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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

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

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

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

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4