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

NCT00170183 | Completed Phase 3

• 2 other identifiers: 18-03A005
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases; Congestive Heart Failure; Cardiomyopathy

Keywords

Heart failure; Renal dysfunction

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• 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])

Interventions

Nesiritide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• Scios, Inc.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Kidney Diseases; Heart Failure; Cardiomyopathies; Renal Insufficiency

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Margaret M. Redfield, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2008
• Last Updated: November 16, 2009

Record last verified: 2009-11

Locations

US (1)