Tricuspid AtresiaBHFSVPNCT00571233
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
An observational study of Tricuspid Atresia and Hypoplastic Left Heart Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart. Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Unbalanced AV Canal
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jan 2015
- 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 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients presenting to the UCSF Pediatric Heart Center.
Who may be able to join
- Children with a structurally normal heart and a patent ductus arteriosus.
- Children with single ventricle physiology.
Who cannot join
- Children must not have chromosomal abnormalities. Small deletions, such as that which produces DiGeorge syndrome, are permissible.
- Children with acute intercurrent non-cardiac inflammatory illness (such as post-operative wound infection) are ineligible, as such conditions may cause elevated blood levels of the proteins under study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Heart Center, University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology
The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.
Read the detailed description
We will investigate whether levels of blood proteins in children with well-functioning hearts with one ("single") ventricle are similar to levels of these blood proteins in children with two ventricles. For children with hearts with a single ventricle, we will examine blood proteins at various levels of heart function. To assess blood protein levels, we will collect small (6 mL) samples of blood. Heart function will be determined by existing clinical scoring systems. Enrolled patients will receive an echocardiogram, which is a dynamic ultrasound picture of the beating heart.
- Keywords
- Single Ventricle, Congenital Heart Disease, Children, Fontan, Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Heart Failure, Biomarkers, Single ventricle physiology such as:, unbalanced AV canal, Interested in patients both before and after Fontan Surgery
- Medical subject headings
- Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Univentricular Heart, Heart Defects, Congenital, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Group one consists of children 1 month - 6 years old who have structurally normal hearts, no heart failure, and a patent ductus arteriosus (PDA). | |
| 2 | Group two consists of children 1 month - 6 years old who have single ventricle physiology. Children with and without heart failure may participate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart failure, as assessed by clinical scoring systems.
Measured: Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center
Secondary outcomes (1)
Echocardiographic indices.
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2011
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tricuspid AtresiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harold Bernstein, MD, PhD, Principal investigator, UCSF Pediatric Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571233
- Sponsor's protocol ID
- 2529
- Acronym
- BHFSVP
- Status last verified
- May 2015
- First submitted
- 5 Dec 2007
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Shah A, Feraco AM, Harmon C, Tacy T, Fineman JR, Bernstein HS. Usefulness of various plasma biomarkers for diagnosis of heart failure in children with single ventricle physiology. Am J Cardiol. 2009 Nov 1;104(9):1280-4. doi: 10.1016/j.amjcard.2009.06.046.
PubMed 19840577Lowenthal A, Shah A, Bernstein HS. Letter by Lowenthal et al regarding article, "BNP levels predict outcome in pediatric heart failure patients: post hoc analysis of the Pediatric Carvedilol Trial". Circ Heart Fail. 2010 Nov;3(6):e32; author reply e33. doi: 10.1161/CIRCHEARTFAILURE.110.958470. No abstract available.
PubMed 21081737Lowenthal A, Camacho BV, Lowenthal S, Natal-Hernandez L, Liszewski W, Hills NK, Fineman JR, Bernstein HS. Usefulness of B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide as biomarkers for heart failure in young children with single ventricle congenital heart disease. Am J Cardiol. 2012 Mar 15;109(6):866-72. doi: 10.1016/j.amjcard.2011.10.049. Epub 2011 Dec 22.
PubMed 22196786
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Biomarkers for Heart Failure in Children With Single Ventricle Physiology
- ClinicalTrials.gov ID
- NCT00571233
- Acronym / sponsor ID
- BHFSVP / 2529
- Keywords
- Single Ventricle, Congenital Heart Disease, Children, Fontan, Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Heart Failure, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Dec 2007 (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 determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.
Detailed description
We will investigate whether levels of blood proteins in children with well-functioning hearts with one ("single") ventricle are similar to levels of these blood proteins in children with two ventricles. For children with hearts with a single ventricle, we will examine blood proteins at various levels of heart function. To assess blood protein levels, we will collect small (6 mL) samples of blood. Heart function will be determined by existing clinical scoring systems. Enrolled patients will receive an echocardiogram, which is a dynamic ultrasound picture of the beating heart.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Group one consists of children 1 month - 6 years old who have structurally normal hearts, no heart failure, and a patent ductus arteriosus (PDA). |
| 2 | – | –Group two consists of children 1 month - 6 years old who have single ventricle physiology. Children with and without heart failure may participate. |
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients presenting to the UCSF Pediatric Heart Center.
Key inclusion criteria (2 listed)
- Children with a structurally normal heart and a patent ductus arteriosus.
- Children with single ventricle physiology.
Key exclusion criteria (2 listed)
- Children must not have chromosomal abnormalities. Small deletions, such as that which produces DiGeorge syndrome, are permissible.
- Children with acute intercurrent non-cardiac inflammatory illness (such as post-operative wound infection) are ineligible, as such conditions may cause elevated blood levels of the proteins under study.
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
Heart failure, as assessed by clinical scoring systems.
Time frame: Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center
1 secondary outcome
Echocardiographic indices.
Time frame: Cross-sectional
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 14 May 2015.
- Results publication: PubMed 19840577Shah A, Feraco AM, Harmon C, Tacy T, Fineman JR, Bernstein HS. Usefulness of various plasma biomarkers for diagnosis of heart failure in children with single ventricle physiology. Am J Cardiol. 2009 Nov 1;104(9):1280-4. doi: 10.1016/j.amjcard.2009.06.046.
- Results publication: PubMed 21081737Lowenthal A, Shah A, Bernstein HS. Letter by Lowenthal et al regarding article, "BNP levels predict outcome in pediatric heart failure patients: post hoc analysis of the Pediatric Carvedilol Trial". Circ Heart Fail. 2010 Nov;3(6):e32; author reply e33. doi: 10.1161/CIRCHEARTFAILURE.110.958470. No abstract available.
- Results publication: PubMed 22196786Lowenthal A, Camacho BV, Lowenthal S, Natal-Hernandez L, Liszewski W, Hills NK, Fineman JR, Bernstein HS. Usefulness of B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide as biomarkers for heart failure in young children with single ventricle congenital heart disease. Am J Cardiol. 2012 Mar 15;109(6):866-72. doi: 10.1016/j.amjcard.2011.10.049. Epub 2011 Dec 22.
- Usefulness of Various Plasma Biomarkers for Diagnosis of Heart Failure in Children with Single Ventricle PhysiologyLink provided by the sponsor.
- Letter by Lowenthal et al regarding article, "BNP levels predict outcome in pediatric heart failure patients: post hoc analysis of the Pediatric Carvedilol Trial"Link provided by the sponsor.
- Usefulness of B-Type Natriuretic Peptide and N-Terminal Pro-B-Type Natriuretic Peptide as Biomarkers for Heart Failure in Young Children With Single Ventricle Congenital Heart DiseaseLink provided by the sponsor.
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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.
Harold Bernstein, MD, PhD principal investigator
UCSF Pediatric Cardiology
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 Tricuspid Atresia and Hypoplastic Left Heart Syndrome, run by University of California, San Francisco 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 2 inclusion and 2 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 14 May 2015. 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?
Heart failure, as assessed by clinical scoring systems. (time frame: Cross-sectional. We will obtain blood samples and assess for heart failure (function) concurrently when patients present to the Pediatric Heart Center). 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 NCT00571233, which also lists 3 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 14 May 2015.