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

NCT ID: NCT03404258

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-10

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Patients

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

Research Blood Sampling

Intervention Type OTHER

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

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.

Research Blood Sampling

Intervention Type OTHER

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

Interventions

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Research Blood Sampling

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin Frank, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Children's Hospital Colorado

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Benjamin Frank, MD

Role: CONTACT

Phone: 720 777 1954

Email: [email protected]

Jesse Davidson, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Benjamin S Frank, MD

Role: primary

Jesse A Davidson, MD

Role: backup

Benjamin S Frank, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33045409 (View on PubMed)

Other Identifiers

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17-0832

Identifier Type: -

Identifier Source: org_study_id