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Nesiritide in Transplant-Eligible Management of Congestive Heart Failure-TMAC
This study has been terminated.
( DSMC acknowledged no safety concerns with the trial, recommending that the trial be terminated due to slow enrollment. )
First Received: June 16, 2006   Last Updated: September 28, 2009   History of Changes
Sponsor: Scios, Inc.
Information provided by: Scios, Inc.
ClinicalTrials.gov Identifier: NCT00338455
  Purpose

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 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.


Condition Intervention Phase
Congestive Heart Failure
Cardiac Transplantation
Renal Failure
Renal Insufficiency
Drug: Placebo+ Standard Care + dobutamine or milrinone
Drug: Nesiritide + Standard Care + dobutamine or milrinone
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: Investigation of the Use of Nesiritide in Transplant-Eligible Management of Congestive Heart Failure-TMAC

Resource links provided by NLM:


Further study details as provided by Scios, Inc.:

Primary Outcome Measures:
  • Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Pulmonary Capillary Wedge Pressure (PCWP) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • All Cause Mortality [ Time Frame: Day 30 and Months 2 and 6 ] [ Designated as safety issue: No ]
  • Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: June 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
001: Experimental Drug: Nesiritide + Standard Care + dobutamine or milrinone
Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min
002: Placebo Comparator Drug: Placebo+ Standard Care + dobutamine or milrinone
Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00338455

Sponsors and Collaborators
Scios, Inc.
Investigators
Study Director: Scios R&D, Inc. Clinical Trial Scios, Inc.
  More Information

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( VP Assoc Therapeutic Area Head )
Study ID Numbers: CR003649, A051, TMAC
Study First Received: June 16, 2006
Results First Received: October 22, 2008
Last Updated: September 28, 2009
ClinicalTrials.gov Identifier: NCT00338455     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Scios, Inc.:
ultrafiltration
nesiritide
cardiac transplantation
dialysis
Congestive heart failure
vasodilator
renal insufficiency
renal failure

Additional relevant MeSH terms:
Vasodilator Agents
Renal Insufficiency
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Hematologic Agents
Physiological Effects of Drugs
Adrenergic Agonists
Urologic Diseases
Milrinone
Therapeutic Uses
Cardiovascular Diseases
Kidney Diseases
Natriuretic Peptide, Brain
Heart Failure
Heart Diseases
Adrenergic beta-Agonists
Sympathomimetics
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Dobutamine
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Natriuretic Agents
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Kidney Failure

ClinicalTrials.gov processed this record on November 27, 2009