Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

Heart Failure Clinical Trial

— GALACTIC-HF  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02929329
• Other study ID #: 20110203
• Secondary ID: 2016-002299-28
• Status: Completed
• Phase: Phase 3
• Start date: January 6, 2017
• Est. completion date: September 14, 2020

Study information

• Verified date: November 2021
• Source: Cytokinetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8256
• Est. completion date: September 14, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Omecamtiv Mecarbil
Omecamtiv mecarbil tablets for oral administration
• Placebo
Matching placebo tablets
• Standard of Care
Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.

Locations

Country	Name	City	State
Argentina	Research Site	Bahia Blanca	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba	Buenos Aires
Argentina	Research Site	Caba	Buenos Aires
Argentina	Research Site	Caba	Buenos Aires
Argentina	Research Site	Caba	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Cordoba	Córdoba
Argentina	Research Site	Córdoba
Argentina	Research Site	Córdoba
Argentina	Research Site	Córdoba
Argentina	Research Site	Coronel Suarez	Buenos Aires
Argentina	Research Site	Corrientes
Argentina	Research Site	Corrientes
Argentina	Research Site	Mar del Plata	Buenos Aires
Argentina	Research Site	Merlo	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	Ramos Meija	Buenos Aires
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Rosario	Santa Fe
Argentina	Research Site	Salta
Argentina	Research Site	San Fernando	Buenos Aires
Argentina	Research Site	San Isidro	Buenos Aires
Argentina	Research Site	San Martin	Buenos Aires
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Argentina	Research Site	San Nicolas	Buenos Aires
Argentina	Research Site	Santa Fe
Argentina	Research Site	Santa Rosa	La Pampa
Argentina	Research Site	Venado Tuerto	Santa Fe
Argentina	Research Site	Villa Maria	Córdoba
Australia	Research Site	Ashford	South Australia
Australia	Research Site	Bedford Park	South Australia
Australia	Research Site	Bundoora	Victoria
Australia	Research Site	Chermside	Queensland
Australia	Research Site	Concord	New South Wales
Australia	Research Site	Darlinghurst	New South Wales
Australia	Research Site	Frankston	Victoria
Australia	Research Site	Fullarton	South Australia
Australia	Research Site	Garran	Australian Capital Territory
Australia	Research Site	Geelong	Victoria
Australia	Research Site	Herston	Queensland
Australia	Research Site	Liverpool	New South Wales
Australia	Research Site	Murdoch	Western Australia
Australia	Research Site	New Lambton Heights	New South Wales
Australia	Research Site	Richmond	Victoria
Australia	Research Site	Woodville South	South Australia
Australia	Research Site	Woolloongabba	Queensland
Austria	Research Site	Feldkirch
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Linz
Austria	Research Site	Linz
Austria	Research Site	Sankt Poelten
Austria	Research Site	Villach
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Aalst
Belgium	Research Site	Genk
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Belgium	Research Site	Lodelinsart
Belgium	Research Site	Roeselare
Brazil	Research Site	Aracaju	Sergipe
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Belo Horizonte	Minas Gerais
Brazil	Research Site	Brasilia	Distrito Federal
Brazil	Research Site	Campinas	São Paulo
Brazil	Research Site	Campinas	São Paulo
Brazil	Research Site	Campinas	São Paulo
Brazil	Research Site	Canoas	Rio Grande Do Sul
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Curitiba	Paraná
Brazil	Research Site	Goiania	Goiás
Brazil	Research Site	Goiania	Goiás
Brazil	Research Site	Londrina	Paraná
Brazil	Research Site	Marilia	São Paulo
Brazil	Research Site	Natal	Rio Grande Do Norte
Brazil	Research Site	Passo Fundo	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Porto Alegre	Rio Grande Do Sul
Brazil	Research Site	Ribeirao Preto	São Paulo
Brazil	Research Site	Rio De Janeiro
Brazil	Research Site	Sao Jose do Rio Preto	São Paulo
Brazil	Research Site	São José do Rio Preto	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	Sao Paulo	São Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	São Paulo
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Bulgaria	Research Site	Haskovo
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Colombia	Research Site	Medellin	Antioquia
Colombia	Research Site	Medellin	Antioquia
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Czechia	Research Site	Beroun
Czechia	Research Site	Brandys nad Labem
Czechia	Research Site	Brno
Czechia	Research Site	Brno
Czechia	Research Site	Brno
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Czechia	Research Site	Frydek Mistek
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Czechia	Research Site	Praha 5 - Smichov
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Czechia	Research Site	Zlin
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Denmark	Research Site	Aalborg
Denmark	Research Site	Aarhus N
Denmark	Research Site	Esbjerg
Denmark	Research Site	Glostrup
Denmark	Research Site	Hellerup
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Denmark	Research Site	Svendborg
France	Research Site	Beziers cedex
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France	Research Site	Chambray les Tours
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France	Research Site	Limoges Cedex
France	Research Site	Lyon Cedex 03
France	Research Site	Montauban
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France	Research Site	Nantes Cedex 1
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France	Research Site	Nimes cedex 9
France	Research Site	Paris
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France	Research Site	Paris Cedex 13
France	Research Site	Pessac Cedex
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France	Research Site	Rennes Cedex 9
France	Research Site	Saint Denis
France	Research Site	Toulon Cedex
France	Research Site	Toulouse Cedex 9
France	Research Site	Tourcoing cedex
France	Research Site	Valenciennes
Germany	Research Site	Bad Neuheim
Germany	Research Site	Berlin
Germany	Research Site	Dortmund
Germany	Research Site	Düsseldorf
Germany	Research Site	Erfurt
Germany	Research Site	Erfurt
Germany	Research Site	Essen
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Freiburg
Germany	Research Site	Göttingen
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Germany	Research Site	Homburg
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Greece	Research Site	Alexandroupoli
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Chaidari, Athens
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Greece	Research Site	Heraklion
Greece	Research Site	Ioannina
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Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Hungary	Research Site	Balatonfured
Hungary	Research Site	Bekescsaba
Hungary	Research Site	Berettyoujfalu
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
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Hungary	Research Site	Budapest
Hungary	Research Site	Cegled
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Hungary	Research Site	Szentes
Hungary	Research Site	Szolnok
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Italy	Research Site	Ariccia
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Italy	Research Site	Bergamo
Italy	Research Site	Bologna
Italy	Research Site	Brescia
Italy	Research Site	Cagliari
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Italy	Research Site	Cona FE
Italy	Research Site	Cuneo
Italy	Research Site	Foggia
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Monza
Italy	Research Site	Monza (MB)
Italy	Research Site	Napoli
Italy	Research Site	Palermo
Italy	Research Site	Pavia
Italy	Research Site	Perugia
Italy	Research Site	Piacenza
Italy	Research Site	Rimini
Italy	Research Site	Roma
Italy	Research Site	Rozzano MI
Italy	Research Site	Seriate
Italy	Research Site	Siena
Italy	Research Site	Torrette Di Ancona
Italy	Research Site	Trieste
Italy	Research Site	Vimercate MB
Japan	Research Site	Ageo-shi	Saitama
Japan	Research Site	Akishima-shi	Tokyo
Japan	Research Site	Amagasaki-shi	Hyogo
Japan	Research Site	Asahi-shi	Chiba
Japan	Research Site	Bunkyo-ku	Tokyo
Japan	Research Site	Bunkyo-ku	Tokyo
Japan	Research Site	Chiba-shi	Chiba
Japan	Research Site	Chikushino-shi	Fukuoka
Japan	Research Site	Chuo-ku	Tokyo
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukuoka-shi	Fukuoka
Japan	Research Site	Fukushima-shi	Fukushima
Japan	Research Site	Fukushima-shi	Fukushima
Japan	Research Site	Fukushima-shi	Fukushima
Japan	Research Site	Fukuyama-shi	Hiroshima
Japan	Research Site	Funabashi-shi	Chiba
Japan	Research Site	Fussa-shi	Tokyo
Japan	Research Site	Hachioji-shi	Tokyo
Japan	Research Site	Hakodate-shi	Hokkaido
Japan	Research Site	Hayama	Kanagawa
Japan	Research Site	Higashiibaraki-gun	Ibaraki
Japan	Research Site	Higashiosaka-shi	Osaka
Japan	Research Site	Himeji-shi	Hyogo
Japan	Research Site	Hiroshima-shi	Hiroshima
Japan	Research Site	Ichinomiya-shi	Aichi
Japan	Research Site	Imabari-shi	Ehime
Japan	Research Site	Itabashi-ku	Tokyo
Japan	Research Site	Kahoku-gun	Ishikawa
Japan	Research Site	Kanazawa-shi	Ishikawa
Japan	Research Site	Kashihara-shi	Nara
Japan	Research Site	Kasuya-gun	Fukuoka
Japan	Research Site	Kawanishi-shi	Hyogo
Japan	Research Site	Kawasaki-shi	Kanagawa
Japan	Research Site	Kawasaki-shi	Kanagawa
Japan	Research Site	Kawasaki-shi	Kanagawa
Japan	Research Site	Kitakyushu-shi	Fukuoka
Japan	Research Site	Kitakyushu-shi	Fukuoka
Japan	Research Site	Kitakyushu-shi	Fukuoka
Japan	Research Site	Kodaira-shi	Tokyo
Japan	Research Site	Koga-shi	Fukuoka
Japan	Research Site	Koshigaya-shi	Saitama
Japan	Research Site	Kumamoto-shi	Kumamoto
Japan	Research Site	Kure-shi	Hiroshima
Japan	Research Site	Kurume-shi	Fukuoka
Japan	Research Site	Kurume-shi	Fukuoka
Japan	Research Site	Kusatsu-shi	Shiga
Japan	Research Site	Maebashi-shi	Gunma
Japan	Research Site	Matsubara-shi	Osaka
Japan	Research Site	Matsuyama-shi	Ehime
Japan	Research Site	Meguro-ku	Tokyo
Japan	Research Site	Minato-ku	Tokyo
Japan	Research Site	Morioka-shi	Iwate
Japan	Research Site	Nagakute-shi	Aichi
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Japan	Research Site	Naha-shi	Okinawa
Japan	Research Site	Nankoku-shi	Kochi
Japan	Research Site	Nishinomiya-shi	Hyogo
Japan	Research Site	Odawara-shi	Kanagawa
Japan	Research Site	Ogaki-shi	Gifu
Japan	Research Site	Oita-shi	Oita
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Japan	Research Site	Onga-gun	Fukuoka
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United States	Research Site	Phoenix	Arizona
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United States	Research Site	Plano	Texas
United States	Research Site	Port Gibson	Mississippi
United States	Research Site	Portland	Maine
United States	Research Site	Powell	Tennessee
United States	Research Site	Prince Frederick	Maryland
United States	Research Site	Providence	Rhode Island
United States	Research Site	Providence	Rhode Island
United States	Research Site	Puyallup	Washington
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Redondo Beach	California
United States	Research Site	Reno	Nevada
United States	Research Site	Richmond	Indiana
United States	Research Site	Richmond	Virginia
United States	Research Site	Richmond	Virginia
United States	Research Site	Richmond	Virginia
United States	Research Site	Ridgewood	New Jersey
United States	Research Site	Riverside	California
United States	Research Site	Rochester	New York
United States	Research Site	Rock Hill	South Carolina
United States	Research Site	Roslyn	New York
United States	Research Site	Royal Oak	Michigan
United States	Research Site	Sacramento	California
United States	Research Site	Saginaw	Michigan
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Paul	Minnesota
United States	Research Site	Salisbury	Maryland
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Francisco	California
United States	Research Site	San Pedro	California
United States	Research Site	Sandusky	Ohio
United States	Research Site	Santa Ana	California
United States	Research Site	Santa Rosa	California
United States	Research Site	Sarasota	Florida
United States	Research Site	Saratoga Springs	New York
United States	Research Site	Sayre	Pennsylvania
United States	Research Site	Scarborough	Maine
United States	Research Site	Scottsboro	Alabama
United States	Research Site	Seattle	Washington
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Smyrna	Georgia
United States	Research Site	Somerset	New Jersey
United States	Research Site	Spokane	Washington
United States	Research Site	Springfield	Missouri
United States	Research Site	Stamford	Connecticut
United States	Research Site	Stanford	California
United States	Research Site	Stockton	California
United States	Research Site	Stony Brook	New York
United States	Research Site	Tabor City	North Carolina
United States	Research Site	Tampa	Florida
United States	Research Site	Tomball	Texas
United States	Research Site	Torrance	California
* Note: There are 1034 locations in all - only the first 1000 are shown.

Sponsors (1)

Lead Sponsor	Collaborator
Cytokinetics

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sørensen T, Böhm 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Cardiovascular Death or First Heart Failure Event	The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis.; A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy.; All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials.; Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.	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	Time to Cardiovascular Death	Cardiovascular death includes acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.; All deaths were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.; Time to cardiovascular death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.	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	Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24	The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire with a 2-week recall period that includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where lower scores represent more frequent and severe symptoms and scores of 100 indicate no symptoms.; The change from baseline in KCCQ TSS was analyzed separately for each randomization setting (inpatient and outpatient).; Least squares means are from the mixed model which includes baseline total symptom score value, region, baseline eGFR, scheduled visit, treatment group and interaction of treatment with scheduled visit as covariates.	Baseline and Week 24
Secondary	Time to First Heart Failure Hospitalization	A HF hospitalization is defined as an event that met all of the following criteria: The participant was admitted to the hospital with a primary diagnosis of HF; The length of stay in the hospital extended for at least 24 hours; The participant exhibited documented new or worsening symptoms due to HF on presentation; The participant had objective evidence of new or worsening HF; The participant received initiation or intensification of treatment specifically for HF, including an intravenous diuretic or vasoactive agent, mechanical or surgical intervention, or mechanical fluid removal.; Events were adjudicated by an independent external CEC at the Duke Clinical Research Institute using standardized definitions based on the ACC/AHA standards for endpoint definitions in CV clinical trials.; Time to first HF hospitalization was analyzed using KM methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event is reported.	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	Time to All-cause Death	All events were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.; Time to all-cause death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with an event are reported. Events that occurred up to the earliest of last confirmed survival status date or analysis cut-off date (07 August 2020) are included.	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.

External Links

•   AmgenTrials clinical trials website