A Safety Study Comparing Natrecor (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure
This study has been completed.
Sponsor:
Scios, Inc.
Information provided by:
Scios, Inc.
ClinicalTrials.gov Identifier:
NCT00270400
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 effects on heart rate and ventricular arrhythmias (irregular heart beats) of two doses of Natrecor® (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) versus dobutamine, during the first 24 hours of treatment of decompensated congestive heart failure (CHF).
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure, Congestive |
Drug: nesiritide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Natrecor (Nesiritide) Versus Dobutamine Therapy for Symptomatic, Decompensated CHF: A Safety Study Using 24-Hour Holter Monitoring - The PRECEDENT Trial: Prospective, Randomized Evaluation of Cardiac Ectopy With Dobutamine or Natrecor Therapy |
Resource links provided by NLM:
Further study details as provided by Scios, Inc.:
Primary Outcome Measures:
- Average heart rate; average hourly premature ventricular beats; average hourly repetitive beats, all expressed as a change from baseline
Secondary Outcome Measures:
- Incidence of tachycardia through 24 hours; Incidence of tachycardia, pain, and injection site reaction through 14 days .
| Enrollment: | 255 |
| Study Start Date: | August 1998 |
| Study Completion Date: | February 1999 |
| 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:
- History of NYHA (New York Heart Association) Class III or IV congestive heart failure (CHF)
- Has symptomatic, decompensated CHF for which inpatient therapy with either dobutamine or Natrecor®, administered as a single intravenous vasoactive agent (drugs that influence the tone and caliber of blood vessels) with or without diuretics, is deemed appropriate
- Receiving stable doses of oral antiarrhythmic medications (medications that help regulate irregular heart beats) for at least the 48 hours before starting study drug, or receiving no antiarrhythmic medications.
Exclusion Criteria:
- Cannot tolerate a 24-Hour Baseline Holter Monitoring Period without intravenous vasoactive medications, and/or cannot tolerate the specified washout period (if applicable) of intravenous vasoactive medications before starting the baseline Holter monitoring
- Has systolic blood pressure consistently < 85 mm Hg, cardiogenic shock, or other evidence of significant hemodynamic instability requiring the immediate institution of inotropic/pressor support
- Has a clinical condition expected to require therapy with more than one intravenous vasoactive agent or Dopamine during the 24-Hour Treatment Holter Monitoring Period
- Has received treatment with Dopamine or any intravenous vasoactive medication such as Dobutamine, Milrinone, Nitroprusside or intravenous Nitroglycerin for more than 4 hours for the current episode of decompensated CHF or related illness
- Requires an intravenous antiarrhythmic medication during the 48 hours before starting the study
Contacts and Locations
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00270400 History of Changes |
| Other Study ID Numbers: | CR005200 |
| Study First Received: | December 22, 2005 |
| Last Updated: | June 9, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Scios, Inc.:
|
Heart Failure Renal Dysfunction Cardiomyopathy Heart Decompensation Dyspnea Paroxsymal. |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Dobutamine Natriuretic Peptide, Brain Cardiotonic Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Sympathomimetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents Natriuretic Agents |
ClinicalTrials.gov processed this record on May 23, 2013