ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
Sponsor: University of Colorado, Denver
Listed as NCT03404258, this observational or N/A phase trial focuses on Endothelin and Metabolomics and remains ongoing. Sponsored by University of Colorado, Denver, it has been updated 15 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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.
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.
Status Flow
Change History
15 versions recorded-
May 4, 2026 — Present [daily]
Active Not Recruiting
Status: Recruiting → Active Not Recruiting
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Jan 2025 — May 2026 [monthly]
Recruiting
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Sep 2024 — Jan 2025 [monthly]
Recruiting
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Jul 2024 — Sep 2024 [monthly]
Recruiting
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Dec 2023 — Jul 2024 [monthly]
Recruiting
▶ Show 10 earlier versions
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Dec 2022 — Dec 2023 [monthly]
Recruiting
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Sep 2021 — Dec 2022 [monthly]
Recruiting
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Jan 2021 — Sep 2021 [monthly]
Recruiting
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Sep 2020 — Jan 2021 [monthly]
Recruiting
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Jul 2020 — Sep 2020 [monthly]
Recruiting
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May 2019 — Jul 2020 [monthly]
Recruiting
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Jun 2018 — May 2019 [monthly]
Recruiting
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Apr 2018 — Jun 2018 [monthly]
Recruiting
Phase: NA → None
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Mar 2018 — Apr 2018 [monthly]
Recruiting NA
Status: Not Yet Recruiting → Recruiting
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Feb 2018 — Mar 2018 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility 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.
Contact Information
- University of Colorado, Denver
For direct contact, visit the study record on ClinicalTrials.gov .