Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 3 Months - 18 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Exclusion Criteria:

- Patients belonging to Group 2 according to updated Nice clinical classification

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02610660
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Association for Pediatric Pulmonary Hypertension
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dunbar Ivy, Prof
Principal Investigator Affiliation Association for Pediatric Pulmonary Hypertension
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Australia, Brazil, Canada, China, Colombia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Saudi Arabia, Sweden, Switzerland, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Hypertension, Pulmonary
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford Children's Hospital, Palo Alto, California

Status

Address

Stanford Children's Hospital

Palo Alto, California, 94304

Aurora, Colorado

Status

Address

University of Colorado Denver School of Medicine, Children's Hospital Colorado

Aurora, Colorado, 80045

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010

Emory University, Atlanta, Georgia

Status

Address

Emory University

Atlanta, Georgia, 30322

Boston Children's Hospital, Boston, Massachusetts

Status

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

St Louis Children's Hospital, Saint Louis, Missouri

Status

Address

St Louis Children's Hospital

Saint Louis, Missouri, 63110

University of Nebraska Medical Center, Omaha, Nebraska

Status

Address

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Columbia University Medical Center, New York, New York

Status

Address

Columbia University Medical Center

New York, New York, 10032

Cincinnati, Ohio

Status

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Nashville, Tennessee

Status

Address

Vanderbilt University Children's Hospital

Nashville, Tennessee, 37232-9310

Texas Children's Hospital, Houston, Texas

Status

Address

Texas Children's Hospital

Houston, Texas, 77030

Primary Children's Hospital, Salt Lake City, Utah

Status

Address

Primary Children's Hospital

Salt Lake City, Utah, 84113

Seattle Children's Hospital, Seattle, Washington

Status

Address

Seattle Children's Hospital

Seattle, Washington, 98105

International Sites

Royal Children's Hospital, Melbourne, Australia

Status

Address

Royal Children's Hospital

Melbourne, , 3052

University of São Paulo, São Paulo, Brazil

Status

Address

University of São Paulo

São Paulo, , 05403-000

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Address

The Hospital for Sick Children

Toronto, Ontario, M5G 1XB

Fu Wai Hospital, Beijing, China

Status

Address

Fu Wai Hospital

Beijing, , 100037

Hospital Pediátrico La Misericordia, Bogota, Colombia

Status

Address

Hospital Pediátrico La Misericordia

Bogota, ,

Université Paris Descartes, Paris, France

Status

Address

Université Paris Descartes

Paris, , 75015

University Children's Hospital Ulm, Ulm, Germany

Status

Address

University Children's Hospital Ulm

Ulm, , 89075

Institute of Cardiology, Budapest, Hungary

Status

Address

Institute of Cardiology

Budapest, ,

Jerusalem, Israel

Status

Address

Hadassah, Hebrew University Medical Center

Jerusalem, , 91120

University of Padova, Padova, Italy

Status

Address

University of Padova

Padova, , 35127

Toho Universit Omori Medical Center, Tokyo, Japan

Status

Address

Toho Universit Omori Medical Center

Tokyo, , 1438541

Keio University, Tokyo, Japan

Status

Address

Keio University

Tokyo, , 160-8582

National Heart Institute, Mexico City, Mexico

Status

Address

National Heart Institute

Mexico City, , 14050

Groningen, Netherlands

Status

Address

Beatrix Children's Hospital, University Medical Center Groningen

Groningen, , 9700

Children's Memorial, Warsaw, Poland

Status

Address

Children's Memorial

Warsaw, , 04-730

King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia

Status

Address

King Fahd Armed Forces Hospital

Jeddah, , 23311

The Queen Silvia's Children's Hospital, Gothenburg, Sweden

Status

Address

The Queen Silvia's Children's Hospital

Gothenburg, , 41685

Hôpital des Enfants, Geneva, Switzerland

Status

Address

Hôpital des Enfants

Geneva, , 1211

University Children's Hospital, Zurich, Switzerland

Status

Address

University Children's Hospital

Zurich, , 8032

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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