drugset / Trial / NCT00186329
BNP for Cardio-Renal Decompensation Syndrome (BNP-CARDS)
RandomizedSingle-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2004-03
- Primary completion
- —
- Completion
- 2006-10
Publications
- Background Sackner-Bernstein JD, Skopicki HA, Aaronson KD. Risk of worsening renal function with nesiritide in patients with acutely decompensated heart failure. Circulation. 2005 Mar 29;111(12):1487-91. doi: 10.1161/01.CIR.0000159340.93220.E4. Epub 2005 Mar 21.
- Background Sackner-Bernstein JD, Kowalski M, Fox M, Aaronson K. Short-term risk of death after treatment with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials. JAMA. 2005 Apr 20;293(15):1900-5. doi: 10.1001/jama.293.15.1900.
- Background Wang DJ, Dowling TC, Meadows D, Ayala T, Marshall J, Minshall S, Greenberg N, Thattassery E, Fisher ML, Rao K, Gottlieb SS. Nesiritide does not improve renal function in patients with chronic heart failure and worsening serum creatinine. Circulation. 2004 Sep 21;110(12):1620-5. doi: 10.1161/01.CIR.0000141829.04031.25. Epub 2004 Aug 30.
- Background Colucci WS, Elkayam U, Horton DP, Abraham WT, Bourge RC, Johnson AD, Wagoner LE, Givertz MM, Liang CS, Neibaur M, Haught WH, LeJemtel TH. Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure. Nesiritide Study Group. N Engl J Med. 2000 Jul 27;343(4):246-53. doi: 10.1056/NEJM200007273430403.
- Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.
- Witteles RM, Kao D, Christopherson D, Matsuda K, Vagelos RH, Schreiber D, Fowler MB. Impact of nesiritide on renal function in patients with acute decompensated heart failure and pre-existing renal dysfunction a randomized, double-blind, placebo-controlled clinical trial. J Am Coll Cardiol. 2007 Nov 6;50(19):1835-40. doi: 10.1016/j.jacc.2007.03.071. Epub 2007 Oct 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nesiritide | Protein / enzyme biologic | 0.01 ug/kg | Intravenous |