Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC

• Status: Terminated
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scios, Inc.
• Treatments: Dobutamine; Milrinone; Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• Meet the criteria for a United Network for Organ Sharing (UNOS) Status 1B heart transplant candidate, or, if outside the US, have comparable status

• must also be a primary transplant candidate waiting to receive a single cardiac allograft

• must be receiving continuous intravenous infusion of dobutamine or milrinone through a double-lumen central catheter or a double-lumen percutaneously inserted central catheter for at least 3 consecutive days before randomization

• must be willing and able to participate in the study assessments and follow up procedures

• male and female subjects of childbearing potential agree to use two highly effective methods of birth control for the duration of the study.

Exclusion Criteria:

• Not have systolic blood pressure (SBP) consistently < 80 mm Hg, or have clinically significant orthostatic hypotension

• not weigh > 130 kg

• not have a ventricular assist device (VAD), or anticipate the need for a VAD, during the 28-day study drug treatment period

• not have received placement of an internal cardiac defibrillator (ICD) or external cardiac defibrillator (ECD) within 72 hours before randomization

• not require chronic hemodialysis or peritoneal dialysis to treat renal failure, or had acute dialysis or ultrafiltration within 7 days before randomization

• not have received antibiotic treatment within 7 days before randomization-antibiotics are permissible for any prophylactic use.