The TRUST CRT trial is designed to evaluate triple-site versus standard cardiac resynchronization therapy in 100 patients with heart failure; results are not reported in this design paper.
RCT (n=100)
Single-blind
1:1
No
Does triple-site CRT-D improve clinical and functional outcomes compared to standard CRT-D in patients with moderate to severe heart failure and mechanical dyssynchrony?
The TRUST CRT trial is designed to evaluate whether triple-site pacing offers superior clinical and functional benefits over standard cardiac resynchronization therapy in patients with moderate to severe heart failure.
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 =120 ms, sinus rhythm, LV dysfunction (EF 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 et al. (2009) conducted an RCT in Heart failure (n=100). Triple-site CRT-D vs. Standard CRT-D was evaluated on 6-month 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. The TRUST CRT trial is designed to evaluate triple-site versus standard cardiac resynchronization therapy in 100 patients with heart failure; results are not reported in this design paper.