Follow-Up Serial Infusions of Natrecor(R) (Nesiritide) for the Management of Patients with Heart Failure-FUSION II

The purpose of this study is to evaluate the efficacy and safety of Natrecor(R) administered as serial infusions to heart failure (HF) patients in the outpatient setting.

Official Title

Conditions

Heart Failure, Congestive

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further Details

Study Start

Study start: March 2004; Expected completion: December 2006

Eligibility & Criteria

Inclusion Criteria:- Are 18 years of age or older – Had at least two qualifying hospitalizations or hospitalization equivalents in the past year, with the most recent hospitalization or hospitalization equivalent within the past 60 days, but who has been out of the hospital at least 5 days (the day of discharge is day 0). – Have documentation indicating that the patient was consistently NYHA Class III or IV during the 60 days before randomization. – Have a LVEF <40% (measured within 24 weeks before randomization). - Are (1)NYHA Class IV or (2)NYHA Class III with highest calculated CrCl, 60mL/min within the previous 30 days. - Are receiving optimal treatment with long-term oral medications (e.g., diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), and beta blockers, unless these are documented to be contraindicated or not tolerated). - Agree to come to the clinic up to 2 times per week (according to randomization) for 16 weeks of study drug infusions and to participate in all required follow-up assessments through week 24. In addition, agree to be contacted monthly after week 24 for follow-up, until the entire study has been completed. - Have available transportation to attend study clinic visits. - Are willing to use two forms of contraception, if female and of childbearing potential, beginning at the time of the screening visit. - Have understood and signed a written Informed Consent Form (including Health Insurance Portability and Accountability Act (HIPPA) authorization, if required) before initiation of protocol-specified procedures. Exclusion Criteria:- Have systolic blood pressure consistently <90mm Hg. - Are unable or unwilling to discontinue intermittent or continuous infusions of dopamine, dobutamine, milrinone, nitroglycerin, or open-label Natrecor beginning at the time of the screening visit. - Have required recent outpatient IV vasoactive (milrinone, dobutamine, dopamine, nitroglycerin, or open-label Natrecor) therapy as defined as >2 outpatient (excluding emergency room or inpatient) infusions in the last 30 days without a subsequent hospitalization. – Had, or during the course of the study are anticipated to have, any organ transplantation (heart, liver, lung, kidney, or bone marrow). – Had a biventricular pacemaker placed within the 45 days before randomization or a single or dual chamber pacemaker or an automatic implantable cardiac defibrillator placed within the 15 days before randomization. – Have cardiogenic shock, volume depletion, or any other clinical condition at the time of randomization that would contraindicate the administration of Natrecor. – Are currently receiving chronic dialysis or have the expectation that dialysis will be required during the next 12 months. – Have a history of an allergic reaction or sensitivity to Natrecor or any of its components. – Have a positive pregnancy test, are pregnant or a nursing mother, or have a suspected pregnancy. – Have a medical condition that is so severe that survival for the treatment and follow-up periods is not likely. – Have a medical condition immediately before randomization that indicates hospitalization is likely within the next week. – Have received therapy with another investigational drug or device within the last 30 days and/or are currently enrolled or anticipate enrolling in another clinical study. – Are unwilling or unable to comply with study requirements including informed consent, up to twice-weekly study visits, and the follow-up period visits. – Have a diagnosis of acute myocardial infarction within the 30 days before randomization as evidenced by changes in ECG, creatine kinase isoenzyme MB, troponin, or nuclear scan.

Total Enrolment

Contact Details

Australia, New South Wales Concord Hospital, Concord, New South Wales, 2139, Australia; Recruiting Australia, South Australia Queen Elizabeth Hospital, Woodville, South Australia, 5011, Australia; Recruiting Flinders Medical Centre, Bedford Park, South Australia, 5042, Australia; Recruiting Australia, Victoria Royal Prince Alfred Hospital, Melbourne, Victoria, 8008, Australia; Recruiting Geelong Hospital, Geelong, Victoria, 3220, Australia; Recruiting