Heart FailureNCT00166010
Effects of Nesiritide in Pediatric Patients With Heart Failure
A study testing Nesiritide in people with Heart Failure and Ventricular Dysfunction, run by Emory University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Heart Failure, Ventricular Dysfunction, Heart Decompensation
- What is being tested?
- Nesiritide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: A Single-center, Pharmacokinetic Evaluation of Nesiritide in the Pediatric Population With Heart Failure
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.
Read more
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.
Read the 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 fibrillation/flutter, 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.
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Decompensation
- Being tested
- Nesiritide
- Keywords
- drug, pediatrics, cardiac, Children with Cardiac Ventricular Failure
- Medical subject headings
- Heart Failure, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NesiritideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nesiritide | Experimental | Not described Receives: Drug: Nesiritide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine pharmacokinetics and safety of nesiritide in children
Measured: study period - first 2 days stay in cardiac intensive care unit thru hospital discharge and re-admission within 30 days of discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Observational study that DSMB placed on hold (withdrew 4 subjects). Protocol revised and received IND to become interventional PK study (no subjects enrolled).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Janet Simsic, MD, Emory University
- Investigators
- Janet M Simsic, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166010
- Sponsor's protocol ID
- IRB00003353
- Status last verified
- Jun 2014
- First submitted
- 12 Sep 2005
- Last updated
- 5 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12232567Marcus 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.
PubMed 8989127Abraham 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.
PubMed 9573502Mills 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.
PubMed 10400005
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Pharmacokinetic Evaluation of Nesiritide in the Pediatric Population With Heart Failure
- ClinicalTrials.gov ID
- NCT00166010
- Acronym / sponsor ID
- IRB00003353
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Decompensation
- Keywords
- drug, pediatrics, cardiac, Children with Cardiac Ventricular Failure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Observational study that DSMB placed on hold (withdrew 4 subjects). Protocol revised and received IND to become interventional PK study (no subjects enrolled).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Oct 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 fibrillation/flutter, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nesiritide | Experimental | Drug: Nesiritide |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NesiritideStandard 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. | Drug | Nesiritide |
Primary outcome
To determine pharmacokinetics and safety of nesiritide in children
Time frame: study period - first 2 days stay in cardiac intensive care unit thru hospital discharge and re-admission within 30 days of discharge.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2014.
- Background: PubMed 12232567Elkayam 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.
- Background: PubMed 8989127Marcus 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.
- Background: PubMed 9573502Abraham 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.
- Background: PubMed 10400005Mills 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.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet M Simsic, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
A study testing Nesiritide in people with Heart Failure and Ventricular Dysfunction, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine pharmacokinetics and safety of nesiritide in children (time frame: study period - first 2 days stay in cardiac intensive care unit thru hospital discharge and re-admission within 30 days of discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00166010, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2014.