BUDAPEST-CRT升级研究是第一个前瞻性的,随机化,多中心临床试验调查心脏再同步化治疗(CRT)升级后心力衰竭(HF)患者的结果间歇性或永久性右心室(RV)起搏和宽节奏QRS。本报告描述了入选患者的基线临床特征,并将其与先前具有里程碑意义的CRT研究的队列进行了比较。
这项国际多中心随机对照试验调查了360名患者在入选前至少6个月内使用起搏器(PM)或植入式心律转复除颤器(ICD)。左心室射血分数降低(LVEF≤35%),HF症状(纽约心脏协会[NYHA]功能类II-IVa),宽节奏QRS(150ms),和≥20%的右心室起搏负担,而没有天然的左束支传导阻滞。在入学时,患者的平均年龄为73±8岁;89%为男性,97%为NYHAII/III类功能类,56%有心房颤动。注册患者主要使用常规PM设备,平均右心室起搏负担为86%。因此,这是一个患有晚期HF的患者队列,低基线LVEF(25±7%),高N末端B型利钠肽前体(NT-proBNP)水平(2231pg/ml[第25-75百分位数1254-4309pg/ml]),在过去的12个月中频繁的HF住院(50%)。
与之前的CRT试验队列相比,BUDAPEST-CRT升级研究包括男性占优势,房颤和其他合并症负担较高的老年患者.此外,该队列代表LVEF低的晚期HF人群,高NT-proBNP,和以前频繁的HF事件。
ClinicalTrials.govNCT02270840。
The BUDAPEST-CRT
Upgrade study is the first prospective, randomized, multicentre clinical
trial investigating the outcomes after cardiac resynchronization therapy (CRT)
upgrade in heart failure (HF) patients with intermittent or permanent right ventricular (RV) pacing with wide paced QRS. This report describes the baseline clinical characteristics of the enrolled patients and compares them to cohorts from previous milestone CRT studies.
This international multicentre randomized controlled
trial investigates 360 patients having a pacemaker (PM) or implantable cardioverter defibrillator (ICD) device for at least 6 months prior to enrolment, reduced left ventricular ejection fraction (LVEF ≤35%), HF symptoms (New York Heart Association [NYHA] functional class II-IVa), wide paced QRS (>150 ms), and ≥20% of RV pacing burden without having a native left bundle branch block. At enrolment, the mean age of the patients was 73 ± 8 years; 89% were male, 97% were in NYHA class II/III functional class, and 56% had atrial fibrillation. Enrolled patients predominantly had conventional PM devices, with a mean RV pacing burden of 86%. Thus, this is a patient cohort with advanced HF, low baseline LVEF (25 ± 7%), high N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (2231 pg/ml [25th-75th percentile 1254-4309 pg/ml]), and frequent HF hospitalizations during the preceding 12 months (50%).
When compared with prior CRT
trial cohorts, the BUDAPEST-CRT
Upgrade study includes older patients with a strong male predominance and a high burden of atrial fibrillation and other comorbidities. Moreover, this cohort represents an advanced HF population with low LVEF, high NT-proBNP, and frequent previous HF events.
ClinicalTrials.gov NCT02270840.