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NCT01300013 Clinical 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)

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01300013
Other study ID # 20100754
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2011
Est. completion date September 2013

Study information
Verified date July 2021
Source Cytokinetics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 614
Est. completion date September 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
48-hour infusion of placebo
• Omecamtiv mecarbil
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.

Locations
Country Name City State
Australia Research Site Bedford Park South Australia
Australia Research Site Darlinghurst New South Wales
Australia Research Site Prahran Victoria
Australia Research Site Richmond Victoria
Australia Research Site Woolloongabba Queensland
Belgium Research Site Aalst
Belgium Research Site Bonheiden
Belgium Research Site Gent
Belgium Research Site Roeselare
Bulgaria Research Site Blagoevgrad
Bulgaria Research Site Kazanlak
Bulgaria Research Site Pazardzhik
Bulgaria Research Site Plovdiv
Bulgaria Research Site Sandanski
Bulgaria Research Site Smolyan
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Canada Research Site Calgary Alberta
Canada Research Site Edmonton Alberta
Canada Research Site Edmonton Alberta
Canada Research Site Halifax Nova Scotia
Canada Research Site Montreal Quebec
Canada Research Site Ottawa Ontario
Canada Research Site Québec Quebec
Canada Research Site Sherbrooke Quebec
Canada Research Site Toronto Ontario
Canada Research Site Toronto Ontario
Czechia Research Site Brno
Czechia Research Site Brno
Czechia Research Site Praha 2
Czechia Research Site Praha 5
Czechia Research Site Usti nad Labem
Finland Research Site Helsinki
Finland Research Site Turku
France Research Site Caen Cedex 9
France Research Site Lille Cedex
France Research Site Montpellier cedex 05
France Research Site Paris
France Research Site Paris Cedex 13
France Research Site Strasbourg
France Research Site Toulouse Cedex 09
Germany Research Site Bad Nauheim
Germany Research Site Dortmund
Germany Research Site Dresden
Germany Research Site Frankfurt
Germany Research Site Frankfurt
Germany Research Site Greifswald
Germany Research Site Halle/Saale
Germany Research Site Hamburg
Germany Research Site Homburg
Germany Research Site Langen
Germany Research Site Regensburg
Germany Research Site Stuttgart
Germany Research Site Würzburg
Greece Research Site Athens
Greece Research Site Athens
Greece Research Site Haidari
Greece Research Site Heraklion
Greece Research Site Patra
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Budapest
Hungary Research Site Pecs
Hungary Research Site Szolnok
Italy Research Site Brescia
Italy Research Site Cagliari
Italy Research Site Pavia
Italy Research Site Udine
Lithuania Research Site Kaunas
Lithuania Research Site Vilnius
Netherlands Research Site Delft
Netherlands Research Site Deventer
Netherlands Research Site Utrecht
Norway Research Site Oslo
Norway Research Site Stavanger
Poland Research Site Bialystok
Poland Research Site Gdansk
Poland Research Site Krakow
Poland Research Site Krakow
Poland Research Site Lodz
Poland Research Site Lublin
Poland Research Site Wroclaw
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Saint-Petersburg
Russian Federation Research Site St Petersburg
Russian Federation Research Site St. Petersburg
Russian Federation Research Site St.-Petrsburg
Slovakia Research Site Bratislava
Slovakia Research Site Bratislava
Slovakia Research Site Kosice
Slovakia Research Site Nitra
United Kingdom Research Site Bristol
United Kingdom Research Site Cottingham
United Kingdom Research Site Glasgow
United Kingdom Research Site Harrow
United States Research Site Atlanta Georgia
United States Research Site Atlantis Florida
United States Research Site Baltimore Maryland
United States Research Site Bronx New York
United States Research Site Chapel Hill North Carolina
United States Research Site Charleston South Carolina
United States Research Site Charlotte North Carolina
United States Research Site Chicago Illinois
United States Research Site Cincinnati Ohio
United States Research Site Cincinnati Ohio
United States Research Site Cincinnati Ohio
United States Research Site Clearwater Florida
United States Research Site Cleveland Ohio
United States Research Site Columbus Ohio
United States Research Site Cortlandt Manor New York
United States Research Site Danbury Connecticut
United States Research Site Detroit Michigan
United States Research Site Detroit Michigan
United States Research Site Durham North Carolina
United States Research Site Fairfield Ohio
United States Research Site Fort Lauderdale Florida
United States Research Site Greenville South Carolina
United States Research Site Houston Texas
United States Research Site Inglewood California
United States Research Site La Jolla California
United States Research Site Lincoln Nebraska
United States Research Site Memphis Tennessee
United States Research Site Miami Florida
United States Research Site Minneapolis Minnesota
United States Research Site Mobile Alabama
United States Research Site Murray Utah
United States Research Site Nashville Tennessee
United States Research Site Nashville Tennessee
United States Research Site Newark Delaware
United States Research Site Newark New Jersey
United States Research Site Novi Michigan
United States Research Site Oklahoma City Oklahoma
United States Research Site Orlando Florida
United States Research Site Peoria Illinois
United States Research Site Portland Oregon
United States Research Site Roslyn New York
United States Research Site Saint Louis Missouri
United States Research Site San Francisco California
United States Research Site Tullahoma Tennessee
United States Research Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Cytokinetics

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Czechia,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Lithuania,  Netherlands,  Norway,  Poland,  Russian Federation,  Slovakia,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 48 hours
Secondary 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 48 hours
Secondary 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 48 hours
Secondary 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 48 hours
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External Links