Trial record 1 of 6 for:    omecamtiv
Previous Study | Return to List | Next Study

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)

This study has been completed.
Sponsor:
Collaborator:
Cytokinetics
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01300013
First received: February 17, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: Placebo
Drug: Omecamtiv mecarbil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

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. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 614
Study Start Date: April 2011
Study Completion Date: September 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omecamtiv mecarbil Drug: Omecamtiv mecarbil
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Other Names:
  • CK-1827452
  • AMG 423
Placebo Comparator: Placebo Drug: Placebo
48-hour infusion of placebo

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300013

  Hide Study Locations
Locations
United States, Alabama
Research Site
Moblie, Alabama, United States, 36608
United States, California
Research Site
Inglewood, California, United States, 90301
Research Site
La Jolla, California, United States, 92037
Research Site
San Francisco, California, United States, 94121
United States, Connecticut
Research Site
Danbury, Connecticut, United States, 06810
United States, Delaware
Research Site
Newark, Delaware, United States, 19718
United States, Florida
Research Site
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
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, Illinois
Research Site
Chicago, Illinois, United States, 60611
Research Site
Peoria, Illinois, United States, 61636
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21201
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
Research Site
Detroit, Michigan, United States, 48202
Research Site
Novi, Michigan, United States, 48374
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55417
United States, Missouri
Research Site
St Louis, Missouri, United States, 63110
United States, Nebraska
Research Site
Lincoln, Nebraska, United States, 68506
United States, New Jersey
Research Site
Newark, New Jersey, United States, 07103
United States, New York
Research Site
Bronx, New York, United States, 10467
Research Site
Cortlandt Manor, New York, United States, 10567
Research Site
Roslyn, New York, United States, 11576
United States, North Carolina
Research Site
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
United States, Ohio
Research Site
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
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29425
Research Site
Greenville, South Carolina, United States, 29605
United States, Tennessee
Research Site
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
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Utah
Research Site
Murray, Utah, United States, 84107
Australia, New South Wales
Research Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Research Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Research Site
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Research Site
Prahran, Victoria, Australia, 3181
Research Site
Richmond, Victoria, Australia, 3121
Belgium
Research Site
Aalst, Belgium, 9300
Research Site
Bonheiden, Belgium, 2820
Research Site
Gent, Belgium, 9000
Research Site
Roeselare, Belgium, 8800
Bulgaria
Research Site
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, 1527
Research Site
Sofia, Bulgaria, 1431
Research Site
Sofia, Bulgaria, 1309
Canada, Alberta
Research Site
Calgary, Alberta, Canada, T2N 4Z6
Research Site
Edmonton, Alberta, Canada, T6G 2B7
Research Site
Edmonton, Alberta, Canada, T6L 5X8
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Research Site
Ottawa, Ontario, Canada, K1Y 4W7
Research Site
Toronto, Ontario, Canada, M5B 1W8
Research Site
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Research Site
Montreal, Quebec, Canada, H3G 1A4
Research Site
Québec, Quebec, Canada, G1V 4G5
Research Site
Sherbrooke, Quebec, Canada, J1H 5N4
Czech Republic
Research Site
Brno, Czech Republic, 656 91
Research Site
Brno, Czech Republic, 625 00
Research Site
Praha 2, Czech Republic, 128 08
Research Site
Praha 5, Czech Republic, 150 06
Research Site
Usti nad Labem, Czech Republic, 401 13
Finland
Research Site
Helsinki, Finland, 00029
Research Site
Turku, Finland, 20521
France
Research Site
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
Germany
Research Site
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
Greece
Research Site
Athens, Greece, 11528
Research Site
Athens, Greece, 16673
Research Site
Haidari, Greece, 12462
Research Site
Heraklion, Greece, 71110
Research Site
Patra, Greece, 26500
Hungary
Research Site
Budapest, Hungary, 1125
Research Site
Budapest, Hungary, 1134
Research Site
Budapest, Hungary, 1122
Research Site
Budapest, Hungary, 1023
Research Site
Pecs, Hungary, 7624
Research Site
Szolnok, Hungary, 5004
Italy
Research Site
Brescia, Italy, 25125
Research Site
Cagliari, Italy, 09134
Research Site
Pavia, Italy, 27100
Research Site
Udine, Italy, 33100
Lithuania
Research Site
Kaunas, Lithuania, 50009
Research Site
Vilnius, Lithuania, 08661
Netherlands
Research Site
Delft, Netherlands, 2625 AD
Research Site
Deventer, Netherlands, 7416 SE
Research Site
Utrecht, Netherlands, 3584 CX
Norway
Research Site
Oslo, Norway, 0424
Research Site
Stavanger, Norway, 4011
Poland
Research Site
Bialystok, Poland, 15-276
Research Site
Gdansk, Poland, 80-952
Research Site
Krakow, Poland, 31-202
Research Site
Krakow, Poland, 31-501
Research Site
Lodz, Poland, 91-347
Research Site
Lublin, Poland, 20-954
Research Site
Wroclaw, Poland, 50-981
Russian Federation
Research Site
Moscow, Russian Federation, 127299
Research Site
Moscow, Russian Federation, 111539
Research Site
Moscow, Russian Federation, 119991
Research Site
Moscow, Russian Federation, 127473
Research Site
Moscow, Russian Federation, 109240
Research Site
Moscow, Russian Federation, 117292
Research Site
Moscow, Russian Federation, 115093
Research Site
Moscow, Russian Federation, 119620
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
Slovakia
Research Site
Bratislava, Slovakia, 826 06
Research Site
Bratislava, Slovakia, 851 07
Research Site
Kosice, Slovakia, 040 66
Research Site
Nitra, Slovakia, 949 01
United Kingdom
Research Site
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
Sponsors and Collaborators
Amgen
Cytokinetics
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01300013     History of Changes
Other Study ID Numbers: 20100754
Study First Received: February 17, 2011
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Amgen:
Omecamtiv mecarbil
Intravenous
IV
Left Ventricular Systolic Dysfunction
Hospitalized
Acute heart failure
Heart failure
Left ventricular ejection fraction
pharmacokinetics
Pharmacodynamics
Dyspnea
hospitalization
In-patient
Double-blind
Randomized
Placebo-controlled

Additional relevant MeSH terms:
Heart Failure
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction

ClinicalTrials.gov processed this record on July 26, 2014