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Study Complete
Sponsor ID
20100754

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)

Sponsor ID
20100754
Clinicaltrials.gov ID
NCT01300013
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 423
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
614
Additional Study Details

Protocol Summary

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.

Timeframe: 48 hours

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

Timeframe: 48 hours

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

Timeframe: 48 hours

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

Timeframe: 48 hours

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Prahran, VIC, Australia, 3181
Status
Completed
Location
Research Site
Darlinghurst, NSW, Australia, 2010
Status
Recruiting
Location
Research Site
Bedford Park, SA, Australia, 5042
Status
Completed
Location
Research Site
Richmond, VIC, Australia, 3121
Status
Recruiting
Location
Research Site
Aalst, Belgium, 9300
Status
Recruiting
Location
Research Site
Roeselare, Belgium, 8800
Status
Recruiting
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Study Info
Age
18 - 85 Years
Condition
  • Heart Failure
    • Sex
    All
    Trial Dates
    May 2011 - Apr 2013
    Inclusion and Exclusion 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