Nesiritide in Chronic Heart Failure
The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure.
Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III & IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period.
Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing.
Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Continuous Infusion Nesiritide in Chronic Heart Failure-University of Chicago (CINCH-UC)|
- Outcome measurements will include change in functional capacity (NYHA, 6 min walk)- done upon enrollment and day 42,
- MLHFQ score done upon enrollment and day 42
- hospitalizations/ER visits history done at day 1, 7, 14, 21, 28, 42, 49, 56, 63, 70, 84
- Levels of blood urea nitrogen, serum creatinine, and N-terminal pro-BNp - upon enrollment and at days 7, 14, 21, 28, 42, 49, 56, 63, 70, 84
|Study Start Date:||August 2003|
|Estimated Study Completion Date:||June 2008|
This is a single center, double-blinded, crossover, placebo-controlled pilot study to evaluate the effects of nesiritide in patients with chronic heart failure. This study will only take place at the University of Chicago Hospitals. It is double-blinded, which means that the neither subject nor their study doctor will know which study drug the subject will receive. However, in an emergency, this information can be obtained quickly. The study is placebo-controlled, which means subjects will not receive study drug at some point during the study; however because it is a cross-over study, subjects will be receiving nesiritide at some point in the study. Subjects will receive the study drug nesiritide for six out of the 12 weeks of the study—either the first six weeks or the last six weeks.
The procedures for the study consist of: informed consent, questions about the subjects heart failure, blood sample, assessment of heart failure severity based on symptoms, six minute walk test and the Minnesota Living with Heart Failure Questionnaire, history of heart failure symptoms and emergency room visits, diuretic and baseline medication history, long term IV for medication infusions, adjustment of study drug and regularly taken medications, 6 weeks of receiving long term IV infusion of drug, blood taken for lab tests at each clinic visit and an informational card provided for subjects to use for on-call physicians.
Up to ten consecutive patients who decline participation in the study will be asked to participate in a registry to follow their course over the study interval. Baseline data, obtained from medical records will be recorded as will the number of hospitalizations/ER visits and NYHA class during the study period. These subjects will be surveyed by telephone monthly for the duration of the study.
|United States, Illinois|
|University of Chicago Hospitals|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Allen Anderson, MD||University of Chicago|