ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
Launched by UNIVERSITY OF COLORADO, DENVER · Jan 11, 2018
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how certain biological markers relate to the development of blood vessels in the lungs of infants with a specific heart condition called single-ventricle heart disease. These infants often undergo a surgery known as superior cavo-pulmonary anastomosis (SCPA) to help improve blood flow. The researchers want to find out if they can identify any new markers or targets that could help improve outcomes for these patients, especially those who may have trouble with blood flow after surgery.
To be eligible for this study, babies aged between 31 days and 2 years who have congenital heart disease and are scheduled for SCPA surgery are invited to participate. However, babies who weigh less than 4 kilograms or those who will have a different type of surgery that involves maintaining some blood flow through the heart will not be included. Participants can expect to undergo evaluations that may include blood tests, and the information gathered may help improve care for future patients with similar conditions. This study is currently looking for participants, and all genders and backgrounds are welcome.
Gender
ALL
Eligibility 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.
About University Of Colorado, Denver
The University of Colorado, Denver, is a leading academic institution dedicated to advancing medical research and improving healthcare outcomes. With a strong emphasis on innovation and collaboration, the university conducts a diverse range of clinical trials aimed at addressing critical health challenges. Its research initiatives are supported by a multidisciplinary team of experts, state-of-the-art facilities, and a commitment to ethical standards and patient safety. By fostering partnerships with local and global communities, the University of Colorado, Denver, strives to translate scientific discoveries into meaningful advancements in clinical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Denver, Colorado, United States
Patients applied
Trial Officials
Benjamin Frank, MD
Principal Investigator
University of Colorado, Denver
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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