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)

July 25, 2021 updated by: Cytokinetics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
614

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Research Site
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Research Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Research Site
    • Victoria
      • Prahran, Victoria, Australia, 3181
        • Research Site
      • Richmond, Victoria, Australia, 3121
        • Research Site
  • Belgium
      • Aalst, Belgium, 9300
        • Research Site
      • Bonheiden, Belgium, 2820
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Research Site
      • Kazanlak, Bulgaria, 6100
        • Research Site
      • Pazardzhik, Bulgaria, 4700
        • Research Site
      • Plovdiv, Bulgaria, 4002
        • Research Site
      • Sandanski, Bulgaria, 2800
        • Research Site
      • Smolyan, Bulgaria, 4400
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1527
        • Research Site
      • Sofia, Bulgaria, 1309
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Research Site
      • Edmonton, Alberta, Canada, T6L 5X8
        • Research Site
      • Edmonton, Alberta, Canada, T6G 2B7
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Research Site
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Research Site
      • Toronto, Ontario, Canada, M5G 1X5
        • Research Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Research Site
      • Québec, Quebec, Canada, G1V 4G5
        • Research Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Research Site
  • Czechia
      • Brno, Czechia, 625 00
        • Research Site
      • Brno, Czechia, 656 91
        • Research Site
      • Praha 2, Czechia, 128 08
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
      • Usti nad Labem, Czechia, 401 13
        • Research Site
  • Finland
      • Helsinki, Finland, 00029
        • Research Site
      • Turku, Finland, 20521
        • Research Site
  • France
      • Caen Cedex 9, France, 14033
        • Research Site
      • Lille Cedex, France, 59037
        • Research Site
      • Montpellier cedex 05, France, 34295
        • Research Site
      • Paris, France, 75010
        • Research Site
      • Paris Cedex 13, France, 75651
        • Research Site
      • Strasbourg, France, 67091
        • Research Site
      • Toulouse Cedex 09, France, 31403
        • Research Site
  • Germany
      • Bad Nauheim, Germany, 61231
        • Research Site
      • Dortmund, Germany, 44137
        • Research Site
      • Dresden, Germany, 01307
        • Research Site
      • Frankfurt, Germany, 60488
        • Research Site
      • Frankfurt, Germany, 60590
        • Research Site
      • Greifswald, Germany, 17475
        • Research Site
      • Halle/Saale, Germany, 06097
        • Research Site
      • Hamburg, Germany, 20246
        • Research Site
      • Homburg, Germany, 66421
        • Research Site
      • Langen, Germany, 63225
        • Research Site
      • Regensburg, Germany, 93053
        • Research Site
      • Stuttgart, Germany, 70376
        • Research Site
      • Würzburg, Germany, 97080
        • Research Site
  • Greece
      • Athens, Greece, 11528
        • Research Site
      • Athens, Greece, 16673
        • Research Site
      • Haidari, Greece, 12462
        • Research Site
      • Heraklion, Greece, 71110
        • Research Site
      • Patra, Greece, 26500
        • Research Site
  • Hungary
      • Budapest, Hungary, 1125
        • Research Site
      • Budapest, Hungary, 1122
        • Research Site
      • Budapest, Hungary, 1134
        • Research Site
      • Budapest, Hungary, 1023
        • Research Site
      • Pecs, Hungary, 7624
        • Research Site
      • Szolnok, Hungary, 5004
        • Research Site
  • Italy
      • Brescia, Italy, 25125
        • Research Site
      • Cagliari, Italy, 09134
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Udine, Italy, 33100
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Research Site
      • Vilnius, Lithuania, 08661
        • Research Site
  • Netherlands
      • Delft, Netherlands, 2625 AD
        • Research Site
      • Deventer, Netherlands, 7416 SE
        • Research Site
      • Utrecht, Netherlands, 3584 CX
        • Research Site
  • Norway
      • Oslo, Norway, 0424
        • Research Site
      • Stavanger, Norway, 4011
        • Research Site
  • Poland
      • Bialystok, Poland, 15-276
        • Research Site
      • Gdansk, Poland, 80-952
        • Research Site
      • Krakow, Poland, 31-501
        • Research Site
      • Krakow, Poland, 31-202
        • Research Site
      • Lodz, Poland, 91-347
        • Research Site
      • Lublin, Poland, 20-954
        • Research Site
      • Wroclaw, Poland, 50-981
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation, 115093
        • Research Site
      • Moscow, Russian Federation, 119991
        • Research Site
      • Moscow, Russian Federation, 127473
        • Research Site
      • Moscow, Russian Federation, 109240
        • Research Site
      • Moscow, Russian Federation, 111539
        • Research Site
      • Moscow, Russian Federation, 117292
        • Research Site
      • Moscow, Russian Federation, 119620
        • Research Site
      • Moscow, Russian Federation, 127299
        • Research Site
      • Saint Petersburg, Russian Federation, 197341
        • Research Site
      • Saint-Petersburg, Russian Federation, 195067
        • Research Site
      • St Petersburg, Russian Federation, 198205
        • Research Site
      • St. Petersburg, Russian Federation, 199106
        • Research Site
      • St.-Petrsburg, Russian Federation, 196247
        • Research Site
  • Slovakia
      • Bratislava, Slovakia, 851 07
        • Research Site
      • Bratislava, Slovakia, 826 06
        • Research Site
      • Kosice, Slovakia, 040 66
        • Research Site
      • Nitra, Slovakia, 949 01
        • Research Site
  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • Research Site
      • Cottingham, United Kingdom, HU16 5JQ
        • Research Site
      • Glasgow, United Kingdom, G11 6NT
        • Research Site
      • Harrow, United Kingdom, HA1 3UJ
        • Research Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Research Site
    • California
      • Inglewood, California, United States, 90301
        • Research Site
      • La Jolla, California, United States, 92037
        • Research Site
      • San Francisco, California, United States, 94121
        • Research Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Research Site
    • Delaware
      • Newark, Delaware, United States, 19718
        • Research Site
    • Florida
      • Atlantis, Florida, United States, 33462
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Research Site
      • Fort Lauderdale, Florida, United States, 33308
        • Research Site
      • Miami, Florida, United States, 33133
        • Research Site
      • Orlando, Florida, United States, 32803
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Research Site
      • Peoria, Illinois, United States, 61636
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Research Site
      • Detroit, Michigan, United States, 48201
        • Research Site
      • Novi, Michigan, United States, 48374
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Research Site
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Research Site
    • New York
      • Bronx, New York, United States, 10467
        • Research Site
      • Cortlandt Manor, New York, United States, 10567
        • Research Site
      • Roslyn, New York, United States, 11576
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Research Site
      • Charlotte, North Carolina, United States, 28204
        • Research Site
      • Durham, North Carolina, United States, 27705
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45267
        • Research Site
      • Cincinnati, Ohio, United States, 45220
        • Research Site
      • Cleveland, Ohio, United States, 44109
        • Research Site
      • Columbus, Ohio, United States, 43210
        • Research Site
      • Fairfield, Ohio, United States, 45014
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Research Site
      • Greenville, South Carolina, United States, 29605
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
      • Nashville, Tennessee, United States, 37232-8802
        • Research Site
      • Tullahoma, Tennessee, United States, 37388
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site
    • Utah
      • Murray, Utah, United States, 84107
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
48-hour infusion of placebo
Experimental: Omecamtiv mecarbil
Drug: Omecamtiv mecarbil
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Other Names:
  • AMG 423
  • CK-1827452

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
48 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
Time Frame: 48 hours
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
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cytokinetics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20100754

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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