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

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00170183
First received: September 13, 2005
Last updated: November 13, 2009
Last verified: November 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BNP as Adjuvant Therapy to Preserve Renal Function and Facilitate Diuresis in Hospitalized Patients With Heart Failure

Resource links provided by NLM:


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
Study Completion Date: July 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  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
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: NCT00170183

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

No publications provided

ClinicalTrials.gov Identifier: NCT00170183     History of Changes
Other Study ID Numbers: 18-03, A005
Study First Received: September 13, 2005
Last Updated: November 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Heart failure
Renal dysfunction

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

ClinicalTrials.gov processed this record on July 24, 2014