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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)

This study has been completed.
Sponsor:
Collaborator:
Cytokinetics
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01300013
First received: February 17, 2011
Last updated: March 24, 2014
Last verified: March 2014

February 17, 2011
March 24, 2014
April 2011
April 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01300013 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • To characterize pharmacokinetics of omecamtiv mecarbil, including metabolites M1 and M3, following IV infusion and to evaluate the relationship between omecamtiv mecarbil plasma concentration and echocardiographic parameters in subjects with AHF [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 days alive out of hospital up to Day 30 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Drug: Placebo
    48-hour infusion of placebo
  • Drug: Omecamtiv mecarbil
    48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
    Other Names:
    • CK-1827452
    • AMG 423
  • Experimental: Omecamtiv mecarbil
    Intervention: Drug: Omecamtiv mecarbil
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
614
September 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Bulgaria,   Canada,   Czech Republic,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Lithuania,   Netherlands,   Norway,   Poland,   Russian Federation,   Slovakia,   United Kingdom
 
NCT01300013
20100754
Yes
Amgen
Amgen
Cytokinetics
Study Director: MD Amgen
Amgen
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP