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

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

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 failure) when administered serially as a treatment to outpatients with worsening congestive heart failure (decompensated CHF) who are receiving their usual cardiac medications and are at high risk for hospitalization.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.