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Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Recruiting
CT.gov ID
NCT03581695
Collaborator
(none)
60
Enrollment
2
Locations
65.4
Anticipated Duration (Months)
30
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood test

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Inflammatory Biomarkers of Pediatric Pulmonary Hypertension: a Prospective Cohort Study
Actual Study Start Date :
Jun 20, 2018
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Pulmonary Hypertension and Congenital Heart Disease

Pulmonary Hypertension and Congenital Heart Disease

Other: Blood test
Blood test
Congenital Heart Disease

Congenital Heart Disease

Other: Blood test
Blood test
Healthy Controls

Healthy Controls

Other: Blood test
Blood test

Outcome Measures

Primary Outcome Measures

  1. Measurement of HGMB1 [1 day]

    Measurement of HGMB1

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
2 Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT03581695
Other Study ID Numbers:
  • 1000058900
First Posted:
Jul 10, 2018
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension

Study Results

No Results Posted as of May 19, 2022