A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure
The purpose of this study is to evaluate the efficacy and safety of Nesiritide administered as serial infusions to heart failure (HF) patients in the outpatient setting.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Follow-up Serial Infusions of Natrecor(Nesiritide) in the Management of Patients With Heart Failure-FUSION II|
- Time to all-cause death or first occurrence of hospitalization for cardiovascular and/or renal causes from the day of randomization through week 12.
- Number of cardiovascular and/or renal hospital admissions adjusted for duration of observation period through the end of week 12. Days alive and out of the hospital from the day of randomization through the end of week 12.
|Study Start Date:||April 2004|
|Study Completion Date:||December 2006|
Heart Failure (HF) is the inability of the heart to pump efficiently and the heart cannot perform the necessary circulation of blood through the body. This can result in symptoms like shortness of breath at rest or with minimal activity. Advanced heart failure is one of the leading causes of hospitalization and deaths in the United States. This is a prospective randomized, double-blind, placebo-controlled parallel group, multicenter study of the effectiveness of Nesiritide administered as serial infusions in the outpatient setting. Patients enrolled in this study will receive nesiritide or placebo for up to 12 weeks. Patients will then be followed for an additional 12 weeks. During the the first 17 weeks of the study patients will have multiple laboratory tests, have their vital signs (blood pressure and heart rate) assessed, and complete quality of life questionnaires. During the last few weeks of the study patients will be contacted to inquire how they are doing. The study hypothesis is that compared to placebo plus standard care, Nesiritide plus standard will reduce time to death or first occurrence of hospitalization due to heart or kidney problems. Safety will be assessed through the collection of adverse events, clinical laboratory tests and vital signs at various time points throughout the study. The patients assigned to the nesiritide group will receive a single 2.0mcg/kg bolus (one time injection) followed by serial IV infusions (4 to 6 hours) at a standard flow rate of 0.010 mcg/kg/min once or twice per week for 12 weeks. The patients assigned to the placebo group will receive matching placebo.