Triple-site versus standard cardiac resynchronization therapy study (TRUST CRT): clinical rationale, design, and implementation.

摘要

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.