Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

Study Overview
=================
Brief Summary
-----------------
The researchers hypothesize that the addition of nesiritide to standard therapy will prevent worsening of renal function in patients admitted to the hospital with decompensated heart failure and renal dysfunction relative to standard therapy alone.

Official Title
-----------------
Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

Conditions
-----------------
Congestive Heart Failure, Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: Nesiritide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Decompensated heart failure hospitalization with at least 1 symptom and 1 sign of elevated filling pressures Admission estimated creatinine clearance =< 50 cc/min. Exclusion Criteria: Systolic blood pressure < 85 mm Hg Cardiogenic shock Volume depletion Myocardial infarction, unstable angina within last 30 days Significant valvular stenosis, hypertrophic/restrictive cardiomyopathy, or constrictive pericarditis Chronic hemodialysis Anticipated major procedure during hospitalization i.e. left heart catheterization, surgery, or transplantation Enrolled in another research protocol within last 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nesiritide + standard of care<br>Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved. | Drug: Nesiritide<br>* Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.<br>* Other names: Natrecor;|
| Active Comparator: Standard of care<br>Standard of care until adequate diuresis achieved | Drug: Nesiritide<br>* Nesiritide: 1 mcg/kg bolus, followed by a continuous infusion at 0.005 mcg/kg/min which can be titrated every 3 hours by 0.005 mcg/kg/min to maximum dose of 0.03 mcg/kg/min until adequate diuresis achieved.<br>* Other names: Natrecor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function |  | within 7 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | Within 7 days from randomization | 
| Days to optimal volume status |  | From randomization till day 7 or sooner | 
| Concomitant diuretic use |  | Within 7 days from randomization | 
| Global symptom assessment |  | 24 hrs and 3 days after randomization | 
| Length of stay |  | From admission to discharge or day 7 |