Status:
COMPLETED
A Safety Study Comparing Natrecor (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure
Lead Sponsor:
Scios, Inc.
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 normal...
Detailed Description
Advanced congestive heart failure (CHF) accounts for over one million hospital admissions yearly in the U.S. and is associated with a 2-year mortality rate of up to 40% - 50% (according to the America...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1999
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00270400
Start Date
August 1 1998
End Date
February 1 1999
Last Update
June 10 2011
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