Status:
RECRUITING
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
Lead Sponsor:
University of Colorado, Denver
Conditions:
Single-ventricle
Pulmonary Vascular Resistance Abnormality
Eligibility:
All Genders
1-2 years
Brief Summary
This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and complications associa...
Detailed Description
Overall Hypothesis: Endothelin-1 (ET1) and associated dysregulation of key metabolic pathways decrease pre-operative pulmonary blood vessel development and increase post-operative pulmonary blood vess...
Eligibility Criteria
Inclusion
- Congenital heart disease patients undergoing catheterization for pre-SPCA evaluation or undergoing SCPA without plans for cardiac catheterization (utilizing data from a previously performed clinical catheterization).
- All patients will have age from 31 days to 2 years.
Exclusion
- Patients who will remain post-op with a pulsatile source of pulmonary blood flow in addition to the cavo-pulmonary anastomosis (so called "1.5 ventricle" repair) will be excluded.
- Due to limitations in acceptable sample blood volumes for research, patients with weight \<4kg will be excluded.
- Patients will not be excluded on the basis of gender, ethnicity, genetic diagnosis, gestational age at birth, non-cardiac comorbidity, or pre-operative medication regimen.
Key Trial Info
Start Date :
February 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03404258
Start Date
February 10 2018
End Date
December 31 2025
Last Update
December 11 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Colorado
Denver, Colorado, United States, 80045