Congenital Heart DiseaseNCT00238810
Relationship of Brain Natriuretic Peptide (BNP) Levels to Cardiac Diagnosis, Operation Performed, Post-operative Course and Outcome
An observational study of Congenital Heart Disease, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
The purpose of this study is to assess brain natriuretic peptide levels to evaluate the relationship of those levels with the diagnosis of congenital cardiac disease, operation performed, post-operative course, and outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Nov 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with congenital heart defects
Who may be able to join
- Congenital heart defect
Who cannot join
- Patients without congenital heart defects
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Retrospective Evaluation of Serum B-type Natriuretic Peptide Hormone Levels in Post-operative Patients and the Relationship of BNP Levels to Cardiac Diagnosis, Operation Performed, Post-operative Course and Outcome
The purpose of this study is to assess brain natriuretic peptide levels to evaluate the relationship of those levels with the diagnosis of congenital cardiac disease, operation performed, post-operative course, and outcome.
Read the detailed description
Three types of natriuretic peptides (NP) have been isolated: atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and C-type natriuretic peptide (CNP). The NP family elicits a number of vascular, renal and endocrine effects that help to maintain blood pressure and extracellular fluid volume. These effects are mediated by the specific binding of NP to cell surface receptors that have been characterized, purified and cloned from cells of the vasculature, kidney, adrenal gland and brain. There are 3 subtypes of NP receptors: type A natriuretic peptide receptor (NPRA), type B natriuretic peptide receptor (NPRB), and type C natriuretic peptide receptor (NPRC). All 3 subtypes affect cellular second messenger activity. The literature currently does not define the levels of b-type natriuretic peptide (BNP) in children with congenital heart disease undergoing surgery.
The investigator wishes to perform a retrospective chart review to define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome. The investigator will collect the following information from the medical record:
- Laboratory: BNP levels, serum pH, lactic acid, Co-ox, CBC, Chemistry
- Diagnosis
- Surgical Procedure
- Incidence of re-operation
- Length of ICU Stay
- Length of Hospital Stay
- Complications
- Length of Ventilation (how many days on the ventilator)
- Medications
- Cross Clamp Time
- Bypass Time
- Echocardiogram data
- Cardiac Catheterization Data
- Vital Signs
- Monitored Hemodynamic Measures
- Final outcome (discharged or death)
- Conditions
- Congenital Heart Disease
- Keywords
- BNP, Pediatrics, Congenital heart disease, b-type natriuretic peptide
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome.
define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome.
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2005 (estimated)
- Study startApr 2005
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alecia Wang, MD, Principal investigator, Emory University Cardiac Fellow at Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238810
- Sponsor's protocol ID
- 05.068
- Status last verified
- Nov 2014
- First submitted
- 12 Oct 2005
- Last updated
- 2 Dec 2014
- Results posted
- No
Publications
Nakayama T. The genetic contribution of the natriuretic peptide system to cardiovascular diseases. Endocr J. 2005 Feb;52(1):11-21. doi: 10.1507/endocrj.52.11.
PubMed 15758553
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Serum B-type Natriuretic Peptide Hormone Levels in Post-operative Patients and the Relationship of BNP Levels to Cardiac Diagnosis, Operation Performed, Post-operative Course and Outcome
- ClinicalTrials.gov ID
- NCT00238810
- Acronym / sponsor ID
- 05.068
- Conditions
- Congenital Heart Disease
- Keywords
- BNP, Pediatrics, Congenital heart disease, b-type natriuretic peptide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Oct 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.
The purpose of this study is to assess brain natriuretic peptide levels to evaluate the relationship of those levels with the diagnosis of congenital cardiac disease, operation performed, post-operative course, and outcome.
Detailed description
Three types of natriuretic peptides (NP) have been isolated: atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and C-type natriuretic peptide (CNP). The NP family elicits a number of vascular, renal and endocrine effects that help to maintain blood pressure and extracellular fluid volume. These effects are mediated by the specific binding of NP to cell surface receptors that have been characterized, purified and cloned from cells of the vasculature, kidney, adrenal gland and brain. There are 3 subtypes of NP receptors: type A natriuretic peptide receptor (NPRA), type B natriuretic peptide receptor (NPRB), and type C natriuretic peptide receptor (NPRC). All 3 subtypes affect cellular second messenger activity. The literature currently does not define the levels of b-type natriuretic peptide (BNP) in children with congenital heart disease undergoing surgery.
The investigator wishes to perform a retrospective chart review to define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome. The investigator will collect the following information from the medical record:
- Laboratory: BNP levels, serum pH, lactic acid, Co-ox, CBC, Chemistry
- Diagnosis
- Surgical Procedure
- Incidence of re-operation
- Length of ICU Stay
- Length of Hospital Stay
- Complications
- Length of Ventilation (how many days on the ventilator)
- Medications
- Cross Clamp Time
- Bypass Time
- Echocardiogram data
- Cardiac Catheterization Data
- Vital Signs
- Monitored Hemodynamic Measures
- Final outcome (discharged or death)
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with congenital heart defects
Key inclusion criteria (1 listed)
- Congenital heart defect
Key exclusion criteria (1 listed)
- Patients without congenital heart defects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome.
Time frame: 9 years
define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Background: PubMed 15758553Nakayama T. The genetic contribution of the natriuretic peptide system to cardiovascular diseases. Endocr J. 2005 Feb;52(1):11-21. doi: 10.1507/endocrj.52.11.
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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.
Alecia Wang, MD principal investigator
Emory University Cardiac Fellow at Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Children's Healthcare of Atlanta at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome. (time frame: 9 years). 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 NCT00238810, which also lists 1 linked publication.
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 2 Dec 2014.