOSŁAW, KOWALSKI, OSKAR, SREDNIAWA, BEATA, PRUSZKOWSKA-SKRZEP, PATRYCJA, PLUTA, SŁAWOMIR, SOKAL, ADAM, KUKULSKI, TOMASZ, STABRYŁA-DESKA, JOANNA, WOŹNIAK, ALEKSANDRA, KOWALCZYK, JACEK, ZIELIŃSKA, TERESA, MAZUREK, MICHAŁ, STREB, WITOLD, ZEMBALA, MARIAN, KALARUS, ZBIGNIEW
• Format: Article
• Language: English
• Subjects: Cardiac Pacing, Artificial - methods; clinical trial; design; heart failure; Heart Failure - complications; Heart Failure - prevention & control; Humans; multisite pacing; Research Design; response-rate; resynchronization therapy; Treatment Outcome; Ventricular Dysfunction, Left - etiology; Ventricular Dysfunction, Left - prevention & control
• ISSN: 1045-3873; 1540-8167
• DOI: 10.1111/j.1540-8167.2008.01394.x

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 (≤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 ≥120 ms, sinus rhythm, LV dysfunction (EF ≤ 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 ≥10% increase in LV ejection fraction, ≥10% in peak oxygen consumption, and ≥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.