Twenty-four-hour heart rate lowering with ivabradine in chronic heart failure: insights from the SHIFT Holter substudy
Twenty-four-hour heart rate lowering with ivabradine in chronic heart failure: insights from the SHIFT Holter substudy
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DOI：
10.1002/ejhf.258
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发表时间：
2015-05-01
影响因子：
18.2
通讯作者：
Swedberg, Karl
中科院分区：
文献类型：
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作者：
Boehm, Michael;Borer, Jeffrey S.;Swedberg, Karl
目的分析24小时动态霍尔特记录是预先指定的子研究，（I-f抑制剂伊伐布雷定治疗心力衰竭试验），探索伊伐布雷定的心律安全性，并确定伊伐布雷定对24小时、日间、和夜间心率（HR）与静息办公室HR进行比较。在基线时和随机化至伊伐布雷定（n = 298）或匹配安慰剂（n = 304）后8个月进行h霍尔特监测，最大滴定剂量为7.5 mg b.i.d.。基线HR 70 b. p.m.的患者中，93%的患者接受了基于指南的优化心力衰竭治疗，包括ACE抑制剂和/或ARB，93%的患者接受了最大耐受剂量的β受体阻滞剂。8个月后，伊伐布雷定组24小时内HR从75.4 +/- 10.3 b. p.m.（P < 0.0001）降低9.5 ± 10.0 b. p.m.，安慰剂组从74.8 ± 9.7 b. p.m.（与伊伐布雷定相比差异P < 0.0001）降低1.2 ± 8.9 b. p.m.。伊伐布雷定的HR降低在静息办公室和24小时、清醒和睡眠记录中相似，对HR变异性具有有益作用，并且室上性或室性心律失常未发生有意义的增加。在8个月，21.3%的伊伐布雷定与8.5%的安慰剂有1次发作的HR 3s被确定在服用ivabradine.ConclusionIvabradine安全，显着降低HR和改善HR变异性收缩性心力衰竭患者，不诱导显着心动过缓，室性心律失常，或室上性心律失常。
AimsAnalysis of 24-h Holter recordings was a pre-specified substudy of SHIFT (Systolic Heart Failure Treatment with the I-f Inhibitor Ivabradine Trial) for exploring the heart rhythm safety of ivabradine and to determine effects of ivabradine on 24-h, daytime, and night-time heart rate (HR) compared with resting office HR.Methods and resultsThe 24-h Holter monitoring was performed at baseline and 8months after randomization to ivabradine (n = 298) or matching placebo (n = 304) titrated maximally to 7.5mg b.i.d. in patients with baseline HR 70 b.p.m. Patients received guideline-based optimized heart failure therapy including ACE inhibitors and/or ARBs in 93% and beta-blockers at maximally tolerated doses in 93%. After 8months, HR over 24h decreased by 9.510.0 b.p.m. with ivabradine, from 75.4 +/- 10.3 b.p.m. (P < 0.0001), and by 1.2 +/- 8.9 b.p.m. with placebo, from 74.8 +/- 9.7 b.p.m. (P < 0.0001 for difference vs. ivabradine). HR reduction with ivabradine was similar in resting office and in 24-h, awake, and asleep recordings, with beneficial effects on HR variability and no meaningful increases in supraventricular or ventricular arrhythmias. At 8months, 21.3% on ivabradine vs. 8.5% on placebo had 1 episode of HR 3s were identified in patients taking ivabradine.ConclusionIvabradine safely and significantly lowers HR and improves HR variability in patients with systolic heart failure, without inducing significant bradycardia, ventricular arrhythmias, or supraventricular arrhythmias.