Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Tottori University, Nishi-cho, Yonago, Japan.
Eur J Heart Fail. 2013 Jan;15(1):110-8. doi: 10.1093/eurjhf/hfs141. Epub 2012 Sep 14.
The therapeutic strategy for heart failure with preserved ejection fraction (HFPEF) has not been established. The Japanese Diastolic Heart Failure Study (J-DHF) is a multicentre, prospective, randomized, open, blinded-endpoint trial, designed to assess the effects of carvedilol in HFPEF patients.
A total of 245 patients with heart failure and ejection fraction >40% were randomly assigned into those treated with (carvedilol group, n = 120) and without carvedilol (control group, n = 125). The primary outcome is a composite of cardiovascular death and unplanned hospitalization for heart failure. During a median follow-up of 3.2 years, the primary endpoint occurred in 29 patients in the carvedilol group and in 34 patients in the control group [adjusted hazard ratio (HR) 0.902, 95% confidence interval (CI) 0.546-1.488, P = 0.6854]. Another major composite endpoint, cardiovascular death and unplanned hospitalization for any cardiovascular causes, occurred in 38 patients of the carvedilol group and 52 patients of the control group (HR 0.768, 95% CI 0.504-1.169; P = 0.2178). The target dose of carvedilol was 20 mg/day, but the median prescribed dose was 7.5 mg/day. In the patients treated with standard doses (carvedilol >7.5 mg/day, n = 58), this composite outcome was significantly less than in the controls (HR 0.539, 95% CI 0.303-0.959; P = 0.0356), whereas it was comparable with the controls in the patients treated with carvedilol ≤7.5 mg/day (n = 62, HR 1.070, 95% CI 0.650-1.763; P = 0.7893).
Carvedilol did not improve prognosis of HFPEF patients overall; however, the standard dose, not the low dose, prescription might be effective. This may facilitate further investigation. UMIN number: C000000318.
射血分数保留的心衰（HFPEF）的治疗策略尚未确定。日本舒张性心力衰竭研究（J-DHF）是一项多中心、前瞻性、随机、开放、盲终点试验，旨在评估卡维地洛在 HFPEF 患者中的疗效。
共有 245 名射血分数>40%的心衰患者被随机分为卡维地洛治疗组（n=120）和对照组（n=125）。主要终点是心血管死亡和心力衰竭计划外住院的复合终点。中位随访 3.2 年后，卡维地洛组有 29 例患者发生主要终点，对照组有 34 例患者发生主要终点[校正后的风险比（HR）0.902，95%置信区间（CI）0.546-1.488，P=0.6854]。卡维地洛组有 38 例患者和对照组有 52 例患者发生另一个主要复合终点，即心血管死亡和任何心血管原因计划外住院[HR 0.768，95%CI 0.504-1.169；P=0.2178]。卡维地洛的目标剂量为 20mg/天，但中位处方剂量为 7.5mg/天。在接受标准剂量治疗的患者（卡维地洛>7.5mg/天，n=58）中，该复合结局显著低于对照组（HR 0.539，95%CI 0.303-0.959；P=0.0356），而在接受卡维地洛≤7.5mg/天治疗的患者中，该复合结局与对照组相当（n=62，HR 1.070，95%CI 0.650-1.763；P=0.7893）。
卡维地洛并未改善 HFPEF 患者的总体预后；然而，标准剂量而非低剂量处方可能有效。这可能有助于进一步的研究。UMIN 编号：C000000318。
