ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
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. )

Sponsored by: Scios R&D, Inc.
Information provided by: Scios R&D, 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
Renal Insufficiency.
Dialysis
Congestive Heart Failure
Cardiac Transplantation
Renal Failure
Drug: Natrecor+ Standard Care + dobutamine or milrinone
Drug: Placebo+ Standard Care + dobutamine or milrinone
Phase II
Phase III

MedlinePlus related topics:   Heart Failure    Heart Transplantation    Kidney Failure   

ChemIDplus related topics:   Nesiritide    Dobutamine    Dobutamine hydrochloride    Dobutamine lactobionate    Dobutamine tartrate    Milrinone   

U.S. FDA Resources

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

Further study details as provided by Scios R&D, Inc.:

Primary Outcome Measures:
  • The primary efficacy endpoint for this study is the number of days alive without renal, hemodynamic, or electrical clinical worsening through Day 28 (Termination of Treatment). [ Time Frame: 28days. The # of calendar days alive without renal, hemodynamic, or electrical clinical worsening through Day 28 (Termination of Treatment or early discontinuation of treatment, whichever occurs first). The endpoint is not normalized for time on study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The following endpoints will be assessed during the 28-day treatment period; changes in pulmonary capillary wedge pressure (PCWP); changes in pulmonary artery pressure (PAP) (systolic, diastolic, and mean) [ Time Frame: 28 days. Change in pulmonary capillary wedge pressure (PCWP) ; ,Change in pulmonary artery pressure (PAP) (systolic, diastolic, and mean ; - through day 28. All cause mortality was also assessed at Day 30 and months 2 and 6. ] [ Designated as safety issue: No ]

Enrollment:   16
Study Start Date:   June 2006
Study Completion Date:   October 2007

Arms Assigned Interventions
001: Experimental Drug: Natrecor+ Standard Care + dobutamine or milrinone
28-day con't infus, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015
002: Placebo Comparator Drug: Placebo+ Standard Care + dobutamine or milrinone
28-day con't infus, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015

Show detailed description  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 R&D, Inc.

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

Responsible Party:   Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( VP Assoc Therapeutic Area Head )
Study ID Numbers:   CR003649, TMAC, A051
First Received:   June 16, 2006
Last Updated:   May 15, 2008
ClinicalTrials.gov Identifier:   NCT00338455
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Heart Failure
Renal Insufficiency
Heart Diseases
Urologic Diseases
Milrinone
Kidney Diseases
Dobutamine
Kidney Failure

Additional relevant MeSH terms:
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Adrenergic Agents
Cardiotonic Agents
Sympathomimetics
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Adrenergic Agonists
Phosphodiesterase Inhibitors
Natriuretic Agents
Autonomic Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2008




Links to all studies - primarily for crawlers