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NCT00170183 · ClinicalTrials.gov registry record · Phase 3
Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
NCT00170183: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT00170183 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 104 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00170183, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
Study 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.
Interventions
- DRUG Nesiritide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2003-03 |
| Est. Completion | 2008-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00170183
The ClinicalTrials.gov registry entry for NCT00170183 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nesiritide is the first listed.
NCT00170183 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00170183 about?
NCT00170183 is a clinical study titled "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 pept...
What is the current status of trial NCT00170183?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2003-03. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00170183?
The interventions under investigation include: Nesiritide (DRUG).
Who is sponsoring clinical trial NCT00170183?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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