Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC
Condition: Congestive Heart Failure; Cardiac Transplantation; Renal Insufficiency; Renal Failure
MeSH terms: Renal Insufficiency; Heart Failure
Intervention: Natrecor (nesiritide)+Standard Care+dobutamine or milrinone; Placebo+Standard Care+dobutamine or milrinone
Intervention description: 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min; 28-day continuous infusion, no bolus
Intervention MeSH terms: Dobutamine; Milrinone; Natriuretic Peptide, Brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Congestive heart failure; cardiac transplantation; renal insufficiency; renal failure; dialysis; ultrafiltration; vasodilator; Natrecor (nesiritide)

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.
    

Eligibility 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.