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

Last updated: December 6, 2024
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Research Blood Sampling

Clinical Study ID

NCT03404258
17-0832
  • Ages 1-2
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Congenital heart disease patients undergoing catheterization for pre-SPCA evaluationor undergoing SCPA without plans for cardiac catheterization (utilizing data from apreviously performed clinical catheterization).

  • All patients will have age from 31 days to 2 years.

Exclusion

Exclusion Criteria:

  • Patients who will remain post-op with a pulsatile source of pulmonary blood flow inaddition to the cavo-pulmonary anastomosis (so called "1.5 ventricle" repair) willbe excluded.

  • Due to limitations in acceptable sample blood volumes for research, patients withweight <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 medicationregimen.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Research Blood Sampling
Phase:
Study Start date:
February 10, 2018
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Children's Hospital Colorado

    Denver, Colorado 80045
    United States

    Active - Recruiting

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