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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Congestive Heart Failure, Cardiac Transplantation, Renal Insufficiency, Renal Failure

In brief

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.

Key facts

Study ID

NCT00338455

Run by

Scios, Inc.

People needed

16

Starts

2006-09-01

Expected to finish

2007-10-01

Last updated by the study team

2014-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Stanford, California, United States
• Study site — Tampa, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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