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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02610660
Registration number
NCT02610660
Ethics application status
Date submitted
10/11/2015
Date registered
20/11/2015
Date last updated
13/04/2023
Titles & IDs
Public title
Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension
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Scientific title
Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension
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Secondary ID [1]
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TOPP-2
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Universal Trial Number (UTN)
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Trial acronym
TOPP-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension, Pulmonary
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Death
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Assessment method [1]
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Timepoint [1]
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Over registry run-time (5.5 years)
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Primary outcome [2]
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Transplantation
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Assessment method [2]
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Timepoint [2]
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Over registry run-time (5.5 years)
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Primary outcome [3]
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Adverse events
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Assessment method [3]
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Timepoint [3]
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Over registry run-time (5.5 years)
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Secondary outcome [1]
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Hospitalisation related to pulmonary arterial hypertension (PAH)
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Assessment method [1]
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Timepoint [1]
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Over registry run-time (5.5 years)
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Secondary outcome [2]
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Use/initiation of i.v./s.c. prostanoids
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Assessment method [2]
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Timepoint [2]
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Over registry run-time (5.5 years)
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Secondary outcome [3]
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Atrial septostomy
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Assessment method [3]
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Timepoint [3]
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Over registry run-time (5.5 years)
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Secondary outcome [4]
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Potts shunt
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Assessment method [4]
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Timepoint [4]
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Over registry run-time (5.5 years)
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Secondary outcome [5]
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Time to clinical worsening
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Assessment method [5]
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Various composites of above parameters
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Timepoint [5]
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Over registry run-time (5.5 years)
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Secondary outcome [6]
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Decline in 6-minute walk test (6MWT)
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Assessment method [6]
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Timepoint [6]
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Over registry run-time (5.5 years)
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Secondary outcome [7]
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Type of treatment
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Assessment method [7]
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Type of treatment (drug, mono/combination, administration route)
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Timepoint [7]
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Over registry run-time (5.5 years)
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Secondary outcome [8]
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Switch in treatment
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Assessment method [8]
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Timepoint [8]
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Over registry run-time (5.5 years)
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Secondary outcome [9]
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Escalation of treatment
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Assessment method [9]
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Timepoint [9]
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Over registry run-time (5.5 years)
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Secondary outcome [10]
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Reasons for treatment change
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Assessment method [10]
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Timepoint [10]
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Over registry run-time (5.5 years)
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Secondary outcome [11]
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Decline in WHO functional class
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Assessment method [11]
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Timepoint [11]
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Over registry run-time (5.5 years)
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Secondary outcome [12]
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Decline in Panama functional class
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Assessment method [12]
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Timepoint [12]
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Over registry run-time (5.5 years)
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Secondary outcome [13]
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Worsening of echocardiographic parameters (ECHO)
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Assessment method [13]
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Parameters encompass TAPSE and RV/LV dimension ratio
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Timepoint [13]
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Over registry run-time (5.5 years)
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Secondary outcome [14]
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Increase in Brain Natriuretic Peptide (BNP)
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Assessment method [14]
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Timepoint [14]
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Over registry run-time (5.5 years)
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Secondary outcome [15]
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Increase in N-terminal-proBNP (NT-proBNP)
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Assessment method [15]
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Timepoint [15]
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Over registry run-time (5.5 years)
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Eligibility
Key inclusion criteria
* Patient must be an incident patient, i.e.newly diagnosed with PH
* Age at time of diagnosis is at least 3 months and less than 18 years
* Patients must present with PH belonging to one of the following categories
* Group 1 according to updated Nice clinical classification
* Group 3 according to updated Nice clinical classification
* Group 4 according to updated Nice clinical classification
* Group 5 according to updated Nice clinical classification
* PH confirmed by heart catheterisation (HC)
* At HC, the patient must present with mean pulmonary arterial pressure (PAP) of at least 25 mmHg at rest, a pulmonary vascular resistance index (PVRi) equal to or below 3 Wood units*m^2 and mean pulmonary arterial wedge pressure (PAWP) below or equal to 15 mmHg
* In case of congenital heart disease (CHD) patients who had undergone palliative procedure or repair to close systemic to pulmonary shunt, the diagnosis of PH must have been confirmed by HC at least 6 months after surgery/palliative procedure took place
* For patients with PAH-CHD open shunt, only those considered not operable due to advanced pulmonary vascular disease are eligible
* Patients to be included into the registry, and/or their legal guardians, must give informed consent. Where applicable patients will be asked for their written assent
* Participating sites must agree to adhere to the recommendations of the WSPH 2015 Nice, Pediatric Taskforce.
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Minimum age
3
Months
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients belonging to Group 2 according to updated Nice clinical classification
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/12/2022
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Sample size
Target
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Accrual to date
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Final
388
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Children's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3052 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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District of Columbia
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Missouri
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Country [7]
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United States of America
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State/province [7]
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Nebraska
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Country [8]
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United States of America
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State/province [8]
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New York
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Country [9]
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United States of America
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State/province [9]
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Ohio
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Country [10]
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United States of America
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State/province [10]
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Tennessee
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Country [11]
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United States of America
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State/province [11]
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Texas
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Country [12]
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United States of America
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State/province [12]
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Utah
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Country [13]
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United States of America
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State/province [13]
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Washington
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Country [14]
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Brazil
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State/province [14]
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São Paulo
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Country [15]
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Canada
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State/province [15]
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Ontario
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Country [16]
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China
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State/province [16]
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Beijing
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Colombia
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State/province [17]
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Bogota
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Country [18]
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France
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State/province [18]
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Paris
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Germany
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State/province [19]
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Ulm
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Country [20]
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Hungary
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State/province [20]
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Budapest
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Country [21]
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Israel
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State/province [21]
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Jerusalem
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Italy
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State/province [22]
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Padova
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Japan
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State/province [23]
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Tokyo
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Country [24]
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Mexico
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State/province [24]
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Mexico City
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Netherlands
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State/province [25]
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Groningen
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Poland
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State/province [26]
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Warsaw
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Country [27]
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Saudi Arabia
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State/province [27]
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Jeddah
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Country [28]
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Sweden
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State/province [28]
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Gothenburg
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Country [29]
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Switzerland
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State/province [29]
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Geneva
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Country [30]
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Switzerland
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State/province [30]
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Zurich
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Funding & Sponsors
Primary sponsor type
Other
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Name
Association for Pediatric Pulmonary Hypertension
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood. Patients will undergo clinical assessments and receive standard medical care, as determined by treating physicians in their daily clinical practice. The TOPP-2 registry is specifically designed to capture the variables that have been proposed as treatment goals in PePH and the reasons for changes in treatment strategy. The TOPP-2 registry uses the new clinical classification of PH as outlined at the 5th World Symposium for Pulmonary Hypertension (WSPH) in Nice 2013 and includes new characterizations for children with PH. The registry is planned and implemented under the scientific leadership of the Association for Pediatric Pulmonary Hypertension (PePH), independently from the financial sponsors. All enrolled patients will have a follow-up period of 18 months.
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Trial website
https://clinicaltrials.gov/study/NCT02610660
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dunbar Ivy, Prof
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Address
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Association for Pediatric Pulmonary Hypertension
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02610660
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