Institute for Cardiovascular Research Vrije Universiteit, VU University Medical Center Amsterdam, Amsterdam, the Netherlands.
J Am Coll Cardiol. 2010 Feb 9;55(6):526-37. doi: 10.1016/j.jacc.2009.06.067.
Despite use of similar drugs, outcomes of recent heart failure (HF) trials were frequently neutral in heart failure with normal left ventricular ejection fraction (HFNEF) and positive in heart failure with reduced left ventricular ejection fraction (HFREF). The neutral outcomes of HFNEF trials were often attributed to deficient HFNEF patient recruitment with inclusion of many HFREF or noncardiac patients. Patient recruitment criteria of 21 HFNEF trials were therefore reviewed in reference to diagnostic guidelines for HFNEF. In the 4 published sets of guidelines, a definite diagnosis of HFNEF required the simultaneous and obligatory presence of signs and/or symptoms of HF and evidence of normal systolic left ventricular (LV) function and of diastolic LV dysfunction. In 3 of 4 sets of guidelines, normal systolic LV function comprised both a left ventricular ejection fraction (LVEF) >50% and an absence of LV dilation. Among the 21 HFNEF trials, LVEF cutoff values ranged from 35% to 50%, with only 8 trials adhering to an LVEF >50%. Furthermore, only 1 trial specified a normal LV end-diastolic dimension as an enrollment criterion and only 7 trials required evidence of diastolic LV dysfunction. Nonadherence to diagnostic guidelines induced excessive enrollment into HFNEF trials of HF patients with eccentric LV remodeling and ischemic heart disease compared with HF patients with concentric LV remodeling and arterial hypertension. Nonadherence to guidelines also led to underpowered HFNEF trials with a low incidence of outcome events such as death or HF hospitalizations. Future HFNEF trials should therefore adhere to diagnostic guidelines for HFNEF.
尽管使用了类似的药物，但心力衰竭伴射血分数正常（HFNEF）和心力衰竭伴射血分数降低（HFREF）的最近心力衰竭试验的结果常常在 HFNEF 中为中性，而在 HFREF 中为阳性。HFNEF 试验的中性结果通常归因于 HFNEF 患者招募不足，其中包括许多 HFREF 或非心脏患者。因此，参照 HFNEF 的诊断指南，审查了 21 项 HFNEF 试验的患者纳入标准。在 4 套已发表的指南中，HFNEF 的明确诊断需要同时且强制性地存在心力衰竭的体征和/或症状以及左心室收缩功能正常和左心室舒张功能障碍的证据。在 4 套指南中的 3 套中，正常的左心室收缩功能包括左心室射血分数（LVEF）>50%和左心室扩张缺失。在 21 项 HFNEF 试验中，LVEF 截止值范围从 35%到 50%，只有 8 项试验符合 LVEF>50%。此外，只有 1 项试验将正常的 LV 末期舒张尺寸指定为纳入标准，只有 7 项试验需要左心室舒张功能障碍的证据。与左心室向心性重构和动脉高血压的心力衰竭患者相比，诊断指南的不遵守导致 HFNEF 试验中过多地纳入了具有偏心性 LV 重构和缺血性心脏病的心力衰竭患者。不遵守指南还导致 HFNEF 试验的效力不足，其结局事件（如死亡或心力衰竭住院）的发生率较低。因此，未来的 HFNEF 试验应遵守 HFNEF 的诊断指南。
