Voors Adriaan A, Davison Beth A, Teerlink John R, Felker G Michael, Cotter Gad, Filippatos Gerasimos, Greenberg Barry H, Pang Peter S, Levin Bruce, Hua Tsushung A, Severin Thomas, Ponikowski Piotr, Metra Marco
University of Groningen, Groningen, the Netherlands.
Eur J Heart Fail. 2014 Nov;16(11):1230-40. doi: 10.1002/ejhf.170. Epub 2014 Oct 7.
We studied the characteristics and clinical outcome related to diuretic response and the effects of serelaxin in patients hospitalized for acute heart failure (AHF).
RELAX-AHF was a double-blind, placebo-controlled trial, enrolling 1161 patients admitted to hospital for AHF who were randomized to 48 h i.v infusions of placebo or serelaxin (30 µg/kg per day) within 16 h from presentation. Diuretic response was defined as Δ weight kg/[(total i.v. dose)/40 mg] + [(total oral dose)/80 mg)] furosemide (or equivalent loop diuretic dose) up to day 5. Median diuretic response was -0.42 (-1.00, -0.14) kg/40 mg. A poor diuretic response was independently associated with Western-like region (Western Europe, North America, Israel, and Poland), lower diastolic blood pressure, the absence of oedema, higher blood urea nitrogen, and lower levels of aspartate aminotransferase and potassium (all P < 0.01). Randomization to serelaxin was associated with lower doses of i.v. loop diuretics and slightly less weight loss, resulting in a neutral effect on diuretic response. Worse diuretic response was independently associated both with less relief of dyspnoea, measured with a visual analogue scale (VAS) at day 5 (primary endpoint; P = 0.0002), and with a higher risk of cardiovascular death or rehospitalization for heart failure or renal failure through day 60 (secondary endpoint, P < 0.0001), but not with increased 180-day cardiovascular mortality (P = 0.507).
In patients hospitalized for AHF, a poor diuretic response was associated with a poor in-hospital and early post-discharge clinical outcome. Serelaxin had a neutral effect on diuretic response.
NCT00520806.
我们研究了急性心力衰竭(AHF)住院患者中与利尿剂反应相关的特征和临床结局以及松弛素的作用。
RELAX-AHF是一项双盲、安慰剂对照试验,纳入1161例因AHF入院的患者,这些患者在就诊后16小时内被随机分为接受安慰剂或松弛素(30μg/kg/天)静脉输注48小时。利尿剂反应定义为至第5天体重变化量(kg)/[(静脉总剂量)/40mg]+[(口服总剂量)/80mg]呋塞米(或等效袢利尿剂剂量)。利尿剂反应中位数为-0.42(-1.00,-0.14)kg/40mg。利尿剂反应不佳与西样地区(西欧、北美、以色列和波兰)、较低的舒张压、无水肿、较高的血尿素氮以及较低的天冬氨酸转氨酶和钾水平独立相关(均P<0.01)。随机分配至松弛素组与较低剂量的静脉袢利尿剂以及略少的体重减轻相关,对利尿剂反应产生中性作用。利尿剂反应较差与第5天用视觉模拟量表(VAS)测量的呼吸困难缓解较少(主要终点;P = 0.0002)以及至第60天因心力衰竭或肾衰竭导致心血管死亡或再次住院的风险较高(次要终点,P<0.0001)独立相关,但与180天心血管死亡率增加无关(P = 0.507)。
在因AHF住院的患者中,利尿剂反应不佳与住院期间及出院后早期的临床结局不良相关。松弛素对利尿剂反应具有中性作用。
NCT00520806。