A Study of Short-Term Outcomes and Economic Impact For Patients With Worsening Congestive Heart Failure When Natrecor (Nesiritide) is Added to Standard-Care Therapy, Compared to Administration of Placebo With Standard-Care Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Scios, Inc.
ClinicalTrials.gov Identifier:
NCT00270387
First received: December 22, 2005
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

The purpose of this pilot study is to compare the clinical effects, safety profile, and economic impact of standard therapy plus Natrecor® (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to standard therapy plus placebo in patients who present to the Emergency Department with worsening congestive heart failure (CHF) and are treated in the Emergency Department /Observation Unit.


Condition Intervention Phase
Cardiomyopathies
Heart Failure, Congestive
Dyspnea, Paroxysma
Drug: Natrecor (nesiritide)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Prospective Randomized Outcomes Study of Acutely Decompensated Congestive Heart Failure Treated Initially in Outpatients With Natrecor (Nesiritide) - The PROACTION Trial

Resource links provided by NLM:


Further study details as provided by Scios, Inc.:

Primary Outcome Measures:
  • Natrecor® can be safely administered in outpatient settings with blood pressure monitoring; Number of hospital readmissions and average length of stay in the hospital

Secondary Outcome Measures:
  • Economic Impact on hospitals of earlier and more aggressive treatment in the Emergency Department with Natrecor® added to standard care

Enrollment: 250
Study Start Date: January 2001
Study Completion Date: January 2002
Arms Assigned Interventions
Experimental: 001
Natrecor (nesiritide)
Drug: Natrecor (nesiritide)

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Patients with a history consistent with congestive heart failure (either chronic or new onset) with fluid overload or elevated cardiac filling pressures by clinical diagnosis
  • having a need for observation and intravenous therapy for at least 12 hours, primarily for the treatment of acutely worsening heart failure
  • having dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal exertion, and evidence of heart failure rather than pulmonary disease as the primary cause for the dyspnea
  • having jugular venous distension, abdominal discomfort (such as decreased appetite or nausea) and a weight gain of at least 5 pounds in the previous month
  • having chest x-ray findings indicative of heart failure, or rales (sounds associated with fluid in the lung cavity) heard on physical examination.

Exclusion Criteria:

  • Patients having a clinical status so acutely unstable that invasive monitoring or mechanical ventilation is required
  • admitted to Emergency Department/Observation Unit primarily for a diagnostic evaluation (such as ruling out myocardial infarction or to diagnose irregular heart beats)
  • having systolic blood pressure consistently less than 90 mm Hg
  • having cardiogenic shock (a sudden decrease in blood pressure that results in decreased perfusion of body tissues and organs), volume depletion, or any other clinical condition that would contraindicate the administration of intravenous diuretics, ACE inhibitors, or an intravenous agent with potent vasodilating properties
  • having a circumstance recognized at baseline evaluation that would definitely prohibit discharge to home from the Emergency Department/Observation Unit in less than 24 hours.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00270387

Sponsors and Collaborators
Scios, Inc.
Investigators
Study Director: Scios, Inc. Clinical Trial Scios, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Scios, Inc.
ClinicalTrials.gov Identifier: NCT00270387     History of Changes
Other Study ID Numbers: CR005209
Study First Received: December 22, 2005
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Scios, Inc.:
Acutely Decompensated Congestive Heart Failure
Heart Failure
Renal Impairment
Kidney Failure
Myocardial Infarction.

Additional relevant MeSH terms:
Dyspnea
Heart Failure
Cardiomyopathies
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014