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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186329
First Posted: September 16, 2005
Last Update Posted: April 28, 2015
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.
Collaborator:
Scios, Inc.
Information provided by (Responsible Party):
Michael Fowler, Stanford University
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: B-type Natriuretic Peptide for Cardio-Renal Decompensation Syndrome

Further study details as provided by Michael Fowler, Stanford University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: March 2004
Estimated Study Completion Date: October 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00186329


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Fowler, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00186329     History of Changes
Other Study ID Numbers: SUMC79741
SPO # 29675
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Michael Fowler, Stanford University:
Vasodilation
Congestive heart failure
Renal insufficiency
Diuresis
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