Effects of Nesiritide in Pediatric Patients With Heart Failure

NCT00166010 | Withdrawn DMC

• 1 other identifier: IRB00003353
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Heart Failure; Ventricular Dysfunction; Heart Decompensation

Keywords

drug; pediatrics; cardiac; Children with Cardiac Ventricular Failure

Outcome Measures

Primary Outcomes (1)

• To determine pharmacokinetics and safety of nesiritide in children

  study period - first 2 days stay in cardiac intensive care unit thru hospital discharge and re-admission within 30 days of discharge.

Study Arms (1)

Nesiritide

EXPERIMENTAL

Drug: Nesiritide

Interventions

Nesiritide DRUG

Standard dose of nesiritide which is a loading dose of 1 mcg/kg IV over 30 minutes followed by a nesiritide infusion at 0.01mcg/kg/min. All patients will be continually evaluated. At any time the attending physician may add or adjust treatment if deemed clinically indicated.

Nesiritide

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age newborn to 18 years.
• Patients admitted to the CICU at Children's Healthcare of Atlanta in heart failure defined as decreased cardiac function and/or volume overload or admitted to the CICU at Children's Healthcare of Atlanta post-operatively after congenital heart defect repair surgery with increasing filling pressures and decreased ventricular compliance as seen by intracardiac line monitoring and echocardiography.
• Receiving or about to receive nesiritide as medical therapy.
• Informed consent will be signed by parent or guardian for all patients. (assent if applicable).

You may not qualify if:

• Patients requiring extra corporeal membrane oxygenation (ECMO) support.
• Patients requiring central veno-venous hemofiltration (CVVH).
• Patients that are pregnant
• Parent or legal guardian (or patient when applicable) refuses to sign informed consent.

Sponsors & Collaborators

• Emory University: lead
• Children's Healthcare of Atlanta: collaborator

Related Publications (4)

• Elkayam U, Akhter MW, Tummala P, Khan S, Singh H. Nesiritide: a new drug for the treatment of decompensated heart failure. J Cardiovasc Pharmacol Ther. 2002 Jul;7(3):181-94. doi: 10.1177/107424840200700308.

  PMID: 12232567 BACKGROUND

• Marcus LS, Hart D, Packer M, Yushak M, Medina N, Danziger RS, Heitjan DF, Katz SD. Hemodynamic and renal excretory effects of human brain natriuretic peptide infusion in patients with congestive heart failure. A double-blind, placebo-controlled, randomized crossover trial. Circulation. 1996 Dec 15;94(12):3184-9. doi: 10.1161/01.cir.94.12.3184.

  PMID: 8989127 BACKGROUND

• Abraham WT, Lowes BD, Ferguson DA, Odom J, Kim JK, Robertson AD, Bristow MR, Schrier RW. Systemic hemodynamic, neurohormonal, and renal effects of a steady-state infusion of human brain natriuretic peptide in patients with hemodynamically decompensated heart failure. J Card Fail. 1998 Mar;4(1):37-44. doi: 10.1016/s1071-9164(98)90506-1.

  PMID: 9573502 BACKGROUND

• Mills RM, LeJemtel TH, Horton DP, Liang C, Lang R, Silver MA, Lui C, Chatterjee K. Sustained hemodynamic effects of an infusion of nesiritide (human b-type natriuretic peptide) in heart failure: a randomized, double-blind, placebo-controlled clinical trial. Natrecor Study Group. J Am Coll Cardiol. 1999 Jul;34(1):155-62. doi: 10.1016/s0735-1097(99)00184-9.

  PMID: 10400005 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Janet M Simsic, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 14, 2005
• Study Start: October 1, 2004
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 5, 2014

Record last verified: 2014-06