Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials.
Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: GALACTIC-HF baseline characteristics and comparison with contemporary clinical trials.
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DOI：
10.1002/ejhf.2015
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发表时间：
2020-11
影响因子：
18.2
通讯作者：
GALACTIC-HF Investigators
中科院分区：
文献类型：
--
作者：
Teerlink JR;Diaz R;Felker GM;McMurray JJV;Metra M;Solomon SD;Adams KF;Anand I;Arias-Mendoza A;Biering-Sørensen T;Böhm M;Bonderman D;Cleland JGF;Corbalan R;Crespo-Leiro MG;Dahlström U;Echeverria Correa LE;Fang JC;Filippatos G;Fonseca C;Goncalvesova E;Goudev AR;Howlett JG;Lanfear DE;Lund M;Macdonald P;Mareev V;Momomura SI;O'Meara E;Parkhomenko A;Ponikowski P;Ramires FJA;Serpytis P;Sliwa K;Spinar J;Suter TM;Tomcsanyi J;Vandekerckhove H;Vinereanu D;Voors AA;Yilmaz MB;Zannad F;Sharpsten L;Legg JC;Abbasi SA;Varin C;Malik FI;Kurtz CE;GALACTIC-HF Investigators
新型选择性心肌肌球蛋白激活剂奥马环素（omecamtiv mecarbil）在射血分数降低的心力衰竭（HFrEF）患者中的安全性和有效性正在“通过改善心力衰竭收缩性降低不良心脏结局的全球方法”（GALACTIC - HF）试验中进行测试。在此，我们描述了GALACTIC - HF试验参与者的基线特征，并将其与其他同期试验进行比较。
确诊为HFrEF、纽约心脏协会（NYHA）心功能分级≥II级、射血分数≤35%、利钠肽升高，且当前因心力衰竭住院或一年内有心力衰竭住院/急诊就诊史的成年人被随机分配接受安慰剂或奥马环素（药代动力学指导剂量：25、37.5或50mg，每日两次）。共有8256名患者[男性（79%），非白人（22%），平均年龄65岁]入组，平均射血分数为27%，缺血性病因占54%，NYHA II级占53%，III/IV级占47%，N - 末端B型利钠肽原中位数为1971 pg/mL。基线时的心力衰竭治疗在当代心力衰竭试验中属于应用最有效的情况之一。GALACTIC - HF随机纳入的患者代表了近期的心力衰竭登记研究和试验，其中大量患者还具有以往试验中未充分研究的特征，包括更多来自北美的患者（n = 1386）、作为住院患者入组（n = 2084）、收缩压<100 mmHg（n = 1127）、估计肾小球滤过率<30 mL/min/1.73 m²（n = 528）以及基线时接受沙库巴曲/缬沙坦治疗（n = 1594）。
GALACTIC - HF从住院和门诊环境中纳入了一个治疗良好的高危人群，这将对这种新型疗法的有效性和安全性进行明确评估，并为其未来可能的应用提供信息。
GALACTIC - HF试验设计、入组和基线特征的图示。ACEi，血管紧张素转换酶抑制剂；ARB，血管紧张素受体阻滞剂；ARNi，血管紧张素受体 - 脑啡肽酶抑制剂；CRT，心脏再同步化治疗（双心室起搏器）；CV，心血管；EF，射血分数；HFrEF，射血分数降低的心力衰竭；ICD，植入式心律转复除颤器；NT - proBNP，N - 末端B型利钠肽原；NYHA，纽约心脏协会；SBP，收缩压
The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is being tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Adults with established HFrEF, New York Heart Association (NYHA) functional class ≥II, ejection fraction ≤35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization/emergency department visit for heart failure within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5, or 50 mg bid). A total of 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean ejection fraction 27%, ischaemic aetiology in 54%, NYHA class II 53% and III/IV 47%, and median N‐terminal pro‐B‐type natriuretic peptide 1971 pg/mL. Heart failure therapies at baseline were among the most effectively employed in contemporary heart failure trials. GALACTIC‐HF randomized patients representative of recent heart failure registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure <100 mmHg (n = 1127), estimated glomerular filtration rate <30 mL/min/1.73 m2 (n = 528), and treated with sacubitril/valsartan at baseline (n = 1594). GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation. Graphical representation of the GALACTIC‐HF trial design, enrolment and baseline characteristics. ACEi, angiotensin‐converting enzyme inhibitor; ARB, angiotensin receptor blocker; ARNi, angiotensin receptor–neprilysin inhibitor; CRT, cardiac resynchronization therapy (biventricular pacemaker); CV, cardiovascular; EF, ejection fraction; HFrEF, heart failure with reduced ejection fraction; ICD, implantable cardioverter defibrillator; NT‐proBNP, N‐terminal pro‐B‐type natriuretic peptide; NYHA, Hew York Heart Association; SBP, systolic blood pressure.
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影响因子：
18.2
作者：
Chioncel, Ovidiu;Lainscak, Mitja;Filippatos, Gerasimos
通讯作者：
Filippatos, Gerasimos
影响因子：
34.3
作者：
Teng, Tiew-Hwa K.;Tromp, Jasper;Lam, Carolyn S. P.
通讯作者：
Lam, Carolyn S. P.
DOI：
10.1126/science.1200113
发表时间：
2011-03-18
期刊：
Science (New York, N.Y.)
影响因子：
--
作者：
Malik FI;Hartman JJ;Elias KA;Morgan BP;Rodriguez H;Brejc K;Anderson RL;Sueoka SH;Lee KH;Finer JT;Sakowicz R;Baliga R;Cox DR;Garard M;Godinez G;Kawas R;Kraynack E;Lenzi D;Lu PP;Muci A;Niu C;Qian X;Pierce DW;Pokrovskii M;Suehiro I;Sylvester S;Tochimoto T;Valdez C;Wang W;Katori T;Kass DA;Shen YT;Vatner SF;Morgans DJ
通讯作者：
Morgans DJ
影响因子：
13
作者：
Vaduganathan, Muthiah;Claggett, Brian;Solomon, Scott D.
通讯作者：
Solomon, Scott D.
影响因子：
120.7
作者：
Gheorghiade, Mihai;Boehm, Michael;Maggioni, Aldo P.
通讯作者：
Maggioni, Aldo P.