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Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure

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: NCT00170183
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 16, 2009
Scios, Inc.
Information provided by:
Mayo Clinic

Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Diseases Congestive Heart Failure Cardiomyopathy Drug: Nesiritide Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BNP as Adjuvant Therapy to Preserve Renal Function and Facilitate Diuresis in Hospitalized Patients With Heart Failure
Study Start Date : March 2003
Primary Completion Date : July 2007
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Nesiritide
U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Length of stay
  2. 30-day re-admission for HF
  3. Neuro-hormonal levels (PRA, A-II, ANP, BNP, cGMP, etc)
  4. Hemodynamic measurements (systolic blood pressure [SBP], systolic blood pressure [DBP], mean arterial pressure [MAP])

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

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)

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): NCT00170183

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Scios, Inc.
Principal Investigator: Margaret M. Redfield, M.D. Mayo Clinic

Publications of Results:
Standard Dose Nesiritide Does Not Enhance Diuresis Nor Alter Renal Function in Decompensated Heart Failure. J Card Fail 2005, in press. Circulation 2005, in press. Identifier: NCT00170183     History of Changes
Other Study ID Numbers: 18-03
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 16, 2009
Last Verified: November 2009

Keywords provided by Mayo Clinic:
Heart failure
Renal dysfunction

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