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Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure
This study is currently recruiting participants.
Verified by Mayo Clinic, September 2005
Sponsors and Collaborators: Mayo Clinic
Scios, Inc.
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00170183
  Purpose

Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for prolonged length of stay (LOS) and frequent readmissions. Renal dysfunction and diuretic resistance contribute to this risk, particularly if renal dysfunction worsens during CHF treatment. Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with well-defined physiological effects which include arterial and venous vasodilation, suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and sodium excretion. Recombinant human BNP (Natrecor) is approved by the FDA for treatment of decompensated CHF as it has been demonstrated to lower filling pressures and improve symptoms. While clinical trials and the FDA support the use of BNP as adjuvant therapy in decompensated CHF, the extent of its efficacy in improving non-hemodynamic CHF parameters has not been fully defined.

The objective of this clinical practice protocol is to determine whether use of BNP in addition to standard therapy, will preserve renal function and facilitate diuresis in patients with CHF and mild-moderate renal impairment (creatinine clearance > 20 but < 60 ml/min) as compared to standard therapy alone. Patients admitted to the Mayo Heart Failure Service who meet entrance criteria will be randomized to standard clinical practice with or without a 48 hour infusion of BNP.

The primary endpoints will be indices of renal function and diuretic response at 1, 2 and 3 days and at discharge. Secondary endpoints will be neurohumoral function, LOS and 30-day readmission rate.


Condition Intervention Phase
Kidney Diseases
Congestive Heart Failure
Cardiomyopathy
Drug: Nesiritide
Phase III

MedlinePlus related topics: Cardiomyopathy Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: BNP as Adjuvant Therapy to Preserve Renal Function and Facilitate Diuresis in Hospitalized Patients With Heart Failure

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Creatinine, creatinine clearance on days 1, 2, & 3
  • Weight loss on days 1, 2 & 3
  • Fluid balance on days 1, 2 & 3
  • Use of advanced therapy for diuretic resistance
  • Meet criteria for diuretic resistance

Secondary Outcome Measures:
  • Length of stay
  • 30-day re-admission for HF
  • Neuro-hormonal levels (PRA, A-II, ANP, BNP, cGMP, etc)
  • Hemodynamic measurements (systolic blood pressure [SBP], systolic blood pressure [DBP], mean arterial pressure [MAP])

Estimated Enrollment: 104
Study Start Date: March 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of class III-IV CHF requiring hospitalization for treatment of CHF.
  • Mild - moderate renal insufficiency (20< Creatinine Clearance < 60 ml/min as calculated by the Cockcroft-Gault formula)
  • Systolic BP > 90
  • Stable cardiac rhythm
  • Unlikely to require cardiac catheterization

Exclusion Criteria:

  • Inability to give informed consent
  • New onset atrial fibrillation with rapid ventricular response (HR >110 bpm)
  • Active ischemia
  • Known or suspected stenotic valve disease
  • Acute clinical need for intravenous vasodilator (including BNP) therapy (Severely symptomatic despite rest, oxygen, initial standard therapy)
  • Primary reason for admission other than treatment of decompensated CHF (rhythm, device, other medical problem)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170183

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Damita J Carryer     507-255-2200     carryer.damita@mayo.edu    
Principal Investigator: Margaret M Redfield, MD            
Sponsors and Collaborators
Mayo Clinic
Scios, Inc.
Investigators
Principal Investigator: Margaret M. Redfield, M.D. Mayo Clinic
  More Information

Study ID Numbers: 18-03, A005
Study First Received: September 13, 2005
Last Updated: March 14, 2006
ClinicalTrials.gov Identifier: NCT00170183  
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Heart failure
Renal dysfunction

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Urologic Diseases
Kidney Diseases
Cardiomyopathies

Additional relevant MeSH terms:
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009