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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Scios, Inc.
• Treatments: Natriuretic Peptide, Brain

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)