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
First Department of Cardiology, Silesian Medical School, Silesian Center for Heart Disease, ul. Szpitalna 2, Zabrze, Poland.
J Cardiovasc Electrophysiol. 2009 Jun;20(6):658-62. doi: 10.1111/j.1540-8167.2008.01394.x.
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.
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.
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.
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.
心脏再同步治疗（CRT）可降低心力衰竭（HF）、左心室射血分数降低及QRS波增宽患者的发病率和死亡率。然而，许多患者（≤40%）对这种起搏方式无反应。TRUST CRT是一项前瞻性、单中心、随机、单盲、平行对照研究，旨在治疗中重度HF（纽约心脏协会III-IV级）、QRS波≥120毫秒、窦性心律、左心室功能障碍（射血分数≤35%）及存在机械性不同步迹象的患者。
主要目的将评估6个月时存活状态、无需因HF住院或进行心脏移植、左心室射血分数相对增加≥10%、峰值耗氧量增加≥10%及6分钟步行距离增加≥10%的联合终点。
接受最佳药物治疗、存在左心室功能障碍、机械性不同步、QRS波增宽及窦性心律的HF患者将以1:1的比例随机分为标准CRT-D组或三腔CRT-D组。在盲法阶段，患者将接受为期1周、1个月、3个月和6个月的随访，之后每6个月随访一次直至研究结束。研究中心将招募100名患者。
TRUST CRT是一项针对CRT候选患者的随机临床试验，旨在评估三腔起搏与标准再同步治疗对HF患者的有效性。
