drugset / Trial / NCT00338455
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
RandomizedParallel-groupTriple-blindTreatment
Summary
The purposes of this study in United Network for Organ Sharing (UNOS) Status 1B (or country equivalent) cardiac transplant candidates are to assess the safety and efficacy of Natrecor (nesiritide). The study will evaluate the drug's ability to prevent clinical worsening when administered as a 28-day continuous intravenous infusion in patients receiving standard care and continuous intravenous infusion of dobutamine or milrinone.
Timeline
- Start
- 2006-09
- Primary completion
- 2007-10
- Completion
- 2007-10
Outcome
Outcome not reported
Stopped (Enrollment): “DSMC acknowledged no safety concerns with the trial, recommending that the trial be terminated due to slow enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nesiritide | Protein / enzyme biologic | 0.015 ug/kg | Intravenous |
| Background | Dobutamine | Small molecule | — | Intravenous |
| Background | Milrinone | Small molecule | — | Intravenous |