Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 8/2/2018 |
| Start Date: | August 2015 |
| End Date: | December 2021 |
| Contact: | Fabrizio Canonaco, Dr |
| Email: | fabrizio.canonaco@peph-association.org |
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.
At least 200 of the enrolled patients will have a follow-up period of 3 years.
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.
At least 200 of the enrolled patients will have a follow-up period of 3 years.
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
We found this trial at
14
sites
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Aurora, Colorado 80045
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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