ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
Running, not enrolling
Conditions studied: Single-ventricle, Pulmonary Vascular Resistance Abnormality, Superior Cavo-Pulmonary Anastomosis, Endothelin, Metabolomics
In brief
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 associated with decreased post-operative pulmonary blood flow in single ventricle patients undergoing superior cavo-pulmonary anastomosis (SCPA). The study will utilize a combined targeted and untargeted approach to both optimize translation of a promising existing biomarker and efficiently identify novel biomarkers and potential therapeutic targets in this population.
Key facts
- Study ID
- NCT03404258
- Run by
- University of Colorado, Denver
- People needed
- 50
- Starts
- 2018-02-10
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2026-05-01
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Children's Hospital Colorado — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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