Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166010
Status:
WITHDRAWN
Last Update Posted:
2014-06-05
First Post:
2005-09-12
Brief Title:
Effects of Nesiritide in Pediatric Patients With Heart Failure
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Single-center Pharmacokinetic Evaluation of Nesiritide in the Pediatric Population With Heart Failure
Status:
WITHDRAWN
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Observational study that DSMB placed on hold withdrew 4 subjects Protocol revised and received IND to become interventional PK study no subjects enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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 patients 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
Detailed Description:
Nesiritide human recombinant B-type natriuretic peptide has been recently approved by the Food and Drug Administration for the intravenous treatment of patients with decompensated congestive heart failure Nesiritide has been studied in a broad range of patients including the elderly women and African Americans and patients with a history of various cardiovascular conditions including hypertension diabetes post myocardial infarction atrial fibrillationflutter nonsustained ventricular tachycardia left ventricular diastolic dysfunction and acute coronary syndrome However clinical experience in the pediatric population has been limited
Nesiritide is a human B-type natriuretic peptide BNP produced by recombinant technology having the same amino acid sequence as the naturally occurring human BNP BNP is predominantly secreted by the cardiac ventricles in response to increased cardiac volume and pressure overload Its pharmacologic effects include hemodynamic neurohormonal and renal In adult studies hemodynamic effects are characterized by balanced venous and arterial dilation resulting in decreased preload and afterload demonstrated by a reduction of pulmonary capillary wedge pressure pulmonary arterial pressure and systemic vascular resistance while neurohormonal effects of nesiritide favorably inhibit the renin-angiotension-aldosterone system leading to decreased plasma aldosterone and norepinephrine levels The renal effects most often seen with nesiritide use is increased urine output and lower diuretic utilization
There are currently no published articles discussing the use including pharmacokinetics of nesiritide in children However there are several centers that are currently using the drug - Columbus Missouri San Diego California Charleston South Carolina Loma Linda California Our experience in the infant after cardiac surgery and the older child with heart failure is encouraging In children receiving nesiritide therapy we noted significant clinical improvement with no appreciable side effects Based on our initial experience further prospective studies need to be performed in order to determine the pharmacokinetics and safety of using this therapy in the pediatric cohort
Nesiritide is a human B-type natriuretic peptide BNP produced by recombinant technology having the same amino acid sequence as the naturally occurring human BNP BNP is predominantly secreted by the cardiac ventricles in response to increased cardiac volume and pressure overload Its pharmacologic effects include hemodynamic neurohormonal and renal In adult studies hemodynamic effects are characterized by balanced venous and arterial dilation resulting in decreased preload and afterload demonstrated by a reduction of pulmonary capillary wedge pressure pulmonary arterial pressure and systemic vascular resistance while neurohormonal effects of nesiritide favorably inhibit the renin-angiotension-aldosterone system leading to decreased plasma aldosterone and norepinephrine levels The renal effects most often seen with nesiritide use is increased urine output and lower diuretic utilization
There are currently no published articles discussing the use including pharmacokinetics of nesiritide in children However there are several centers that are currently using the drug - Columbus Missouri San Diego California Charleston South Carolina Loma Linda California Our experience in the infant after cardiac surgery and the older child with heart failure is encouraging In children receiving nesiritide therapy we noted significant clinical improvement with no appreciable side effects Based on our initial experience further prospective studies need to be performed in order to determine the pharmacokinetics and safety of using this therapy in the pediatric cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None