Hypoplastic Left Heart SyndromeNCT00860327
Examining Developmental Changes in Heart Contractions of Children With Congenital Heart Defects
An observational study of Hypoplastic Left Heart Syndrome and Tetralogy of Fallot, run by Emory University at 1 site in United States.
Trial summary
Children who are born with heart defects undergo surgery when they are infants to correct the defects. However, many treatments that are used in pediatric heart patients were originally developed for adults and may not be the best option for children. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Hypoplastic Left Heart Syndrome, Tetralogy of Fallot
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2016
- 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 day to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Children undergoing surgery for repair of congenital heart defects.
Who may be able to join
- Newborns less than 1 week of age with hypoplastic left heart syndrome
- Infants between 3 to 12 months of age with tetralogy of Fallot
- Requires removal of ventricular tissue during surgery as part of the repair for a congenital heart defect
Who cannot join
- Children > 12 months of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University, Department of Pediatrics
Atlanta, Georgia, 30322
About this study
Official title: Excitation-contraction Coupling in Human Ventricle Development
Children who are born with heart defects undergo surgery when they are infants to correct the defects. However, many treatments that are used in pediatric heart patients were originally developed for adults and may not be the best option for children. This study will analyze tissue samples from newborns and infants undergoing surgery for heart defects to learn more about how a child's heart develops during the first year of life. This information may help to identify possible treatments geared specifically for the pediatric heart patient.
Read the detailed description
Congenital heart defects are abnormalities or problems with the structure of the heart that are present at birth. Examples of congenital heart defects include hypoplastic left heart syndrome, which is a condition that occurs when the left side of the heart does not develop completely, and tetralogy of Fallot, which is a condition that involves four specific types of structural defects within the heart. Many advances have been made in recent years in the field of pediatric heart surgery, and children who are born with congenital heart defects are now able to undergo heart surgery as infants to repair the defects. However, very little is known about the differences between how an infant's heart functions and how an adult's heart functions. Thus, most of the therapies that are used to treat children with heart defects were originally developed for adults and may not be the best option for infants and young children. The purpose of this study is to gain a better understanding of how the heart changes during a child's first year of life, from being a newborn less than 1 week old to being an infant 3 to 12 months old.
During surgical repair of congenital heart defects, tissue from the ventricular structures of the heart is sometimes removed as part of the surgery. In this study, researchers will examine ventricular tissue removed during the surgical procedures of newborns with hypoplastic left heart syndrome and infants with tetralogy of Fallot. Study researchers will compare the newborn and infant tissue samples in terms of their differences in excitation-contraction coupling, also referred to as contraction response. Excitation-contraction coupling in the heart is the process wherein electrical activity of the heart is translated into contraction of the heart muscle, which then results in pumping of the blood out to the body. Study researchers will also examine how calcium, which is required for heart contraction, flows in and out of heart cells to determine whether the process differs among newborns and infants. Acquiring data on both excitation-contraction coupling and the role of calcium is important because increasing the strength of heart contractions is a key component of treatment options for children with congenital heart defects.
This study has been granted a waiver of consent as de-identified tissue will be collected from waste samples. The number of participants represents the number of samples collected.
- Keywords
- Pediatric Heart Disease, Congenital Heart Disease, Congenital Heart Defects, Developmental Biology, Contractile Function
- Medical subject headings
- Hypoplastic Left Heart Syndrome, Tetralogy of Fallot, Heart Defects, Congenital
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 |
|---|---|---|
| Newborns | Newborns with hypoplastic left heart syndrome who are receiving a right ventricle to pulmonary artery shunt as first stage palliation. | |
| Infants | Infants who are undergoing complete repair for tetralogy of Fallot or similar pathology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium handling assay
Calcium handling will be assayed in tissue or cells by patch clamp, imaging or protein level measurement and will be done at the time the tissue is obtained.
Measured: At time of aquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startDec 2007
- Primary completionJun 2016
- Study completionJun 2016
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 Hypoplastic Left Heart SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Mary Wagner, Emory University
- Investigators
- Mary B. Wagner, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860327
- Sponsor's protocol ID
- IRB00007244
- Other IDs
- R01HL088488
- Status last verified
- Aug 2016
- First submitted
- 10 Mar 2009
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wiegerinck RF, Cojoc A, Zeidenweber CM, Ding G, Shen M, Joyner RW, Fernandez JD, Kanter KR, Kirshbom PM, Kogon BE, Wagner MB. Force frequency relationship of the human ventricle increases during early postnatal development. Pediatr Res. 2009 Apr;65(4):414-9. doi: 10.1203/PDR.0b013e318199093c.
PubMed 19127223
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excitation-contraction Coupling in Human Ventricle Development
- ClinicalTrials.gov ID
- NCT00860327
- Acronym / sponsor ID
- IRB00007244
- Keywords
- Pediatric Heart Disease, Congenital Heart Disease, Congenital Heart Defects, Developmental Biology, Contractile Function
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2007
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Mar 2009 (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 who are born with heart defects undergo surgery when they are infants to correct the defects. However, many treatments that are used in pediatric heart patients were originally developed for adults and may not be the best option for children. This study will analyze tissue samples from newborns and infants undergoing surgery for heart defects to learn more about how a child's heart develops during the first year of life. This information may help to identify possible treatments geared specifically for the pediatric heart patient.
Detailed description
Congenital heart defects are abnormalities or problems with the structure of the heart that are present at birth. Examples of congenital heart defects include hypoplastic left heart syndrome, which is a condition that occurs when the left side of the heart does not develop completely, and tetralogy of Fallot, which is a condition that involves four specific types of structural defects within the heart. Many advances have been made in recent years in the field of pediatric heart surgery, and children who are born with congenital heart defects are now able to undergo heart surgery as infants to repair the defects. However, very little is known about the differences between how an infant's heart functions and how an adult's heart functions. Thus, most of the therapies that are used to treat children with heart defects were originally developed for adults and may not be the best option for infants and young children. The purpose of this study is to gain a better understanding of how the heart changes during a child's first year of life, from being a newborn less than 1 week old to being an infant 3 to 12 months old.
During surgical repair of congenital heart defects, tissue from the ventricular structures of the heart is sometimes removed as part of the surgery. In this study, researchers will examine ventricular tissue removed during the surgical procedures of newborns with hypoplastic left heart syndrome and infants with tetralogy of Fallot. Study researchers will compare the newborn and infant tissue samples in terms of their differences in excitation-contraction coupling, also referred to as contraction response. Excitation-contraction coupling in the heart is the process wherein electrical activity of the heart is translated into contraction of the heart muscle, which then results in pumping of the blood out to the body. Study researchers will also examine how calcium, which is required for heart contraction, flows in and out of heart cells to determine whether the process differs among newborns and infants. Acquiring data on both excitation-contraction coupling and the role of calcium is important because increasing the strength of heart contractions is a key component of treatment options for children with congenital heart defects.
This study has been granted a waiver of consent as de-identified tissue will be collected from waste samples. The number of participants represents the number of samples collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newborns | – | –Newborns with hypoplastic left heart syndrome who are receiving a right ventricle to pulmonary artery shunt as first stage palliation. |
| Infants | – | –Infants who are undergoing complete repair for tetralogy of Fallot or similar pathology. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children undergoing surgery for repair of congenital heart defects.
Key inclusion criteria (3 listed)
- Newborns less than 1 week of age with hypoplastic left heart syndrome
- Infants between 3 to 12 months of age with tetralogy of Fallot
- Requires removal of ventricular tissue during surgery as part of the repair for a congenital heart defect
Key exclusion criteria (1 listed)
- Children > 12 months of age
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
Calcium handling assay
Time frame: At time of aquisition
Calcium handling will be assayed in tissue or cells by patch clamp, imaging or protein level measurement and will be done at the time the tissue is obtained.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Results publication: PubMed 19127223Wiegerinck RF, Cojoc A, Zeidenweber CM, Ding G, Shen M, Joyner RW, Fernandez JD, Kanter KR, Kirshbom PM, Kogon BE, Wagner MB. Force frequency relationship of the human ventricle increases during early postnatal development. Pediatr Res. 2009 Apr;65(4):414-9. doi: 10.1203/PDR.0b013e318199093c.
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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.
Mary B. Wagner, PhD principal investigator
Emory University
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 Hypoplastic Left Heart Syndrome and Tetralogy of Fallot, run by Emory University 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 3 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: stopped early, as of the sponsor's last update on 22 Aug 2016. 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 was stopped early. Results are not available in the source record.
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?
Calcium handling assay (time frame: At time of aquisition). 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 NCT00860327, 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 22 Aug 2016.