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 Information provided by Scios, Inc.

First Received: June 16, 2006 Last Updated: September 28, 2009 History of Changes

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: Nesiritide + Standard Care + dobutamine or milrinone

Participant Flow

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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 + 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.
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.

Participant Flow: Overall Study

	Nesiritide + Standard Care + Dobutamine or Milrinone	Placebo + Standard Care + Dobutamine or Milrinone
STARTED	9	7
COMPLETED	6	6
NOT COMPLETED	3	1
Death	2	1
Physician Decision	1	0

Baseline Characteristics

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Reporting Groups

	Description
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.
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.

Baseline Measures

	Nesiritide + Standard Care + Dobutamine or Milrinone	Placebo + Standard Care + Dobutamine or Milrinone	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 (GFR)^[1] [units: Number of Participants]
GFR < 60	4	4	8
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:

Number of Days Alive Without Renal, Hemodynamic, or Electrical Clinical Worsening Through Day 28 (Termination of Treatment) [ 28 days ]

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2. Secondary:

Changes in Pulmonary Capillary Wedge Pressure (PCWP) [ 28 days ]

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3. Secondary:

All Cause Mortality [ Day 30 and Months 2 and 6 ]

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4. Secondary:

Changes in Pulmonary Artery Pressure (PAP): Systolic, Diastolic, and Mean [ 28 days ]

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Serious Adverse Events

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Time Frame	Safety evaluations were to be performed on treatment and at Months 2 and 6.
Additional Description	No text entered.

Reporting Groups

	Description
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.
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.

Serious Adverse Events

	Nesiritide + Standard Care + Dobutamine or Milrinone	Placebo + Standard Care + Dobutamine or Milrinone
Total, serious adverse events
# participants affected / at risk	4/8 (50.00%)	3/7 (42.86%)
Cardiac disorders
cardiac failure ^†^A # participants affected / at risk	0/8 (0.00%)	1/7 (14.29%)
Immune system disorders
anaphylactic reaction ^†^A # participants affected / at risk	0/8 (0.00%)	1/7 (14.29%)
Infections and infestations
sepsis ^†^A # participants affected / at risk	1/8 (12.50%)	0/7 (0.00%)
pneumonia ^†^A # participants affected / at risk	1/8 (12.50%)	0/7 (0.00%)
gastroenteritis ^†^A # participants affected / at risk	1/8 (12.50%)	0/7 (0.00%)
staphylococcal sepsis ^†^A # participants affected / at risk	0/8 (0.00%)	1/7 (14.29%)
Metabolism and nutrition disorders
hypovolaemia ^†^A # participants affected / at risk	0/8 (0.00%)	1/7 (14.29%)
Nervous system disorders
convulsion ^†^A # participants affected / at risk	0/8 (0.00%)	1/7 (14.29%)
Respiratory, thoracic and mediastinal disorders
pneumothorax ^†^A # participants affected / at risk	1/8 (12.50%)	0/7 (0.00%)
cardiac failure congestive ^†^A # participants affected / at risk	3/8 (37.50%)	1/7 (14.29%)
dyspnoea ^†^A # participants affected / at risk	1/8 (12.50%)	0/7 (0.00%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, MedDRA (9.0)

Other Adverse Events

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More Information

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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

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