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NCT00145873 · ClinicalTrials.gov registry record · Phase 2
Nesiritide in Chronic Heart Failure
A Phase 2 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT00145873 is a Phase 2 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 20 participants.
The verdict
NCT00145873, a Phase 2 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure. Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III \& IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period. Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing. Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.
Interventions
- DRUG nesiritide, continuous infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-08 |
| Est. Completion | 2006-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00145873
The ClinicalTrials.gov registry entry for NCT00145873 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which nesiritide, continuous infusion is the first listed.
NCT00145873 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00145873 about?
NCT00145873 is a clinical study titled "Nesiritide in Chronic Heart Failure". The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Ne...
What is the current status of trial NCT00145873?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2003-08. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00145873?
The interventions under investigation include: nesiritide, continuous infusion (DRUG).
Who is sponsoring clinical trial NCT00145873?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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