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Trial record 3 of 27 for:    Recruiting, Active, not recruiting, Enrolling by invitation Studies | Pulmonary Hypertension | Canada

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

Tracking Information
First Submitted Date June 20, 2018
First Posted Date July 10, 2018
Last Update Posted Date July 5, 2019
Actual Study Start Date June 20, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2018)
Measurement of HGMB1 [ Time Frame: 1 day ]
Measurement of HGMB1
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Inflammatory Biomarkers of Pediatric Pulmonary Hypertension
Official Title Inflammatory Biomarkers of Pediatric Pulmonary Hypertension: a Prospective Cohort Study
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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood samples
Sampling Method Non-Probability Sample
Study Population Patients of any age coming for cardiac catheterization and healthy controls coming for urology surgery.
Condition Hypertension, Pulmonary
Intervention Other: Blood test
Blood test
Study Groups/Cohorts
  • Pulmonary Hypertension and Congenital Heart Disease
    Pulmonary Hypertension and Congenital Heart Disease
    Intervention: Other: Blood test
  • Congenital Heart Disease
    Congenital Heart Disease
    Intervention: Other: Blood test
  • Healthy Controls
    Healthy Controls
    Intervention: Other: Blood test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Katherine Taylor 4168137445 katherine.taylor@sickkids.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03581695
Other Study ID Numbers 1000058900
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Katherine Taylor, The Hospital for Sick Children
Study Sponsor The Hospital for Sick Children
Collaborators Not Provided
Investigators
Principal Investigator: Katherine Taylor The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date July 2019