A Study Comparing Blood Flow and Clinical and Safety Effects of the Addition of Natrecor (Nesiritide), Placebo or Intravenous Nitroglycerin to Standard Care for the Treatment of Worsening Congestive Heart Failure.

NCT00270374 | Completed Phase 3

• 1 other identifier: CR005206
• Study Type: interventional
• Target: 498
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to those of intravenous nitroglycerin or placebo, when added to the standard care therapy that is usually administered in the treatment of patients with worsening congestive heart failure.

Conditions

Symptomatic Decompensated Congestive Heart Failure; Congestive Heart Failure in Acute Coronary Syndrome

Keywords

Congestive heart failure; CHF; Left-sided heart failure; Right-sided heart failure; Systolic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 3 hours after the start of study drug in PCWP (pulmonary capillary wedge pressure) in subjects who have right heart catheters; Change from baseline in dyspnea (difficult breathing) 3 hours after the start study drug

Secondary Outcomes (1)

• Effect on PCWP (pulmonary capillary wedge pressure) and dyspnea (difficult breathing) 1 hour after the start of study drug; Onset of effect on PCWP; Effect on PCWP 24 hours after the start of study drug; Overall safety profile

Study Arms (1)

001

EXPERIMENTAL

nesiritide

Drug: nesiritide

Interventions

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 dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal activity such as talking, eating, or bathing
• having evidence of heart disease, rather than pulmonary disease, as the primary cause for the dyspnea (by demonstrating at least two of the following: jugular venous distension, paroxysmal nocturnal dyspnea or 2-pillow orthopnea within 72 hours before the start of study drug, abdominal discomfort due to hepatosplanchnic congestion, chest x-ray with findings indicative of heart failure)
• having elevated cardiac filling pressures either by clinical estimate in non-catheterized patients, or a measured pulmonary capillary wedge pressure (PCWP) \>= 20 mm Hg in catheterized patients
• requiring hospitalization and intravenous therapy for at least 24 hours for the treatment of acutely decompensated heart failure.

You may not qualify if:

• NPatients 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 an intravenous agent with potent vasodilating properties
• having their most recent pulmonary capillary wedge pressure (PCWP) \< 20 mm Hg within 24 hours before randomization
• having a clinical status so acutely unstable that the potential subject could not tolerate placement of a right heart catheter or the 3-hour placebo period
• unable to have intravenous nitroglycerin withheld (e.g., intravenous nitroglycerin for management of an acute coronary syndrome).

Sponsors & Collaborators

• Scios, Inc.: lead

Related Publications (1)

• Publication Committee for the VMAC Investigators (Vasodilatation in the Management of Acute CHF). Intravenous nesiritide vs nitroglycerin for treatment of decompensated congestive heart failure: a randomized controlled trial. JAMA. 2002 Mar 27;287(12):1531-40. doi: 10.1001/jama.287.12.1531.

  PMID: 11911755 RESULT

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

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

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: October 1, 1999
• Study Completion: August 1, 2000
• Last Updated: June 10, 2011

Record last verified: 2011-06