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

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186329
First received: September 13, 2005
Last updated: January 26, 2007
Last verified: January 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: B-Type Natriuretic Peptide for Cardio-Renal Decompensation Syndrome

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00186329     History of Changes
Other Study ID Numbers: SUMC79741, SPO # 29675
Study First Received: September 13, 2005
Last Updated: January 26, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Vasodilation
Congestive heart failure
Renal insufficiency
Diuresis
Serum creatinine

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

ClinicalTrials.gov processed this record on October 23, 2014