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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.

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ClinicalTrials.gov Identifier: NCT00270374
Recruitment Status : Completed
First Posted : December 26, 2005
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Scios, Inc.

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.

Condition or disease Intervention/treatment Phase
Symptomatic Decompensated Congestive Heart Failure Congestive Heart Failure in Acute Coronary Syndrome Drug: nesiritide Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 498 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Hemodynamic and Clinical Effects of Natrecor (Nesiritide) Compared With Nitroglycerin Therapy for Symptomatic Decompensated CHF, The VMAC Trial: Vasodilation in the Management of Acute Congestive Heart Failure
Study Start Date : October 1999
Actual Study Completion Date : August 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 001
nesiritide
Drug: nesiritide



Primary Outcome Measures :
  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 Outcome Measures :
  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


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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

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 ClinicalTrials.gov identifier (NCT number): NCT00270374


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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00270374     History of Changes
Other Study ID Numbers: CR005206
First Posted: December 26, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Scios, Inc.:
Congestive heart failure
CHF
Left-sided heart failure
Right-sided heart failure
Systolic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Nitroglycerin
Natriuretic Peptide, Brain
Vasodilator Agents
Natriuretic Agents
Physiological Effects of Drugs