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:
Scios, Inc.
Information provided by:
Scios, Inc.
ClinicalTrials.gov Identifier:
NCT00270374
First received: December 22, 2005
Last updated: June 9, 2011
Last verified: June 2011
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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
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 May 16, 2013