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.
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)
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Failure
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
* 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
Inclusion 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)
* 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)
Gender
All
Gender Based
false
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
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
18 Years
NCT Id
NCT01300013
Org Class
Industry
Org Full Name
Cytokinetics
Org Study Id
20100754
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
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.
Outcome Time Frame
48 hours
Secondary Outcomes
Outcome Time Frame
48 hours
Outcome Measure
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
Outcome Time Frame
48 hours
Outcome Measure
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
Outcome Time Frame
48 hours
Outcome Measure
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
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jooyoung Shin
Investigator Email
jushin@montefiore.org
Investigator Phone