ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
- Conditions
- Superior Cavo-Pulmonary AnastomosisPulmonary Vascular Resistance AbnormalitySingle-ventricleMetabolomicsEndothelin
- Interventions
- Other: Research Blood Sampling
- Registration Number
- NCT03404258
- Lead Sponsor
- University of Colorado, Denver
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Patients Research Blood Sampling Infants between 1 month and 2 years of age undergoing evaluation for SCPA candidacy. Control Patients Research Blood Sampling Infants between 3 months and 12 months of age with no known cardio-pulmonary disease, no active infection, and no known genetic abnormality undergoing elective surgery for a non-cardiac indication.
- Primary Outcome Measures
Name Time Method Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period. 48 hours post-operatively Difference in ET1 concentration between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period. 48 hours post-operatively
- Secondary Outcome Measures
Name Time Method Association between ET1 concentration at pre-SCPA catheterization in study patients and clinical metrics of pre-operative pulmonary adequacy. 48 hours post-operatively Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy. 48 hours post-operatively
Trial Locations
- Locations (1)
Children's Hospital Colorado
🇺🇸Denver, Colorado, United States