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Clinical Trial 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 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.


Clinical Trial 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 vessel resistance leading to decreased pulmonary blood flow in patients undergoing SCPA. For enrolled patients, collected data will include: - 3 mL blood sample (x2) at pre-SCPA catheterization. - 3 mL blood samples at 2, 24, and 48 hours post-operative. - Urine sample pre-operatively and post-operatively - Collection of otherwise-discarded operative tissue sample from the pulmonary artery. - Collection of clinical data, demographic data, and results of routine, post-operative hemodynamic monitoring. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03404258
Study type Observational
Source University of Colorado, Denver
Contact Benjamin Frank, MD
Phone 720 777 1954
Email Benjamin.Frank@childrenscolorado.org
Status Recruiting
Phase
Start date February 10, 2018
Completion date December 31, 2025

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