Cardiac Biomarkers in Patients With Single Ventricle Physiology

Completed

• Conditions: Cyanotic Congenital Heart Disease; Hypoplastic Left Heart; Congenital Heart Disease; Cardiac Disease
• Interventions: Procedure: Norwood Palliation / DKS / Damus-Kaye-Stansel procedure

• Registration Number: NCT03678909
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-09-16
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-20
• Primary Completion: 2020-06-30
• Status Verified: 2020-07
• Study Completion: 2020-07-30
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypoplastic Left Heart Disease	Norwood Palliation / DKS / Damus-Kaye-Stansel procedure	Patients with congenital hypoplastic left heart disease who will undergo surgical palliation with Norwood procedure or DKS or Damus-Kaye-Stansel procedure

Primary Outcome Measures

Name	Time	Method
Mortality	3- 6 months depending on second stage procedure	Mortality up to anticipated Glenn Procedure

Secondary Outcome Measures

Name	Time	Method
NEC	3- 6 months depending on second stage procedure	Incidence of Necrotizing enterocolitis
Reintubation	3- 6 months depending on second stage procedure	Incidence of Reintubation
Cath intervention	3- 6 months depending on second stage procedure	Incidence of cath interventions

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States