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.
Heart Failure, Congestive
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Heart Failure, Renal Dysfunction, Cardiomyopathy, Heart Decompensation, Dyspnea Paroxsymal, Outpatient Therapy.
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
001
002
003
nesiritide
nesiritide
usual long term cardiac medications