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Inflammatory Biomarkers of Pediatric Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03581695
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Taylor, The Hospital for Sick Children

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
Hypertension, Pulmonary Other: Blood test

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Study Type : Observational
Estimated 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 : June 20, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort 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




Primary Outcome Measures :
  1. Measurement of HGMB1 [ Time Frame: 1 day ]
    Measurement of HGMB1


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of any age coming for cardiac catheterization and healthy controls coming for urology surgery.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581695


Contacts
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Contact: Katherine Taylor 4168137445 katherine.taylor@sickkids.ca

Locations
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Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Katherine Taylor    4168138921    katherine.taylor@sickkids.ca   
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Katherine Taylor, MD    4168138921    katherine.taylor@sickkids.ca   
Contact: Neil Goldenberg, MD PhD    4168137445    neil.goldenberg@sickkids.ca   
Sub-Investigator: Benjamin Steinberg, MD PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Katherine Taylor The Hospital for Sick Children

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Responsible Party: Katherine Taylor, Staff Anesthesiologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03581695    
Other Study ID Numbers: 1000058900
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases