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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01300013




Registration number
NCT01300013
Ethics application status
Date submitted
17/02/2011
Date registered
21/02/2011
Date last updated
27/07/2021

Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)
Scientific title
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure
Secondary ID [1] 0 0
20100754
Universal Trial Number (UTN)
Trial acronym
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
Cardiovascular 0 0 0 0
Other cardiovascular diseases

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

Experimental: Omecamtiv mecarbil -

Placebo Comparator: Placebo -


Treatment: Drugs: Placebo
48-hour infusion of placebo

Treatment: Drugs: Omecamtiv mecarbil
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure.
Timepoint [1] 0 0
48 hours
Secondary outcome [1] 0 0
To characterize pharmacokinetics of omecamtiv mecarbil including metabolites following IV infusion and to evaluate the relationship between omecamtiv mecarbil plasma concentration and echocardiographic parameters in subjects with AHF
Timepoint [1] 0 0
48 hours
Secondary outcome [2] 0 0
To assess the safety and tolerability of 3 dose levels of IV omecamtiv mecarbil compared with placebo in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure
Timepoint [2] 0 0
48 hours
Secondary outcome [3] 0 0
To evaluate the effects of 48 hours treatment with IV omecamtiv mecarbil on additional measures of dyspnea, patient global assessment (PGA), change in NT-proBNP, incidence of worsening heart failure, and short term clinical outcomes
Timepoint [3] 0 0
48 hours

Eligibility
Key inclusion criteria
- Male or female 18 - 85 years

- Hospitalized for worsening heart failure, within 24 hours of initiating IV loop
diuretic

- Dyspnea due to heart failure, at rest or with minimal exertion

- History of left ventricular ejection fraction (LVEF) = 40%

- Elevated brain natriuretic peptide (BNP) or N-terminal fragment BNP (NT-proBNP)
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Receiving IV vasopressor (excluding low dopamine), inotropic or mechanical support

- Acute coronary syndrome (ACS)

- Within 30 days prior to enrollment: cardiac resynchronization therapy (CRT) or
implantable cardioverter defibrillator (ICD) implantation, ACS, coronary
revascularization, transient ischemic attack (TIA) or stroke, sustained ventricular
arrhythmia, or major surgery

- Severe valvular stenosis, hypertrophic obstructive cardiomyopathy, active myocarditis,
constrictive pericarditis, or clinically significant congenital heart disease

- Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2

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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
614
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Woolloongabba
Recruitment hospital [3] 0 0
Research Site - Bedford Park
Recruitment hospital [4] 0 0
Research Site - Prahran
Recruitment hospital [5] 0 0
Research Site - Richmond
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5042 - Bedford Park
Recruitment postcode(s) [4] 0 0
3181 - Prahran
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Delaware
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Georgia
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Illinois
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Michigan
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Missouri
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New York
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North Carolina
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Ohio
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Oklahoma
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Tennessee
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Texas
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Utah
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Belgium
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Aalst
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Bonheiden
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Gent
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Belgium
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Roeselare
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Blagoevgrad
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Plovdiv
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Sandanski
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Smolyan
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Sofia
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Turku
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Pavia
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Udine
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Vilnius
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Kosice
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Nitra
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Bristol
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Cottingham
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Glasgow
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Harrow

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV)
omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular
systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized,
double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of
ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to
omecamtiv mecarbil or placebo.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01300013
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01300013