Clinical trial NCT02929329: Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Cytokinetics
Sponsor class: INDUSTRY
First posted: 2016-10-11
Enrollment: 8256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF).

Detailed description: This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility criteria: Key Inclusion Criteria:

* Subject has provided informed consent
* Male or female, ≥ 18 to ≤ 85 years
* History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
* Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
* New York Heart Association (NYHA) class II to IV at most recent screening assessment.
* Managed with HF standard of care (SoC) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status
* Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
* Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)

Other Inclusion Criteria May apply

Key Exclusion Criteria:

* Currently receiving treatment in another investigational device or drug study, or \< 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
* Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
* Subject has known sensitivity to any of the products or components to be administered during testing

Other Exclusion Criteria May apply

Primary outcomes:
measure: Time to Cardiovascular Death or First Heart Failure Event
timeFrame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Secondary outcomes:
measure: Time to Cardiovascular Death
timeFrame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
measure: Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24
timeFrame: Baseline and Week 24
measure: Time to First Heart Failure Hospitalization
timeFrame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
measure: Time to All-cause Death
timeFrame: From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Other outcomes:
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facility: Research Site
state: Washington
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facility: Research Site
state: Washington
city: Spokane
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facility: Research Site
state: Washington
city: Huntington
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facility: Research Site
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facility: Research Site
state: West Virginia
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facility: Research Site
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facility: Research Site
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country: United States
facility: Research Site
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country: United States
facility: Research Site
state: Wisconsin
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facility: Research Site
state: Wisconsin
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facility: Research Site
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facility: Research Site
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facility: Research Site
state: Wisconsin
city: Waukesha
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Hungary
facility: Research Site
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country: Hungary
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country: Hungary
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Italy
facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Italy
facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Italy
facility: Research Site
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country: Italy
facility: Research Site
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facility: Research Site
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country: Italy
facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Torrette Di Ancona
country: Italy
facility: Research Site
city: Trieste
country: Italy
facility: Research Site
city: Vimercate MB
country: Italy
facility: Research Site
city: Ichinomiya-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagakute-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Seto-shi
country: Japan
facility: Research Site
state: Aichi
city: Asahi-shi
country: Japan
facility: Research Site
state: Chiba
city: Chiba-shi
country: Japan
facility: Research Site
state: Chiba
city: Funabashi-shi
country: Japan
facility: Research Site
state: Chiba
city: Urayasu-shi
country: Japan
facility: Research Site
state: Chiba
city: Imabari-shi
country: Japan
facility: Research Site
state: Ehime
city: Matsuyama-shi
country: Japan
facility: Research Site
state: Ehime
city: Chikushino-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kasuya-gun
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Koga-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Onga-gun
country: Japan
facility: Research Site
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Research Site
state: Fukushima
city: Fukushima-shi
country: Japan
facility: Research Site
state: Fukushima
city: Fukushima-shi
country: Japan
facility: Research Site
state: Fukushima
city: Ogaki-shi
country: Japan
facility: Research Site
state: Gifu
city: Maebashi-shi
country: Japan
facility: Research Site
state: Gunma
city: Takasaki-shi
country: Japan
facility: Research Site
state: Gunma
city: Fukuyama-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Kure-shi
country: Japan
facility: Research Site
state: Hiroshima
city: Hakodate-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Amagasaki-shi
country: Japan
facility: Research Site
state: Hyogo
city: Himeji-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kawanishi-shi
country: Japan
facility: Research Site
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Research Site
state: Hyogo
city: Takarazuka-shi
country: Japan
facility: Research Site
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: Research Site
state: Ibaraki
city: Kahoku-gun
country: Japan
facility: Research Site
state: Ishikawa
city: Kanazawa-shi
country: Japan
facility: Research Site
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Research Site
state: Iwate
city: Takamatsu-shi
country: Japan
facility: Research Site
state: Kagawa
city: Hayama
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Odawara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Research Site
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Research Site
state: Kumamoto
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi
city: Nagano-shi
country: Japan
facility: Research Site
state: Nagano
city: Kashihara-shi
country: Japan
facility: Research Site
state: Nara
city: Oita-shi
country: Japan
facility: Research Site
state: Oita
city: Okayama-shi
country: Japan
facility: Research Site
state: Okayama
city: Naha-shi
country: Japan
facility: Research Site
state: Okinawa
city: Shimajiri-gun
country: Japan
facility: Research Site
state: Okinawa
city: Urasoe-shi
country: Japan
facility: Research Site
state: Okinawa
city: Higashiosaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Matsubara-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Suita-shi
country: Japan
facility: Research Site
state: Osaka
city: Saga-shi
country: Japan
facility: Research Site
state: Saga
city: Ureshino-shi
country: Japan
facility: Research Site
state: Saga
city: Ageo-shi
country: Japan
facility: Research Site
state: Saitama
city: Koshigaya-shi
country: Japan
facility: Research Site
state: Saitama
city: Wako-shi
country: Japan
facility: Research Site
state: Saitama
city: Kusatsu-shi
country: Japan
facility: Research Site
state: Shiga
city: Sunto-gun
country: Japan
facility: Research Site
state: Shizuoka
city: Akishima-shi
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Fussa-shi
country: Japan
facility: Research Site
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Research Site
state: Tokyo
city: Kodaira-shi
country: Japan
facility: Research Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Research Site
state: Tokyo
city: Minato-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Research Site
state: Tokyo
city: Toyama-shi
country: Japan
facility: Research Site
state: Toyama
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Torreon
country: Mexico
facility: Research Site
state: Coahuila
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Pachuca
country: Mexico
facility: Research Site
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Zapopan
country: Mexico
facility: Research Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Monterrey
country: Mexico
facility: Research Site
state: Nuevo León
city: Queretaro
country: Mexico
facility: Research Site
state: Querétaro
city: San Luis Potosi
country: Mexico
facility: Research Site
state: San Luis Potosí
city: Culiacan
country: Mexico
facility: Research Site
state: Sinaloa
city: Xalapa
country: Mexico
facility: Research Site
state: Veracruz
city: Aguascalientes
country: Mexico
facility: Research Site
city: 's Hertogenbosch
country: Netherlands
facility: Research Site
city: Almelo
country: Netherlands
facility: Research Site
city: Arnhem
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Capelle Aan De IJssel
country: Netherlands
facility: Research Site
city: Den Helder
country: Netherlands
facility: Research Site
city: Deventer
country: Netherlands
facility: Research Site
city: Doetinchem
country: Netherlands
facility: Research Site
city: Emmen
country: Netherlands
facility: Research Site
city: Goes
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Leiderdorp
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Tiel
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Uden
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Papatoetoe, Auckland
country: New Zealand
facility: Research Site
city: Takapuna, Auckland
country: New Zealand
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Gizycko
country: Poland
facility: Research Site
city: Kazimierza Wielka
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Klodzko
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Miechow
country: Poland
facility: Research Site
city: Olawa
country: Poland
facility: Research Site
city: Piotrkow Trybunalski
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Ruda Slaska
country: Poland
facility: Research Site
city: Skierniewice
country: Poland
facility: Research Site
city: Stalowa Wola
country: Poland
facility: Research Site
city: Swidnik
country: Poland
facility: Research Site
city: Tarnow
country: Poland
facility: Research Site
city: Torun
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wloclawek
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Aveiro
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Covilha
country: Portugal
facility: Research Site
city: Guimaraes
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Bucarest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Targoviste
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Ivanovo
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Korolev
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Lomonosov
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Village Novoseltsy
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bardejov
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Brezno
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Nitra
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Rimavska Sobota
country: Slovakia
facility: Research Site
city: Snina
country: Slovakia
facility: Research Site
city: Svidnik
country: Slovakia
facility: Research Site
city: Trnava
country: Slovakia
facility: Research Site
city: Bloemfontein
country: South Africa
facility: Research Site
state: Free State
city: Parktown
country: South Africa
facility: Research Site
state: Gauteng
city: Soweto
country: South Africa
facility: Research Site
state: Gauteng
city: Sunninghill
country: South Africa
facility: Research Site
state: Gauteng
city: Durban
country: South Africa
facility: Research Site
state: KwaZulu-Natal
city: Umhlanga
country: South Africa
facility: Research Site
state: KwaZulu-Natal
city: Parow
country: South Africa
facility: Research Site
state: Western Cape
city: Somerset West
country: South Africa
facility: Research Site
state: Western Cape
city: Worcester
country: South Africa
facility: Research Site
state: Western Cape
city: Cordoba
country: Spain
facility: Research Site
state: Andalucía
city: Granada
country: Spain
facility: Research Site
state: Andalucía
city: Malaga
country: Spain
facility: Research Site
state: Andalucía
city: Sevilla
country: Spain
facility: Research Site
state: Andalucía
city: Ubeda
country: Spain
facility: Research Site
state: Andalucía
city: Zaragoza
country: Spain
facility: Research Site
state: Aragón
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: La laguna
country: Spain
facility: Research Site
state: Canarias
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Valladolid
country: Spain
facility: Research Site
state: Castilla León
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Research Site
state: Comunidad Valenciana
city: A Coruña
country: Spain
facility: Research Site
state: Galicia
city: Santiago de Compostela
country: Spain
facility: Research Site
state: Galicia
city: Vigo
country: Spain
facility: Research Site
state: Galicia
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: El Palmar
country: Spain
facility: Research Site
state: Murcia
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Jonkoping
country: Sweden
facility: Research Site
city: Lidköping
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
city: Skelleftea
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Fribourg
country: Switzerland
facility: Research Site
city: Geneva 14
country: Switzerland
facility: Research Site
city: Lausanne
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Afyonkarahisar
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Corum
country: Turkey
facility: Research Site
city: Eskisehir
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kirikkale
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Konya
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Sakarya
country: Turkey
facility: Research Site
city: Sivas
country: Turkey
facility: Research Site
city: Van
country: Turkey
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsya
country: Ukraine
facility: Research Site
city: Zaporizhzhia
country: Ukraine
facility: Research Site
city: Zaporizhzhya
country: Ukraine
facility: Research Site
city: Ayr
country: United Kingdom
facility: Research Site
city: Basingstoke
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Dudley
country: United Kingdom
facility: Research Site
city: Dundee
country: United Kingdom
facility: Research Site
city: Exeter
country: United Kingdom
facility: Research Site
city: Gillingham
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harlow
country: United Kingdom
facility: Research Site
city: High Wycombe
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Merthyr Tydfil
country: United Kingdom
facility: Research Site
city: Newport
country: United Kingdom
facility: Research Site
city: Northampton
country: United Kingdom
facility: Research Site
city: Northwood
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Portsmouth
country: United Kingdom
facility: Research Site
city: Romford
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Shipley
country: United Kingdom
facility: Research Site
city: Sidcup
country: United Kingdom
facility: Research Site
city: Solihull
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Sunderland
country: United Kingdom
facility: Research Site
city: Swindon
country: United Kingdom
facility: Research Site
city: Taunton
country: United Kingdom
facility: Research Site
city: Torquay
country: United Kingdom
facility: Research Site
city: Worcester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sorensen T, Bohm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17.
citation: Solomon SD, Claggett BL, Miao ZM, Diaz R, Felker GM, McMurray JJV, Metra M, Corbalan R, Filippatos G, Goudev AR, Mareev V, Serpytis P, Suter T, Yilmaz MB, Zannad F, Kupfer S, Heitner SB, Malik FI, Teerlink JR. Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. Eur Heart J. 2022 Jun 14;43(23):2212-2220. doi: 10.1093/eurheartj/ehac144.
citation: Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlstrom U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsanyi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Jan 1;7(1):26-34. doi: 10.1001/jamacardio.2021.4027.
citation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, 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, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.
citation: Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Buchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6.