Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Management of Patients With Congestive Heart Failure After Hospitalization
This study is ongoing, but not recruiting participants.
Sponsored by: Scios, Inc.
Information provided by: Scios, Inc.
ClinicalTrials.gov Identifier: NCT00040612
  Purpose

The objective of this study is to assess the safety and tolerability of different doses of Natrecor® when administered serially to patients with decompensated CHF who are concomitantly receiving their usual cardiac medications and are at high risk for hospitalization.


Condition Intervention Phase
Heart Failure, Congestive
Drug: nesiritide
Phase IV

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in the study

  • Age _ 18 years.
  • At least two hospital admissions or equivalent treatment (e.g., Emergency Department/observation unit admissions or unscheduled clinic visits) with IV vasoactive agents (such as IV inotropes, Natrecor®, or nitroglycerin for acutely decompensated CHF) within the last 12 months, with at least one of these admissions in the past 30 days. (Note: Infusions of diuretics in an outpatient setting should not be counted as a treatment to satisfy this inclusion criteria. The major reason for a hospital admission should be for the treatment of acutely decompensated CHF).
  • Able to be enrolled and initiate treatment with study drug within 5–30 days of last hospital discharge or equivalent treatment of acutely decompensated CHF.
  • Baseline NYHA Functional Classification III/IV for at least 2 months prior to randomization (see Appendix 4).
  • Receiving optimal treatment with long term oral medications (e.g., diuretics, ACE inhibitors, and beta blockers, unless beta blockers or ACE inhibitors are documented to be contraindicated or not tolerated).
  • Ambulatory and able to participate in the 6-minute walk test.
  • Result of 6-minute walk test is < 400 meters.
  • Have available transportation and are able to attend clinic visits at least once weekly for 12 weeks.
  • Agree to come in to the clinic at least one time each week for 13 weeks and to be available for follow up for three additional weeks.
  • Agree to receive infusions of Natrecor®, or possibly other medications, at least as frequently as once per week for 12 weeks.
  • Females of childbearing potential must be willing to use two forms of contraception.
  • Understood, and signed a written Informed Consent Form before initiation of protocol specified procedures.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not eligible for participation in the study

  • Systolic blood pressure consistently less than 90 mm Hg.
  • Have had or during the course of the study are anticipated to have any organ transplantation (heart, liver, lung, and kidney).
  • Unable or unwilling to discontinue intermittent or continuous infusions of inotropes if randomized to a Natrecor® treatment group.
  • Have had a bi-ventricular pacemaker placed within past 60 days or an automatic implantable cardiac defibrillator (AICD) placed within the past 30 days.
  • Have left ventricular assist device in place (LVAD).
  • Cardiogenic shock, volume depletion, or any other clinical condition that would contraindicate the administration of Natrecor®.
  • Currently receiving chronic dialysis or the expectation that dialysis will be required during the course of the study.
  • Possible allergic reaction or sensitivity to Natrecor®.
  • Females of child bearing potential with a positive pregnancy test, pregnant or nursing mothers, or suspected pregnancy.
  • Medical condition so severe that survival for the treatment and follow-up periods is not likely.
  • Medical condition immediately prior to randomization is such that hospitalization is needed or probably imminent.
  • Concurrent therapy with another investigational drug or device without prior approval from Scios.
  • Unwillingness or inability to comply with study requirements including informed consent, weekly clinic visits, and the follow-up period.
  • Evidence of acute myocardial infarction within the past 30 days.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040612

  Show 54 Study Locations
Sponsors and Collaborators
Scios, Inc.
  More Information

Study ID Numbers: 704.348
Study First Received: July 2, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00040612  
Health Authority: United States: Food and Drug Administration

Keywords provided by Scios, Inc.:
Acute Decompensated CHF
FUSION
Outpatient
Congestive Heart Failure

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009