Examining blood flow and biomarkers in infants with heart defects undergoing surgery
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
This study is trying to see how certain substances in the blood affect blood flow in infants with heart defects who are having surgery, to help improve their care and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 1 Month to 2 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Denver, Colorado) |
| Trial ID | NCT03404258 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between endothelin-1 (ET1) levels, metabolic pathway activation, and pulmonary blood flow in infants with congenital heart disease undergoing superior cavo-pulmonary anastomosis (SCPA). It aims to identify biomarkers associated with pre-operative pulmonary vascular development and post-operative complications. The study will collect blood and urine samples at various time points, along with clinical and demographic data, to explore the impact of ET1 on pulmonary vascular resistance. The findings could lead to better understanding and management of pulmonary blood flow in this patient population.
Who should consider this trial
Good fit: Ideal candidates are infants aged 31 days to 2 years with congenital heart disease undergoing evaluation for SCPA.
Not a fit: Patients with a pulsatile source of pulmonary blood flow post-operatively or those weighing less than 4kg will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pre-operative assessments and post-operative outcomes for infants undergoing heart surgery.
How similar studies have performed: While the approach of examining ET1 and metabolic pathways in this context is novel, similar studies have shown promise in understanding pulmonary vascular resistance in congenital heart disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Denver, Colorado
- Children's Hospital Colorado — Denver, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Benjamin Frank, MD — University of Colorado, Denver
- Study coordinator: Benjamin Frank, MD
- Email: Benjamin.Frank@childrenscolorado.org
- Phone: 720 777 1954
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.