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Active, not recruitingNCT03404258Updated May 1, 2026

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

An observational study in Single-ventricle, Pulmonary Vascular Resistance Abnormality and Superior Cavo-Pulmonary Anastomosis, sponsored by University of Colorado, Denver. Active, not recruiting at 1 site in United States. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University of Colorado, Denver · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
1 Month to 2 Years
Sex
All
01

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.

Read the 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.
02

Conditions studied

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

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03

Who can participate

Ages eligible
1 Month to 2 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Infants with single ventricle heart disease undergoing trans-catheter evaluation in anticipation of superior cavo-pulmonary anastomosis.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study Patients

    Infants between 1 month and 2 years of age undergoing evaluation for SCPA candidacy.

    Other: Research Blood Sampling

  • Control Patients

    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.

    Other: Research Blood Sampling

Interventions

  • OtherResearch Blood Sampling

    Blood samples will be collected at specified time points and research assays will be performed.

05

What researchers measure

Primary outcomes

  1. Difference in ET1 concentration between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.

    Time frame: 48 hours post-operatively

  2. Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.

    Time frame: 48 hours post-operatively

Secondary outcomes

  1. Association between ET1 concentration at pre-SCPA catheterization in study patients and clinical metrics of pre-operative pulmonary adequacy.

    Time frame: 48 hours post-operatively

  2. Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy.

    Time frame: 48 hours post-operatively

06

Study locations

1 site
  • Children's Hospital Colorado
    Denver, Colorado 80045, United States
07

References and documents

Publications

  • Frank BS, Khailova L, Silveira L, Mitchell MB, Morgan GJ, Hsieh EWY, DiMaria MV, Twite M, Klawitter J, Davidson JA. Proteomic profiling identifies key differences between inter-stage infants with single ventricle heart disease and healthy controls. Transl Res. 2021 Mar;229:24-37. doi: 10.1016/j.trsl.2020.10.001. Epub 2020 Oct 9. PubMed 33045409 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03404258
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Feb 10, 2018
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 1, 2026

Study contacts

Benjamin Frank, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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