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Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259038
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:
The study will evaluate the safety and efficacy of intravenous infusion of carperitide using pressure measurements inside the heart and great vessels and measuring carperitide concentration in the blood.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Heart Decompensation Left Ventricular Failure Myocardiopathies Systolic or Diastolic Left Ventricular Dysfunction Drug: Carperitide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure
Study Start Date : January 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Experimental Drug Drug: Carperitide
Other Name: human recombinant atrial natriuretic peptide

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in pulmonary capillary wedge pressure (PCWP) [ Time Frame: at 3 hours following initiation of study drug infusion ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Is hospitalized with congestive heart failure (CHF)
  • Has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mmHg or higher

Exclusion Criteria:

  • Has had a heart transplant
  • Requires mechanical ventilation or mechanical circulatory support

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259038

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United States, Alabama
Huntsville, Alabama, United States, 35801
United States, California
Los Angeles, California, United States, 90033
Orange, California, United States, 92868
San Diego, California, United States, 92103
United States, Florida
Bay Pines, Florida, United States, 33744
Gainesville, Florida, United States, 32610
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33136
Orlando, Florida, United States, 32803
St Petersburg, Florida, United States, 33707
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612
Springfield, Illinois, United States, 62701
United States, Louisiana
Covington, Louisiana, United States, 70433
Shreveport, Louisiana, United States, 71103
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St Louis, Missouri, United States, 63110
United States, New York
Albany, New York, United States
United States, Ohio
Cincinnati, Ohio, United States, 45267
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, South Carolina
Charleston, South Carolina, United States
Columbia, South Carolina, United States
United States, Texas
Amarillo, Texas, United States, 79106
Houston, Texas, United States, 77030
Houston, Texas, United States, 77225
United States, Virginia
Richmond, Virginia, United States, 23298
United States, Washington
Tacoma, Washington, United States, 98405
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
Montreal, Quebec, Canada
St Foy, Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Daiichi Sankyo, Inc.
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Study Director: Biljana Pavlovic-Surjancev, MD, PhD Astellas Pharma US, Inc.

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Responsible Party: Daiichi Sankyo, Inc. Identifier: NCT00259038    
Other Study ID Numbers: 03-0-162
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Keywords provided by Daiichi Sankyo, Inc.:
Atrial Natriuretic Peptide
Treatment efficacy
Heart failure, Congestive
Pulmonary Artery Catheterization
Additional relevant MeSH terms:
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Heart Failure
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases