Nesiritide in Transplant-Eligible Management of Congestive Heart Failure-TMAC - Full Text View

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:

MedlinePlus related topics: Heart Failure Heart Transplantation Kidney Failure

Drug Information available for: Dobutamine Dobutamine hydrochloride Milrinone Primacor Dobutamine tartrate Dobutamine lactobionate Nesiritide

U.S. FDA Resources

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