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. )

Study NCT00338455. Last updated on December 18, 2008.

Information provided by Scios R&D, Inc.

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Conditions:	Congestive Heart Failure Cardiac Transplantation Renal Failure Renal Insufficiency
Interventions:	Drug: Placebo+ Standard Care + dobutamine or milrinone Drug: Natrecor+ Standard Care + dobutamine or milrinone

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Nesiritide	28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
Placebo	28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.

Participant Flow: Overall Study

	Nesiritide	Placebo
STARTED	9	7
COMPLETED	6	6
NOT COMPLETED	3	1
Death	2	1
Physician Decision	1	0

Baseline Characteristics

Reporting Groups

	Description
Nesiritide	28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
Placebo	28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.

Baseline Measures

	Nesiritide	Placebo	Total
Number of Participants [units: participants]	9	7	16
Age [units: years] Mean ± Standard Deviation	52.0 ± 9.80	54.6 ± 4.65	53.1 ± 7.85
Gender [units: participants]
Female	1	3	4
Male	8	4	12
Glomerular Filtration Rate^[1] [units: Number of Participants]
MDRD-GFR < 60	4	4	8
MDRD-GFR > = 60	5	3	8
Body Mass Index (BMI) [units: kg/m2] Mean ± Standard Deviation	29.4 ± 5.53	31.7 ± 5.79	30.5 ± 5.57

[1]	Estimate of the GFR using serum creatinine and demographic factors.

Outcome Measures

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1. Primary Outcome Measure: Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment)

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2. Secondary Outcome Measure: Changes in Pulmonary Capillary Wedge Pressure (PCWP)

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3. Secondary Outcome Measure: All Cause Mortality

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4. Secondary Outcome Measure: Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean

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Reported Adverse Events

Adverse event information has not been entered for this trial.

The submission of adverse events information is currently optional and is not mandated under U.S. Federal Law (US Public Law 110-85, Title VIII) until September 27, 2009.

More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination of the study due to enrollment difficulties (change in standard of care for patient population as well as changing organ allocation rules by United Network for Organ Sharing); efficacy not analyzed due to limited sample size (n=16).

Results Point of Contact:

Name/Title: Sr. Director Clinical Leader
Organization: Scios R&D, Inc.
phone: 650 564-5084

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:

December 18, 2008

ClinicalTrials.gov Identifier:

NCT00338455

Health Authority:

United States: Food and Drug Administration