缓释卡维地洛对射血分数保留的高血压合并心力衰竭患者的影响：一项试点随机对照试验（CARE-preserved HF）的研究方案
The effect of sustained-release CARvedilol in patients with hypErtension and heart failure with preserved ejection fraction: a study protocol for a pilot randomized controlled trial (CARE-preserved HF).
作者信息
Yoon Minjae, Park Sung-Ji, Yoo Byung-Su, Choi Dong-Ju
机构信息
Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Cardiovascular Imaging Center, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
出版信息
Front Cardiovasc Med. 2024 Apr 26;11:1375003. doi: 10.3389/fcvm.2024.1375003. eCollection 2024.
BACKGROUND
Although beta-blockers improve clinical outcomes in heart failure with reduced ejection fraction, the benefit of beta-blockers in heart failure with preserved ejection fraction (HFpEF) is uncertain. Global longitudinal strain (GLS) is a robust predictor of heart failure outcomes, and recent studies have shown that beta-blockers are associated with improved survival in those with low GLS (GLS <14%) but not in those with GLS ≥14% among patients with LVEF ≥40%. Therefore, the objective of this trial is to evaluate the effect of sustained-release carvedilol (carvedilol-SR) on the outcome [N-terminal pro-B-natriuretic peptide (NT-proBNP) concentration] in patients with hypertension and HFpEF and will assess the differential effects of these drugs on the outcome, according to the GLS categories.
METHODS
This prospective randomized double-blind multicenter trial (CARE-preserved HF) will include 100 patients with HFpEF from three tertiary hospitals in South Korea. Patients with HFpEF and hypertension aged ≥20 years who have evidence of functional and structural heart disease on echocardiography and elevated natriuretic peptide will be enrolled. Eligible participants will be randomized 1:1 to either the carvedilol-SR group ( = 50) or the placebo group ( = 50). Patients in the carvedilol-SR group will receive 8, 16, 32, or 64 mg carvedilol-SR once daily for 6 months, and the dose of carvedilol will be up-titrated at the discretion of the treating physicians. The primary efficacy outcome was the time-averaged proportional change in N-terminal pro-B-natriuretic peptide concentration from baseline to months 3 and 6. We will also evaluate the differential effects of carvedilol-SR on primary outcomes according to GLS, using a cut-off of 14% or the median value.
DISCUSSION
This randomized controlled trial will investigate the efficacy and safety of carvedilol-SR in patients with HFpEF and hypertension.
CLINICAL TRIAL REGISTRATION
ClinicalTrial.gov, identifier NCT05553314.
背景
尽管β受体阻滞剂可改善射血分数降低的心力衰竭患者的临床结局，但β受体阻滞剂在射血分数保留的心力衰竭（HFpEF）中的获益尚不确定。整体纵向应变（GLS）是心力衰竭结局的有力预测指标，最近的研究表明，在左心室射血分数（LVEF）≥40%的患者中，β受体阻滞剂与低GLS（GLS<14%）患者的生存率提高相关，但与GLS≥14%的患者无关。因此，本试验的目的是评估缓释卡维地洛（carvedilol-SR）对高血压合并HFpEF患者结局[氨基末端脑钠肽前体（NT-proBNP）浓度]的影响，并将根据GLS类别评估这些药物对结局的不同影响。
方法
这项前瞻性随机双盲多中心试验（CARE-preserved HF）将纳入来自韩国三家三级医院的100例HFpEF患者。年龄≥20岁、患有HFpEF和高血压、超声心动图有功能和结构心脏病证据且利钠肽升高的患者将被纳入。符合条件的参与者将按1:1随机分为卡维地洛-SR组（n = 50）或安慰剂组（n = 50）。卡维地洛-SR组患者将每天一次接受8、16、32或64mg卡维地洛-SR，持续6个月，卡维地洛的剂量将由治疗医生酌情上调。主要疗效结局是从基线到第3个月和第6个月氨基末端脑钠肽前体浓度的时间平均比例变化。我们还将使用14%的临界值或中位数，根据GLS评估卡维地洛-SR对主要结局的不同影响。
讨论
这项随机对照试验将研究卡维地洛-SR在HFpEF和高血压患者中的疗效和安全性。
临床试验注册
ClinicalTrial.gov，标识符NCT05553314。
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