Nesiritide in Chronic Heart Failure

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure.

Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III & IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period.

Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing.

Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: Scios, Inc.
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

Candidates for enrollment in this clinical trial are limited to adult patients (age>21) diagnosed with chronic heart failure > one year who are managed by heart failure specialists at the University of Chicago. Patients primarily managed by physicians other than the investigators will be enrolled with the concurrence of the treating physician. Study patients are characterized as "high risk" by fulfilling one or more of the following criteria:

1. Refractory class III or IV heart failure despite optimal medical therapy by a heart failure specialist: Angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), beta-adrenergic blockers (BB), spironolactone (spiro), digoxin (dig), diuretics, and calcium channel blockers (CCB).

2. Frequent hospitalizations or ER visits (>1/month on average).

Additionally, patients must be capable of giving informed consent and have adequate social supports to manage chronic, continuous IV infusion therapy with the assistance of home care nursing and the study coordinator.

Exclusion Criteria:

1. Nesiritide infusion >24 hours in the previous 30 days.

2. Stable chronic heart failure or NYHA Class I or II.

3. Aortic stenosis greater than mild degree as determined by echocardiogram or catheterization.

4. Hypertrophic cardiomyopathy with an outflow tract gradient.

5. Isolated right heart failure (cor pulmonale).

6. Unstable coronary syndrome or myocardial infarction< 3 months prior to enrollment.

7. Chronic hypotension with systolic blood pressure < 80 mmHg.

8. Terminal noncardiovascular illness with life expectancy <6 months. Moribund patients will not be considered for enrollment.

9. Active substance abuse.

10. Inadequate social support.

11. Contraindication to long term IV access.

12. Pregnant or lactating females.