NCT03581695

Brief Summary

To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 20, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

June 20, 2018

Last Update Submit

April 28, 2026

Conditions

Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (1)

  • Measurement of HGMB1

    Measurement of HGMB1

    1 day

Study Arms (3)

Pulmonary Hypertension and Congenital Heart Disease

Pulmonary Hypertension and Congenital Heart Disease

Other: Blood test

Congenital Heart Disease

Congenital Heart Disease

Other: Blood test

Healthy Controls

Healthy Controls

Other: Blood test

Interventions

Blood testOTHER

Blood test

Congenital Heart DiseaseHealthy ControlsPulmonary Hypertension and Congenital Heart Disease

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients of any age coming for cardiac catheterization and healthy controls coming for urology surgery.

You may qualify if:

  • patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart.

You may not qualify if:

  • active systemic infection
  • current active cancer
  • active cancer treatment
  • prior bone marrow transplant
  • prior solid organ transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Katherine Taylor

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

June 20, 2018

First Posted

July 10, 2018

Study Start

June 20, 2018

Primary Completion

May 11, 2022

Study Completion

July 1, 2024

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)