BNP for Cardio-Renal Decompensation Syndrome (BNP-CARDS)
Many patients with exacerbations of heart failure have significant concomitant kidney dysfunction. The combination of these two conditions makes pharmacological management difficult. In this study, we plan to randomize patients with heart failure and kidney dysfunction to receive infusions of Natrecor (B-type Natriuretic Peptide)--which may be beneficial to the management of these two diseases--or placebo.
Congestive Heart Failure Exacerbation
Drug: Natrecor, a recombinant form of B-type Natriuretic Peptide, made by Scios, Inc. vs. placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||B-Type Natriuretic Peptide for Cardio-Renal Decompensation Syndrome|
- Prevention of worsened renal dysfunction (defined peak serum creatinine >20% higher than at time of admission)
- Change in serum creatinine (% and absolute) from admission to discharge- or at 7 days if patient still admitted.
- Net negative diuresis at least 1 L/24 hours while on infusion.
- Change in plasma BNP levels (meas. at admission & d/c)
- Need to discontinue infusion due to symptomatic hypotension.
- Total diuretic use
- Resource utilization (days in hospital etc.)
- Need for inotropic therapy
- Readmission within 30 days
|Study Start Date:||March 2004|
|Estimated Study Completion Date:||October 2006|
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|Principal Investigator:||Michael B Fowler, MB||Professor, School of Medicine, Stanford University|
|Study Director:||Ronald Witteles, MD||Cardiology Fellow, Stanford University|