Trials / Recruiting
RecruitingNCT03404258
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- University of Colorado, Denver · Academic / Other
- Sex
- All
- Age
- 1 Month – 2 Years
- Healthy volunteers
- Not accepted
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.
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 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.
Conditions
- Single-ventricle
- Pulmonary Vascular Resistance Abnormality
- Superior Cavo-Pulmonary Anastomosis
- Endothelin
- Metabolomics
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Research Blood Sampling | Blood samples will be collected at specified time points and research assays will be performed. |
Timeline
- Start date
- 2018-02-10
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2018-01-19
- Last updated
- 2024-12-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03404258. Inclusion in this directory is not an endorsement.