Active — Not RecruitingNot Applicable

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

United States50 participantsStarted 2018-02-10

Plain-language 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.

Who can participate

Age range1 Month – 2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 48 hours post-operatively

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

Timeframe: 48 hours post-operatively

Trial details

NCT IDNCT03404258

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Single-ventricle trials

Plain-language summary

Who can participate

Age range1 Month – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 48 hours post-operatively

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

Timeframe: 48 hours post-operatively