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

NCT00270387 | Completed Phase 3

• 1 other identifier: CR005209
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiomyopathies; Heart Failure, Congestive; Dyspnea, Paroxysma

Keywords

Acutely Decompensated Congestive Heart Failure; Heart Failure; Renal Impairment; Kidney Failure; Myocardial Infarction.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

Study Arms (1)

001

EXPERIMENTAL

Natrecor (nesiritide)

Drug: Natrecor (nesiritide)

Interventions

Natrecor (nesiritide) DRUG

001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scios, Inc.: lead

Related Publications (1)

• Peacock WF 4th, Holland R, Gyarmathy R, Dunbar L, Klapholz M, Horton DP, de Lissovoy G, Emerman CL. Observation unit treatment of heart failure with nesiritide: results from the proaction trial. J Emerg Med. 2005 Oct;29(3):243-52. doi: 10.1016/j.jemermed.2005.01.024.

  PMID: 16183441 RESULT

Related Links

• SCIOS Submits Interim Report to FDA

MeSH Terms

Conditions

Cardiomyopathies; Heart Failure; Dyspnea; Renal Insufficiency; Myocardial Infarction

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Scios, Inc. Clinical Trial

  Scios, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: January 1, 2001
• Study Completion: January 1, 2002
• Last Updated: December 13, 2012

Record last verified: 2012-12