NCT03404258

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Feb 2018Dec 2027

First Submitted

Initial submission to the registry

January 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

February 10, 2018

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

9.9 years

First QC Date

January 11, 2018

Last Update Submit

April 27, 2026

Conditions

Single-ventriclePulmonary Vascular Resistance AbnormalitySuperior Cavo-Pulmonary AnastomosisEndothelinMetabolomics

Outcome Measures

Primary Outcomes (2)

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

    48 hours post-operatively

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

    48 hours post-operatively

Secondary Outcomes (2)

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

    48 hours post-operatively

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

    48 hours post-operatively

Study Arms (2)

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

Research Blood SamplingOTHER

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

Control PatientsStudy Patients

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Denver, Colorado, 80045, United States

Location

Related Publications (1)

  • 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.

    PMID: 33045409DERIVED

MeSH Terms

Conditions

Univentricular Heart

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Benjamin Frank, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 19, 2018

Study Start

February 10, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)