Semmelweis University, Heart and Vascular Center, Budapest, Hungary.
Gottsegen National Cardiovascular Center, Budapest, Hungary.
Eur J Heart Fail. 2022 Sep;24(9):1652-1661. doi: 10.1002/ejhf.2609. Epub 2022 Jul 22.
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.
BUDAPEST-CRT 升级研究是首个前瞻性、随机、多中心临床试验，旨在研究伴有间歇性或永久性右心室（RV）起搏且 QRS 波宽大（>150ms）的心力衰竭（HF）患者行心脏再同步治疗（CRT）升级后的结局。该研究报告描述了纳入患者的基线临床特征，并与之前里程碑式 CRT 研究的队列进行了比较。
这项国际多中心随机对照试验纳入了 360 例至少在入组前 6 个月内植入起搏器（PM）或植入式心律转复除颤器（ICD）的患者，这些患者左心室射血分数（LVEF≤35%）降低，HF 症状（纽约心脏协会[NYHA]功能分级 II-IVa），QRS 波宽大（>150ms），RV 起搏比例≥20%，但无固有左束支传导阻滞。入组时，患者的平均年龄为 73±8 岁；89%为男性，97%为 NYHA 功能分级 II/III 级，56%有房颤。纳入的患者主要为传统 PM 设备，RV 起搏比例平均为 86%。因此，这是一个 HF 进展期、基线 LVEF 较低（25±7%）、N 末端脑钠肽前体（NT-proBNP）水平较高（2231pg/ml[25th-75th 百分位数 1254-4309pg/ml]），且在过去 12 个月内 HF 住院频繁（50%）的患者队列。
与之前的 CRT 试验队列相比，BUDAPEST-CRT 升级研究纳入了年龄较大的患者，男性居多，房颤及其他合并症负担较重。此外，该队列代表了一个 HF 进展期、LVEF 较低、NT-proBNP 较高且 HF 事件频发的患者群体。
ClinicalTrials.gov NCT02270840。
