Status:
TERMINATED
Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
Lead Sponsor:
Scios, Inc.
Conditions:
Congestive Heart Failure
Cardiac Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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). Th...
Detailed Description
Endogenous B-type natruretic peptide (BNP) concentrations correlate with heart failure (HF) severity and are significantly elevated in severe end-stage HF patients. However, normal biologic compensato...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00338455
Start Date
September 1 2006
End Date
October 1 2007
Last Update
December 8 2014
Active Locations (14)
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1
Stanford, California, United States
2
Tampa, Florida, United States
3
Chicago, Illinois, United States
4
Maywood, Illinois, United States