Palau Patricia, Seller Julia, Domínguez Eloy, Sastre Clara, Ramón Jose María, de La Espriella Rafael, Santas Enrique, Miñana Gema, Bodí Vicent, Sanchis Juan, Valle Alfonso, Chorro F Javier, Llácer Pau, Bayés-Genís Antoni, Núñez Julio
Cardiology Department, Hospital Clínico Universitario, Instituto de Investigación Sanitaria del Hospital Clínico Universitario de Valencia, Universitat de València, Valencia, Spain.
Cardiology Department, Hospital de Denia, Alicante, Spain.
J Am Coll Cardiol. 2021 Nov 23;78(21):2042-2056. doi: 10.1016/j.jacc.2021.08.073.
Chronotropic incompetence has shown to be associated with a decrease in exercise capacity in heart failure with preserved ejection fraction (HFpEF), yet β-blockers are commonly used in HFpEF despite the lack of robust evidence.
This study aimed to evaluate the effect of β-blocker withdrawal on peak oxygen consumption (peak Vo) in patients with HFpEF and chronotropic incompetence.
This is a multicenter, randomized, investigator-blinded, crossover clinical trial consisting of 2 treatment periods of 2 weeks separated by a washout period of 2 weeks. Patients with stable HFpEF, New York Heart Association functional classes II and III, previous treatment with β-blockers, and chronotropic incompetence were first randomized to withdrawing from (arm A: n = 26) versus continuing (arm B: n = 26) β-blocker treatment and were then crossed over to receive the opposite intervention. Changes in peak Vo and percentage of predicted peak Vo (peak Vo%) measured at the end of the trial were the primary outcome measures. To account for the paired-data nature of this crossover trial, linear mixed regression analysis was used.
The mean age was 72.6 ± 13.1 years, and most of the patients were women (59.6%) in New York Heart Association functional class II (66.7%). The mean peakVo and peak Vo% were 12.4 ± 2.9 mL/kg/min, and 72.4 ± 17.8%, respectively. No significant baseline differences were found across treatment arms. Peak Vo and peak Vo% increased significantly after β-blocker withdrawal (14.3 vs 12.2 mL/kg/min [Δ +2.1 mL/kg/min]; P < 0.001 and 81.1 vs 69.4% [Δ +11.7%]; P < 0.001, respectively).
β-blocker withdrawal improved maximal functional capacity in patients with HFpEF and chronotropic incompetence. β-blocker use in HFpEF deserves profound re-evaluation. (β-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity [PRESERVE-HR]; NCT03871803; 2017-005077-39).
变时性功能不全已被证明与射血分数保留的心力衰竭（HFpEF）患者运动能力下降有关，然而尽管缺乏有力证据，β受体阻滞剂仍常用于HFpEF患者。
本研究旨在评估停用β受体阻滞剂对HFpEF合并变时性功能不全患者峰值摄氧量（peak Vo）的影响。
这是一项多中心、随机、研究者盲法、交叉临床试验，包括两个为期2周的治疗期，中间间隔2周的洗脱期。稳定的HFpEF患者，纽约心脏协会心功能II级和III级，既往接受过β受体阻滞剂治疗且存在变时性功能不全，首先随机分为停用（A组：n = 26）或继续（B组：n = 26）β受体阻滞剂治疗，然后交叉接受相反的干预措施。试验结束时测量的peak Vo和预测peak Vo百分比（peak Vo%）的变化是主要结局指标。为了考虑该交叉试验的配对数据性质，采用线性混合回归分析。
平均年龄为72.6±13.1岁，大多数患者为女性（59.6%），纽约心脏协会心功能II级（66.7%）。平均peak Vo和peak Vo%分别为12.4±2.9 mL/kg/min和72.4±17.8%。各治疗组间基线无显著差异。停用β受体阻滞剂后，peak Vo和peak Vo%显著增加（分别为14.3 vs 12.2 mL/kg/min [Δ +2.1 mL/kg/min]；P < 0.001和81.1 vs 69.4% [Δ +11.7%]；P < 0.001）。
停用β受体阻滞剂可改善HFpEF合并变时性功能不全患者的最大功能能力。HFpEF患者使用β受体阻滞剂值得进行深入重新评估。（HFpEF合并变时性功能不全患者停用β受体阻滞剂：对功能能力的影响[PRESERVE-HR]；NCT03871803；2017-005077-39）
