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

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

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

Sponsored by:	Scios R&D, Inc.
Information provided by:	Scios R&D, Inc.
ClinicalTrials.gov Identifier:	NCT00338455