ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 2 |
| Updated: | 4/17/2018 |
| Start Date: | February 10, 2018 |
| End Date: | December 1, 2020 |
| Contact: | Benjamin Frank, MD |
| Email: | Benjamin.Frank@childrenscolorado.org |
| Phone: | 720 777 1954 |
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
Denver, Colorado 80045
Principal Investigator: Benjamin S Frank, MD
Phone: 720-777-6820
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