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.

This study has been completed.
Sponsor:
Information provided by:
Scios, Inc.
ClinicalTrials.gov Identifier:
NCT00270374
First received: December 22, 2005
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Symptomatic Decompensated Congestive Heart Failure
Congestive Heart Failure in Acute Coronary Syndrome
Drug: 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: 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

Resource links provided by NLM:


Further study details as provided by Scios, Inc.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 498
Study Start Date: October 1999
Study Completion Date: August 2000
Arms Assigned Interventions
Experimental: 001
nesiritide
Drug: 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 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270374

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

Publications:
ClinicalTrials.gov Identifier: NCT00270374     History of Changes
Other Study ID Numbers: CR005206
Study First Received: December 22, 2005
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

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
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Nitroglycerin
Natriuretic Peptide, Brain
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014