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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

614

Phase

  • 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

Ages Eligible for Study

16 years to 83 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
Intervention / Treatment
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

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

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

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

April 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Heart Failure

Clinical Trials on Omecamtiv mecarbil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe