Hypertension, PulmonaryNCT03581695
Inflammatory Biomarkers of Pediatric Pulmonary Hypertension
An observational study of Hypertension, Pulmonary, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Blood test
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2018to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients of any age coming for cardiac catheterization and healthy controls coming for urology surgery.
Who may be able to join
- -patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart.
Who cannot join
- active systemic infection
- current active cancer
- active cancer treatment
- prior bone marrow transplant
- prior solid organ transplant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hypertension, Pulmonary
- Being tested
- Blood test
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Blood test
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension and Congenital Heart Disease | Pulmonary Hypertension and Congenital Heart Disease Receives: Other: Blood test | |
| Congenital Heart Disease | Congenital Heart Disease Receives: Other: Blood test | |
| Healthy Controls | Healthy Controls Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of HGMB1
Measurement of HGMB1
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start20 Jun 2018
- Primary completion11 May 2022
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Taylor, The Hospital for Sick Children
- Investigators
- Katherine Taylor, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581695
- Sponsor's protocol ID
- 1000058900
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2018
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Biomarkers of Pediatric Pulmonary Hypertension: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03581695
- Acronym / sponsor ID
- 1000058900
- Conditions
- Hypertension, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension and Congenital Heart Disease | – | Other: Blood testPulmonary Hypertension and Congenital Heart Disease |
| Congenital Heart Disease | – | Other: Blood testCongenital Heart Disease |
| Healthy Controls | – | Other: Blood testHealthy Controls |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients of any age coming for cardiac catheterization and healthy controls coming for urology surgery.
Key inclusion criteria (1 listed)
- -patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart.
Key exclusion criteria (5 listed)
- active systemic infection
- current active cancer
- active cancer treatment
- prior bone marrow transplant
- prior solid organ transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testBlood test | Other | Congenital Heart Disease, Healthy Controls, Pulmonary Hypertension and Congenital Heart Disease |
Primary outcome
Measurement of HGMB1
Time frame: 1 day
Measurement of HGMB1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Taylor principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, Pulmonary, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of HGMB1 (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.