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Sponsors and Collaborators: |
Mayo Clinic Scios, Inc. |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00170183 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | BNP as Adjuvant Therapy to Preserve Renal Function and Facilitate Diuresis in Hospitalized Patients With Heart Failure |
Estimated Enrollment: | 104 |
Study Start Date: | March 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Damita J Carryer 507-255-2200 carryer.damita@mayo.edu | |
Principal Investigator: Margaret M Redfield, MD |
Principal Investigator: | Margaret M. Redfield, M.D. | Mayo Clinic |
Study ID Numbers: | 18-03, A005 |
Study First Received: | September 13, 2005 |
Last Updated: | March 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00170183 |
Health Authority: | United States: Institutional Review Board |
Heart failure Renal dysfunction |
Natriuretic Peptide, Brain Heart Failure Heart Diseases |
Urologic Diseases Kidney Diseases Cardiomyopathies |
Natriuretic Agents Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |