PMID- 32985088
OWN - NLM
STAT- MEDLINE
DCOM- 20210609
LR  - 20211221
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Print)
IS  - 1388-9842 (Linking)
VI  - 22
IP  - 11
DP  - 2020 Nov
TI  - Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction: 
      GALACTIC-HF baseline characteristics and comparison with contemporary clinical 
      trials.
PG  - 2160-2171
LID - 10.1002/ejhf.2015 [doi]
AB  - AIMS: 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. METHODS AND RESULTS: 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 m(2) (n = 528), and treated with sacubitril/valsartan at 
      baseline (n = 1594). CONCLUSIONS: 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.
CI  - (c) 2020 The Authors. European Journal of Heart Failure published by John Wiley & 
      Sons Ltd on behalf of European Society of Cardiology.
FAU - Teerlink, John R
AU  - Teerlink JR
AD  - Section of Cardiology, San Francisco Veterans Affairs Medical Center and School 
      of Medicine, University of California San Francisco, San Francisco, CA, USA.
FAU - Diaz, Rafael
AU  - Diaz R
AD  - Estudios Clinicos Latino America (ECLA), Rosario, Argentina.
FAU - Felker, G Michael
AU  - Felker GM
AD  - Division of Cardiology, Duke University School of Medicine and Duke Clinical 
      Research Institute, Durham, NC, USA.
FAU - McMurray, John J V
AU  - McMurray JJV
AD  - British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 
      Glasgow, UK.
FAU - Metra, Marco
AU  - Metra M
AD  - Cardiology, ASST Spedali Civili; Department of Medical and Surgical Specialties, 
      Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.
FAU - Solomon, Scott D
AU  - Solomon SD
AD  - Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard 
      Medical School, Boston, MA, USA.
FAU - Adams, Kirkwood F
AU  - Adams KF
AD  - University of North Carolina, Chapel Hill, NC, USA.
FAU - Anand, Inder
AU  - Anand I
AD  - University of Minnesota, Minneapolis, MN, USA.
FAU - Arias-Mendoza, Alexandra
AU  - Arias-Mendoza A
AD  - Instituto Nacional de Cardiologia, Mexico City, Mexico.
FAU - Biering-Sorensen, Tor
AU  - Biering-Sorensen T
AD  - Department of Cardiology, Herlev & Gentofte Hospital & Department of Biomedical 
      Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, 
      Copenhagen, Denmark.
FAU - Bohm, Michael
AU  - Bohm M
AD  - Saarland University, Universitatsklinikum des Saarlandes, Homburg, Germany.
FAU - Bonderman, Diana
AU  - Bonderman D
AD  - Medical University of Vienna, Vienna, Austria.
FAU - Cleland, John G F
AU  - Cleland JGF
AD  - National Heart and Lung Institute, Imperial College, London, UK.
AD  - Robertson Centre for Biostatistics and Clinical Trials, Institute of Health and 
      Wellbeing, University of Glasgow, Glasgow, UK.
FAU - Corbalan, Ramon
AU  - Corbalan R
AD  - Pontificia Universidad Catolica de Chile, Santiago, Chile.
FAU - Crespo-Leiro, Maria G
AU  - Crespo-Leiro MG
AD  - Complexo Hospitalario Universitario A Coruna (CHUAC). CIBERCV. INIBIC. 
      Universidade da Coruna, A Coruna, Spain.
FAU - Dahlstrom, Ulf
AU  - Dahlstrom U
AD  - Department of Cardiology and Department of Health, Medicine and Caring Sciences, 
      Linkoping University, Linkoping, Sweden.
FAU - Echeverria Correa, Luis E
AU  - Echeverria Correa LE
AD  - Fundacion Cardiovascular de Colombia, Floridablanca, Colombia.
FAU - Fang, James C
AU  - Fang JC
AD  - University of Utah, Salt Lake City, UT, USA.
FAU - Filippatos, Gerasimos
AU  - Filippatos G
AD  - University of Athens, Athens, Greece.
FAU - Fonseca, Candida
AU  - Fonseca C
AD  - Hospital S. Francisco Xavier, CHLO; NOVA Medical School, Faculdade de Ciencias 
      Medicas, Universidade Nova de Lisboa, Lisbon, Portugal.
FAU - Goncalvesova, Eva
AU  - Goncalvesova E
AD  - Commenius Universtity, Bratislava, Slovakia.
FAU - Goudev, Assen R
AU  - Goudev AR
AD  - Department of Cardiology, Queen Giovanna University Hospital and Medical 
      University, Sofia, Bulgaria.
FAU - Howlett, Jonathan G
AU  - Howlett JG
AD  - Libin Cardiovascular Institute and Cumming School of Medicine, University of 
      Calgary, Calgary, Canada.
FAU - Lanfear, David E
AU  - Lanfear DE
AD  - Henry Ford Heart and Vascular Institute, Detroit, MI, USA.
FAU - Lund, Mayanna
AU  - Lund M
AD  - Middlemore Hospital, Auckland, New Zealand.
FAU - Macdonald, Peter
AU  - Macdonald P
AD  - St. Vincent's Hospital Sydney, Darlinghurst, Australia.
FAU - Mareev, Vyacheslav
AU  - Mareev V
AD  - University Clinic of Lomonosov Moscow State University, Moscow, Russia.
FAU - Momomura, Shin-Ichi
AU  - Momomura SI
AD  - Saitama Citizens Medical Center, Saitama, Japan.
FAU - O'Meara, Eileen
AU  - O'Meara E
AD  - Montreal Heart Institute and Universite de Montreal, Montreal, Canada.
FAU - Parkhomenko, Alexander
AU  - Parkhomenko A
AD  - Institute of Cardiology, Kyiv, Ukraine.
FAU - Ponikowski, Piotr
AU  - Ponikowski P
AD  - Wroclaw Medical University, Wroclaw, Poland.
FAU - Ramires, Felix J A
AU  - Ramires FJA
AD  - Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de 
      Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
FAU - Serpytis, Pranas
AU  - Serpytis P
AD  - Vilnius University, Vilnius, Lithuania.
FAU - Sliwa, Karen
AU  - Sliwa K
AD  - University of Cape Town, Johannesburg, South Africa.
FAU - Spinar, Jindrich
AU  - Spinar J
AD  - University Hospital Brno, Brno, Czech Republic.
FAU - Suter, Thomas M
AU  - Suter TM
AD  - Bern University Hospital, University of Bern, Bern, Switzerland.
FAU - Tomcsanyi, Janos
AU  - Tomcsanyi J
AD  - St. John of God Hospital, Budapest, Hungary.
FAU - Vandekerckhove, Hans
AU  - Vandekerckhove H
AD  - AZ Sint-Lucas, Ghent, Belgium.
FAU - Vinereanu, Dragos
AU  - Vinereanu D
AD  - University of Medicine and Pharmacy Carol Davila, University and Emergency 
      Hospital, Bucharest, Romania.
FAU - Voors, Adriaan A
AU  - Voors AA
AD  - University of Groningen, Groningen, The Netherlands.
FAU - Yilmaz, Mehmet B
AU  - Yilmaz MB
AD  - Dokuz Eylul University, Izmir, Turkey.
FAU - Zannad, Faiez
AU  - Zannad F
AD  - Universite de Lorraine, Inserm INI CRCT, CHRU Nancy, Nancy, France.
FAU - Sharpsten, Lucie
AU  - Sharpsten L
AD  - Amgen, Inc., Thousand Oaks, CA, USA.
FAU - Legg, Jason C
AU  - Legg JC
AD  - Amgen, Inc., Thousand Oaks, CA, USA.
FAU - Abbasi, Siddique A
AU  - Abbasi SA
AD  - Amgen, Inc., Thousand Oaks, CA, USA.
FAU - Varin, Claire
AU  - Varin C
AD  - Servier, Suresnes, France.
FAU - Malik, Fady I
AU  - Malik FI
AD  - Cytokinetics, Inc., South San Francisco, CA, USA.
FAU - Kurtz, Christopher E
AU  - Kurtz CE
AD  - Amgen, Inc., Thousand Oaks, CA, USA.
CN  - GALACTIC-HF Investigators
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20201027
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
RN  - 2M19539ERK (omecamtiv mecarbil)
RN  - 8W8T17847W (Urea)
SB  - IM
EIN - Eur J Heart Fail. 2022 Mar;24(3):591. PMID: 34931409
MH  - Aged
MH  - Female
MH  - *Heart Failure/drug therapy/physiopathology
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Randomized Controlled Trials as Topic
MH  - Stroke Volume/drug effects
MH  - Urea/*analogs & derivatives/therapeutic use
MH  - Ventricular Function, Left/drug effects
PMC - PMC7756903
OTO - NOTNLM
OT  - Cardiac myosin activator
OT  - Cardiovascular outcomes trial
OT  - Heart failure
OT  - Inotrope
OT  - Myotrope
OT  - Omecamtiv mecarbil
EDAT- 2020/09/29 06:00
MHDA- 2021/06/10 06:00
PMCR- 2020/10/27
CRDT- 2020/09/28 05:51
PHST- 2020/08/29 00:00 [received]
PHST- 2020/09/17 00:00 [revised]
PHST- 2020/09/20 00:00 [accepted]
PHST- 2020/09/29 06:00 [pubmed]
PHST- 2021/06/10 06:00 [medline]
PHST- 2020/09/28 05:51 [entrez]
PHST- 2020/10/27 00:00 [pmc-release]
AID - EJHF2015 [pii]
AID - 10.1002/ejhf.2015 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2020 Nov;22(11):2160-2171. doi: 10.1002/ejhf.2015. Epub 2020 
      Oct 27.