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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00186329
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : April 28, 2015
Scios, Inc.
Information provided by (Responsible Party):
Michael Fowler, Stanford University

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Exacerbation Renal Insufficiency Drug: Natrecor, a recombinant form of B-type Natriuretic Peptide, made by Scios, Inc. vs. placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: B-type Natriuretic Peptide for Cardio-Renal Decompensation Syndrome
Study Start Date : March 2004
Study Completion Date : October 2006

Primary Outcome Measures :
  1. Prevention of worsened renal dysfunction (defined peak serum creatinine >20% higher than at time of admission)
  2. Change in serum creatinine (% and absolute) from admission to discharge- or at 7 days if patient still admitted.

Secondary Outcome Measures :
  1. Net negative diuresis at least 1 L/24 hours while on infusion.
  2. Change in plasma BNP levels (meas. at admission & d/c)
  3. Need to discontinue infusion due to symptomatic hypotension.
  4. Total diuretic use
  5. Resource utilization (days in hospital etc.)
  6. Need for inotropic therapy
  7. Readmission within 30 days

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00186329

United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Scios, Inc.
Principal Investigator: Michael B Fowler, MB Professor, School of Medicine, Stanford University
Study Director: Ronald Witteles, MD Cardiology Fellow, Stanford University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Fowler, Principle Investigator, Stanford University Identifier: NCT00186329     History of Changes
Other Study ID Numbers: SUMC79741
SPO # 29675
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Michael Fowler, Stanford University:
Congestive heart failure
Renal insufficiency
Serum creatinine

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs