Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure
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.
Congestive Heart Failure
|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|
- 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
- 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])
|Study Start Date:||March 2003|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|