Status:
COMPLETED
FUSION I Assesses Safety and Tolerability of Two Doses of NATRECOR (Nesiritide) Administered to Patients With Worsening Congestive (Decompensated) Heart Failure Who Are Concurrently Receiving Their Usual Cardiac Medications and Are at High Risk for Hospitalization.
Lead Sponsor:
Scios, Inc.
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and tolerability of two doses of nesiritide (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failu...
Detailed Description
Efforts to contain rising costs for hospital acute care have resulted in shorter hospital stays for patients with acutely decompensated heart failure. These shorter stays may not allow for adequate di...
Eligibility Criteria
Inclusion
- Subjects having had at least two hospital admissions (or equivalent treatment) for acutely decompensated CHF within the last 12 months, with at least one of these admissions in the past 30 days, and having received treatment with intravenous vasoactive agents (such as intravenous inotropes, NATRECOR®, or nitroglycerin)
- able to be enrolled and initiate treatment with study drug within 5 to 30 days of last hospital discharge (or equivalent treatment) of acutely decompensated CHF
- have a baseline NYHA (New York Heart Association) Functional Classification III or IV for at least 2 months prior to randomization
- currently receiving optimal treatment with long term oral medications (e.g., diuretics, ACE inhibitors, and beta blockers, unless beta blockers or ACE inhibitors are documented to be contraindicated or not tolerated)
- willing to receive infusions of NATRECOR®, or possibly other medications, at least as frequently as once per week for 12 weeks.
Exclusion
- Subjects having systolic blood pressure consistently less than 90 mm Hg
- having had organ transplantation (heart, liver, lung and kidney) in the past or anticipating organ transplantation during the study
- not able or willing to discontinue intermittent or continuous infusions of inotropes if randomized to a NATRECOR® treatment group
- having had a bi-ventricular pacemaker placed within the past 60 days or an automatic implantable cardiac defibrillator placed within the past 30 days
- requiring chronic dialysis or have an expectation that dialysis will be required during the course of the study.
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00270361
Start Date
December 1 2001
End Date
January 1 2003
Last Update
July 26 2011
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