Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

Inflammatory Biomarkers of Pediatric Pulmonary Hypertension: a Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension, Pulmonary
• Intervention / Treatment: Other: Blood test

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Katherine Taylor; Phone Number: 4168137445; Email: katherine.taylor@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • Hospital for Sick Children
      • Contact: Katherine Taylor, MD; Phone Number: 4168138921; Email: katherine.taylor@sickkids.ca
      • Contact: Neil Goldenberg, MD PhD; Phone Number: 4168137445; Email: neil.goldenberg@sickkids.ca
      • Sub-Investigator: Benjamin Steinberg, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Congenital Heart Disease	Other: Blood test; Blood test
Healthy Controls	Other: Blood test; Blood test
Pulmonary Hypertension and Congenital Heart Disease	Other: Blood test; Blood test

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Katherine Taylor, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): May 19, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: 1000058900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No