Natrecor (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 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.

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

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure Heart Transplantation

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 ]
Number of calendar days alive without renal, hemodynamic, or electrical clinical worsening through Day 28 (termination of treatment or early discontinuation of treatment, whichever occurred first). The endpoint was not normalized for time on study.

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:	September 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 Natrecor (nesiritide)+Standard Care+dobutamine or milrinone 28-day continuous infusion no bolus 3-hour 0.005 mcg/kg/min may be titrated to 0.015 mcg/kg/min	Drug: Natrecor (nesiritide)+Standard Care+dobutamine or milrinone 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min
Placebo Comparator: 002 Placebo+Standard Care+dobutamine or milrinone 28-day continuous infusion no bolus 3-hour 0.005 mcg/kg/min may be titrated to 0.015 mcg/kg/min	Drug: Placebo+Standard Care+dobutamine or milrinone 28-day continuous infusion, no bolus

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, Inc. Clinical Trial

Scios, Inc.

More Information

No publications provided

Responsible Party:	VP Assoc Therapeutic Area Head
ClinicalTrials.gov Identifier:	NCT00338455 History of Changes
Other Study ID Numbers:	CR003649, A051, TMAC
Study First Received:	June 16, 2006
Results First Received:	October 22, 2008
Last Updated:	March 4, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Scios, Inc.:

Congestive heart failure
cardiac transplantation
renal insufficiency
renal failure

dialysis
ultrafiltration
vasodilator
Natrecor (nesiritide)

Additional relevant MeSH terms:

Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Dobutamine
Milrinone
Natriuretic Peptide, Brain
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Natriuretic Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012