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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02929329




Registration number
NCT02929329
Ethics application status
Date submitted
30/09/2016
Date registered
11/10/2016
Date last updated
5/11/2021

Titles & IDs
Public title
Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction
Scientific 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)
Secondary ID [1] 0 0
2016-002299-28
Secondary ID [2] 0 0
20110203
Universal Trial Number (UTN)
Trial acronym
GALACTIC-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Omecamtiv Mecarbil
Treatment: Drugs - Placebo
Treatment: Drugs - Standard of Care

Experimental: Omecamtiv Mecarbil - Participants received oral omecamtiv mecarbil (OM) twice daily in addition to standard heart failure therapy. The starting dose of OM was 25 mg; At week 4, participants with week 2 OM predose plasma concentrations \< 200 ng/mL had their dose increased to 50 mg BID; participants with week 2 predose plasma concentrations = 200 and \< 300 ng/mL had their dose increased to 37.5 mg BID and participants with week 2 predose plasma concentrations = 300 ng/mL and \< 1000 ng/mL maintained a 25 mg BID dosing regimen.

Placebo comparator: Placebo - Participants received matching placebo tablets twice a day in addition to standard heart failure therapy.


Treatment: Drugs: Omecamtiv Mecarbil
Omecamtiv mecarbil tablets for oral administration

Treatment: Drugs: Placebo
Matching placebo tablets

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Cardiovascular Death or First Heart Failure Event
Timepoint [1] 0 0
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 outcome [1] 0 0
Time to Cardiovascular Death
Timepoint [1] 0 0
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 outcome [2] 0 0
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Time to First Heart Failure Hospitalization
Timepoint [3] 0 0
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 outcome [4] 0 0
Time to All-cause Death
Timepoint [4] 0 0
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.

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/09/2020
Sample size
Target
Accrual to date
Final
8256
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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2605 - Garran
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2139 - Concord
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2010 - Darlinghurst
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2170 - Liverpool
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2305 - New Lambton Heights
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4032 - Chermside
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4029 - Herston
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4102 - Woolloongabba
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5035 - Ashford
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5042 - Bedford Park
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5063 - Fullarton
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5011 - Woodville South
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3083 - Bundoora
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3199 - Frankston
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3220 - Geelong
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3121 - Richmond
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6150 - Murdoch
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Italy
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Saga
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Kharkiv
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United Kingdom
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Dudley
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United Kingdom
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Dundee
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United Kingdom
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Exeter
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United Kingdom
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Gillingham
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United Kingdom
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Glasgow
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Harlow
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London
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Newport
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Northwood
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Peterborough
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Shipley
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Stevenage
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United Kingdom
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Sunderland
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United Kingdom
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Swindon
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United Kingdom
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Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cytokinetics
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT02929329
Trial related presentations / publications
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.
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. Erratum In: Eur Heart J. 2022 Aug 7;43(30):2903. doi: 10.1093/eurheartj/ehac332.
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.
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.
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.
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02929329