Effects of Nesiritide in Pediatric Patients With Heart Failure
Status:
Withdrawn
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
Children with severe heart failure need immediate appropriate care. New and better drugs are
constantly being developed. As these drugs are approved for adult use, they are used
off-label for children. The Food and Drug Administration (FDA) encourages clinical studies of
drugs in children to further extend appropriate use of new medicines.
This study involves nesiritide, which was approved as a congestive heart failure treatment in
adults in August 2001. The investigators' use of this drug in a pediatric population with
severe heart failure has been encouraging. The investigators now wish to formally determine
the pharmacokinetic and safety of Nesiritide in children.
The investigators will enroll 30 patients who are in the cardiac intensive care unit with
severe heart failure. The data collected will include weights, vital signs, laboratory
results, and echocardiography results. A research lab test called B-type natriuretic peptide
(BNP) will be done several times during this study. If the patient still has an intravenous
(IV) catheter, the blood sample will be taken from the IV. If the patient does not have an
IV, the sample will be taken from a fingerstick.
The duration of the study will be the first 2 days of the patient's stay in the cardiac
intensive care unit and thru discharge to evaluate the endpoint safety of Nesiritide.
Additional information will also be collected if patient gets re-admitted within 30 days of
discharge.