Hypoplastic Left HeartNCT03678909
Cardiac Biomarkers in Patients With Single Ventricle Physiology
An observational study of Hypoplastic Left Heart and Congenital Heart Disease, run by Baylor College of Medicine at 1 site in United States.
Trial summary
All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit… Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Hypoplastic Left Heart, Congenital Heart Disease, Cyanotic Congenital Heart Disease
- What is being tested?
- Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 30 Jul 2020
- 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 Up to 2 months
- All sexes
- No healthy volunteers
- Child
Study population: Neonate with Hypoplastic Left Heart Syndrome
Who may be able to join
- Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate
Who cannot join
- Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days
Trial locations and contacts
1 site in 1 country.
About this study
All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.
These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.
Read the detailed description
All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.
These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.
- Conditions
- Hypoplastic Left Heart, Congenital Heart Disease, Cyanotic Congenital Heart Disease, Cardiac Disease
- Being tested
- Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
- Keywords
- Troponin, BNP, Biomarkers, Hypoplastic Left Heart, Norwood, DKS
- Medical subject headings
- Hypoplastic Left Heart Syndrome, Heart Defects, Congenital, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norwood Palliation / DKS / Damus-Kaye-Stansel procedureProcedure or surgery
Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
| Study group | Role | What they receive |
|---|---|---|
| Hypoplastic Left Heart Disease | Patients with congenital hypoplastic left heart disease who will undergo surgical palliation with Norwood procedure or DKS or Damus-Kaye-Stansel procedure Receives: Procedure: Norwood Palliation / DKS / Damus-Kaye-Stansel procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality up to anticipated Glenn Procedure
Measured: 3- 6 months depending on second stage procedure
Secondary outcomes (3)
NEC
Incidence of Necrotizing enterocolitis
Measured: 3- 6 months depending on second stage procedure
Reintubation
Incidence of Reintubation
Measured: 3- 6 months depending on second stage procedure
Cath intervention
Incidence of cath interventions
Measured: 3- 6 months depending on second stage procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start1 Mar 2018
- Primary completion30 Jun 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoplastic Left HeartStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Anders, Baylor College of Medicine
- Investigators
- Marc M Anders, ND, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678909
- Sponsor's protocol ID
- H-42776
- Status last verified
- Jul 2020
- First submitted
- 16 Sep 2018
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is blinded to other study investigators.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Biomarkers in Patients With Single Ventricle Physiology
- ClinicalTrials.gov ID
- NCT03678909
- Acronym / sponsor ID
- H-42776
- Conditions
- Hypoplastic Left Heart, Congenital Heart Disease, Cyanotic Congenital Heart Disease, Cardiac Disease
- Keywords
- Troponin, BNP, Biomarkers, Hypoplastic Left Heart, Norwood, DKS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 20 Sep 2018 (actual)
- 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.
All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.
These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.
Detailed description
All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.
These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypoplastic Left Heart Disease | – | Procedure: Norwood Palliation / DKS / Damus-Kaye-Stansel procedurePatients with congenital hypoplastic left heart disease who will undergo surgical palliation with Norwood procedure or DKS or Damus-Kaye-Stansel procedure |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonate with Hypoplastic Left Heart Syndrome
Key inclusion criteria (1 listed)
- Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate
Key exclusion criteria (1 listed)
- Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days
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 |
|---|---|---|
| Norwood Palliation / DKS / Damus-Kaye-Stansel procedureNorwood Palliation / DKS / Damus-Kaye-Stansel procedure | Procedure or surgery | Hypoplastic Left Heart Disease |
Primary outcome
Mortality
Time frame: 3- 6 months depending on second stage procedure
Mortality up to anticipated Glenn Procedure
3 secondary outcomes
NEC
Time frame: 3- 6 months depending on second stage procedure
Reintubation
Time frame: 3- 6 months depending on second stage procedure
Cath intervention
Time frame: 3- 6 months depending on second stage procedure
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 3 Aug 2020.
- Individual participant dataSharing planned: No. The data is blinded to other study investigators.
Related trials for Hypoplastic Left Heart
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RecruitingObservational study
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
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Enrolling by invitation
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Active, not recruitingObservational study
Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type
Heart Defects
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.
Marc M Anders, ND principal investigator
Baylor College of Medicine
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 and Congenital Heart Disease, run by Baylor College of Medicine 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 3 Aug 2020. 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?
Mortality (time frame: 3- 6 months depending on second stage procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2020.