Back to resultsStudy 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)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Omecamtiv mecarbil
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Intravenous, IV, Left Ventricular Systolic Dysfunction, Hospitalized, Acute heart failure, Heart failure, Left ventricular ejection fraction, pharmacokinetics, Pharmacodynamics, Dyspnea, hospitalization, In-patient, Omecamtiv mecarbil, Double-blind, Randomized, Placebo-controlled
Eligibility Criteria
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)
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
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omecamtiv mecarbil
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01300013
Brief 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)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokinetics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Intravenous, IV, Left Ventricular Systolic Dysfunction, Hospitalized, Acute heart failure, Heart failure, Left ventricular ejection fraction, pharmacokinetics, Pharmacodynamics, Dyspnea, hospitalization, In-patient, Omecamtiv mecarbil, Double-blind, Randomized, Placebo-controlled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
614 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omecamtiv mecarbil
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
48-hour infusion of placebo
Intervention Type
Drug
Intervention Name(s)
Omecamtiv mecarbil
Other Intervention Name(s)
CK-1827452, AMG 423
Intervention Description
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Primary Outcome Measure Information:
Title
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
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
Time Frame
48 hours
Title
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
Time Frame
48 hours
Title
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
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
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Research Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
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Research Site
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La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
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Research Site
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San Francisco
State/Province
California
ZIP/Postal Code
94121
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United States
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Danbury
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Connecticut
ZIP/Postal Code
06810
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United States
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Newark
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Delaware
ZIP/Postal Code
19718
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United States
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Research Site
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Atlantis
State/Province
Florida
ZIP/Postal Code
33462
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United States
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Research Site
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Clearwater
State/Province
Florida
ZIP/Postal Code
33756
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United States
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Fort Lauderdale
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Florida
ZIP/Postal Code
33308
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United States
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Miami
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Florida
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33133
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United States
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Orlando
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Florida
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32803
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United States
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Atlanta
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Georgia
ZIP/Postal Code
30322
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United States
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Research Site
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Chicago
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Illinois
ZIP/Postal Code
60611
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United States
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Peoria
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Illinois
ZIP/Postal Code
61636
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21201
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United States
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Detroit
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Michigan
ZIP/Postal Code
48201
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United States
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Detroit
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Michigan
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48202
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United States
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Novi
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Michigan
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48374
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United States
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Minneapolis
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Minnesota
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55417
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United States
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Saint Louis
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Missouri
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63110
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United States
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Lincoln
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Nebraska
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68506
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United States
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Newark
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New Jersey
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07103
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United States
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Bronx
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New York
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10467
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United States
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Cortlandt Manor
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New York
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10567
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United States
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Roslyn
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New York
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11576
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United States
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Chapel Hill
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North Carolina
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27599
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United States
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Charlotte
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North Carolina
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28204
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United States
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Durham
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27705
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Winston-Salem
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27103
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Cincinnati
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Ohio
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45219
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United States
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Cincinnati
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Ohio
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45220
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United States
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Cincinnati
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Ohio
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45267
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Cleveland
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43210
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97239
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Charleston
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29425
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Greenville
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South Carolina
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29605
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Memphis
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Tennessee
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38120
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United States
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Nashville
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37203
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Nashville
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37232-8802
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Tullahoma
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37388
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Murray
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5042
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Victoria
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3181
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Richmond
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Victoria
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3121
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Aalst
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9300
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Bonheiden
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2820
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Gent
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9000
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Belgium
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Roeselare
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8800
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Belgium
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Blagoevgrad
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2700
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Bulgaria
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City
Kazanlak
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6100
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Bulgaria
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City
Pazardzhik
ZIP/Postal Code
4700
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Bulgaria
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City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
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City
Sandanski
ZIP/Postal Code
2800
Country
Bulgaria
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City
Smolyan
ZIP/Postal Code
4400
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Bulgaria
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City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
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City
Sofia
ZIP/Postal Code
1431
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Bulgaria
Facility Name
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City
Sofia
ZIP/Postal Code
1527
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Bulgaria
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City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
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Canada
Facility Name
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City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
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City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
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Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
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Canada
Facility Name
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City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
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City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
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City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
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City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
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Canada
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City
Sherbrooke
State/Province
Quebec
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J1H 5N4
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Canada
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City
Brno
ZIP/Postal Code
625 00
Country
Czechia
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City
Brno
ZIP/Postal Code
656 91
Country
Czechia
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City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
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City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
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City
Helsinki
ZIP/Postal Code
00029
Country
Finland
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City
Turku
ZIP/Postal Code
20521
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Finland
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Caen Cedex 9
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14033
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France
Facility Name
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City
Lille Cedex
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59037
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France
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City
Montpellier cedex 05
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34295
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France
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City
Paris Cedex 13
ZIP/Postal Code
75651
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France
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City
Paris
ZIP/Postal Code
75010
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France
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Strasbourg
ZIP/Postal Code
67091
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France
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City
Toulouse Cedex 09
ZIP/Postal Code
31403
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France
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City
Bad Nauheim
ZIP/Postal Code
61231
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Germany
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Dortmund
ZIP/Postal Code
44137
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Germany
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Dresden
ZIP/Postal Code
01307
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Germany
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Frankfurt
ZIP/Postal Code
60488
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Germany
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Frankfurt
ZIP/Postal Code
60590
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Germany
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Greifswald
ZIP/Postal Code
17475
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Germany
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Halle/Saale
ZIP/Postal Code
06097
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Germany
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Hamburg
ZIP/Postal Code
20246
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Germany
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City
Homburg
ZIP/Postal Code
66421
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Germany
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City
Langen
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63225
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Germany
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City
Regensburg
ZIP/Postal Code
93053
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Germany
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Stuttgart
ZIP/Postal Code
70376
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Germany
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Würzburg
ZIP/Postal Code
97080
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Germany
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Athens
ZIP/Postal Code
11528
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Greece
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Athens
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16673
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Greece
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Haidari
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12462
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Greece
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Heraklion
ZIP/Postal Code
71110
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Greece
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Patra
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26500
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Greece
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Budapest
ZIP/Postal Code
1023
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Hungary
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Budapest
ZIP/Postal Code
1122
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Hungary
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Budapest
ZIP/Postal Code
1125
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Hungary
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Budapest
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1134
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Hungary
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Pecs
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7624
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Hungary
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City
Szolnok
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5004
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Hungary
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Brescia
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25125
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Italy
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City
Cagliari
ZIP/Postal Code
09134
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Italy
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City
Pavia
ZIP/Postal Code
27100
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Italy
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City
Udine
ZIP/Postal Code
33100
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Italy
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City
Kaunas
ZIP/Postal Code
50009
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Lithuania
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City
Vilnius
ZIP/Postal Code
08661
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Lithuania
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City
Delft
ZIP/Postal Code
2625 AD
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Netherlands
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Deventer
ZIP/Postal Code
7416 SE
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Netherlands
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Utrecht
ZIP/Postal Code
3584 CX
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Netherlands
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City
Oslo
ZIP/Postal Code
0424
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Norway
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City
Stavanger
ZIP/Postal Code
4011
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Norway
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City
Bialystok
ZIP/Postal Code
15-276
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Poland
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Gdansk
ZIP/Postal Code
80-952
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Poland
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Krakow
ZIP/Postal Code
31-202
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Poland
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City
Krakow
ZIP/Postal Code
31-501
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Poland
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City
Lodz
ZIP/Postal Code
91-347
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Poland
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Lublin
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20-954
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Poland
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Wroclaw
ZIP/Postal Code
50-981
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Poland
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City
Moscow
ZIP/Postal Code
109240
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Russian Federation
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City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117292
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119620
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
127299
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Research Site
City
St Petersburg
ZIP/Postal Code
198205
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Research Site
City
St.-Petrsburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
Research Site
City
Kosice
ZIP/Postal Code
040 66
Country
Slovakia
Facility Name
Research Site
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Research Site
City
Cottingham
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Research Site
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27012405
Citation
Teerlink JR, Felker GM, McMurray JJV, Ponikowski P, Metra M, Filippatos GS, Ezekowitz JA, Dickstein K, Cleland JGF, Kim JB, Lei L, Knusel B, Wolff AA, Malik FI, Wasserman SM; ATOMIC-AHF Investigators. Acute Treatment With Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: The ATOMIC-AHF Study. J Am Coll Cardiol. 2016 Mar 29;67(12):1444-1455. doi: 10.1016/j.jacc.2016.01.031.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
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)
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