BNP for Cardio-Renal Decompensation Syndrome (BNP-CARDS)

NCT00186329 | Completed Phase 4

• 2 other identifiers: SUMC79741SPO # 29675
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congestive Heart Failure Exacerbation; Renal Insufficiency

Keywords

Vasodilation; Congestive heart failure; Renal insufficiency; Diuresis; Serum creatinine

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (7)

• 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.)

Interventions

Natrecor, a recombinant form of B-type Natriuretic Peptide, made by Scios, Inc. vs. placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute admission to hospital with CHF exacerbation
• calculated creatinine clearance between 15-60ml/min using the Cockroft Gault equation.

You may not qualify if:

• hypotension (SBP \< 90mmHg)
• hypertension (SBP \> 170 mmHg) necessitating vasodilator therapy
• known allergy to Natrecor
• history of heart transplantation
• contraindications to vasodilator therapy (i.e. severe aortic stenosis)
• up-front use of inotropes
• mental incompetence meaning inability to provide informed consent

Sponsors & Collaborators

• Stanford University: lead
• Scios, Inc.: collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (6)

• 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.

  PMID: 15781736 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.

  PMID: 15840865 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.

  PMID: 15337695 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.

  PMID: 10911006 BACKGROUND

• 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.

  PMID: 39878152 DERIVED

• 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.

  PMID: 17980248 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Aneurysm; Heart Failure

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Michael B Fowler, MB

  Professor, School of Medicine, Stanford University

  PRINCIPAL INVESTIGATOR

• Ronald Witteles, MD

  Cardiology Fellow, Stanford University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2004
• Study Completion: October 1, 2006
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

US (1)