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Cardiac Biomarkers in Patients With Single Ventricle Physiology

Cardiac Biomarkers in Patients With Single Ventricle Physiology

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03678909
Enrollment
19
Registered
2018-09-20
Start date
2018-03-01
Completion date
2020-07-30
Last updated
2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease, Congenital Heart Disease, Cyanotic Congenital Heart Disease, Hypoplastic Left Heart

Keywords

Troponin, BNP, Biomarkers, Hypoplastic Left Heart, Norwood, DKS

Brief 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 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.

Interventions

PROCEDURENorwood Palliation / DKS / Damus-Kaye-Stansel procedure

Norwood Palliation / DKS / Damus-Kaye-Stansel procedure

Sponsors

Baylor College of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Months
Healthy volunteers
No

Inclusion criteria

Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate

Exclusion criteria

Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days

Design outcomes

Primary

MeasureTime frameDescription
Mortality3- 6 months depending on second stage procedureMortality up to anticipated Glenn Procedure

Secondary

MeasureTime frameDescription
NEC3- 6 months depending on second stage procedureIncidence of Necrotizing enterocolitis
Reintubation3- 6 months depending on second stage procedureIncidence of Reintubation
Cath intervention3- 6 months depending on second stage procedureIncidence of cath interventions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026