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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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ClinicalTrials.gov Identifier: NCT01300013
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : April 21, 2014
Sponsor:
Collaborator:
Cytokinetics
Information provided by (Responsible Party):
Amgen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Placebo Drug: Omecamtiv mecarbil Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Experimental: Omecamtiv mecarbil Drug: Omecamtiv mecarbil
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Other Names:
  • CK-1827452
  • AMG 423
Placebo Comparator: Placebo Drug: Placebo
48-hour infusion of placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300013


Locations
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Sponsors and Collaborators
Amgen
Cytokinetics
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01300013    
Other Study ID Numbers: 20100754
First Posted: February 21, 2011    Key Record Dates
Last Update Posted: April 21, 2014
Last Verified: March 2014
Keywords provided by Amgen:
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
Additional relevant MeSH terms:
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Heart Failure
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction