Inflammatory Biomarkers of Pediatric Pulmonary Hypertension | NCT03581695

Studies
Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

NCT03581695

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

May 4, 2026Actual

Enrollment

74Actual

Phase

Not provided

Conditions

Hypertension, Pulmonary

Interventions

Blood test

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 20, 2018Actual

Primary Completion Date

May 11, 2022Actual

Completion Date

Jul 1, 2024Actual

First Submitted Date

Jun 20, 2018

First Submission Date that Met QC Criteria

Jun 26, 2018

First Posted Date

Jul 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick ChildrenPrincipal Investigator

Lead Sponsor

The Hospital for Sick ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Other	Blood test	Congenital Heart Disease Healthy Controls Pulmonary Hypertension and Congenital Heart Disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of HGMB1	Measurement of HGMB1	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katherine Taylor	The Hospital for Sick Children	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006403	Hematologic Tests

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided