ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis

Metabolomics Clinical Trial

Official title:

ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03404258
• Other study ID #: 17-0832
• Status: Recruiting
• Start date: February 10, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Benjamin Frank, MD
• Phone: 720 777 1954
• Email: Benjamin.Frank[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 1 Month to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endothelin
• Metabolomics
• Pulmonary Vascular Resistance Abnormality
• Single-ventricle
• Superior Cavo-Pulmonary Anastomosis
• Univentricular Heart

Intervention

Other:
• Research Blood Sampling
Blood samples will be collected at specified time points and research assays will be performed.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in ET1 concentration between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.		48 hours post-operatively
Primary	Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.		48 hours post-operatively
Secondary	Association between ET1 concentration at pre-SCPA catheterization in study patients and clinical metrics of pre-operative pulmonary adequacy.		48 hours post-operatively
Secondary	Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy.		48 hours post-operatively