Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension
NCT ID: NCT02610660
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
388 participants
OBSERVATIONAL
2015-08-31
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension)
NCT02576002
Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry
NCT02249923
Observational Study of Actigraphy in Pediatric Pulmonary Arterial Hypertension
NCT04745000
Latin American Pulmonary Hypertension Registry
NCT02570737
Actigraphy in Pediatric Pulmonary Hypertension
NCT02909608
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
3 Months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Association for Pediatric Pulmonary Hypertension
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dunbar Ivy, Prof
Role: STUDY_CHAIR
Association for Pediatric Pulmonary Hypertension
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford Children's Hospital
Palo Alto, California, United States
University of Colorado Denver School of Medicine, Children's Hospital Colorado
Aurora, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Emory University
Atlanta, Georgia, United States
Boston Children's Hospital
Boston, Massachusetts, United States
St Louis Children's Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University Children's Hospital
Nashville, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Royal Children's Hospital
Melbourne, , Australia
University of São Paulo
São Paulo, , Brazil
The Hospital for Sick Children
Toronto, Ontario, Canada
Fu Wai Hospital
Beijing, , China
Hospital Pediátrico La Misericordia
Bogotá, , Colombia
Université Paris Descartes
Paris, , France
University Children's Hospital Ulm
Ulm, , Germany
Institute of Cardiology
Budapest, , Hungary
Hadassah, Hebrew University Medical Center
Jerusalem, , Israel
University of Padova
Padua, , Italy
Toho Universit Omori Medical Center
Tokyo, , Japan
Keio University
Tokyo, , Japan
National Heart Institute
Mexico City, , Mexico
Beatrix Children's Hospital, University Medical Center Groningen
Groningen, , Netherlands
Children's Memorial
Warsaw, , Poland
King Fahd Armed Forces Hospital
Jeddah, , Saudi Arabia
The Queen Silvia's Children's Hospital
Gothenburg, , Sweden
Hôpital des Enfants
Geneva, , Switzerland
University Children's Hospital
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Webpage of the Association for Pediatric Pulmonary Hypertension
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TOPP-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.