Jeffrey A. Feinstein, MD, MPH
Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension (TOPP)
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of the TOPP registry is to study the natural history of pulmonary hypertension (PH) in children and adolescents. The study focuses on diagnosis and disease management in real world clinical settings.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
Phase:
N/AEligibility
Ages Eligible for Study:
3 months to 18 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
All pediatric patients with pulmonary hypertension (PH) who:
- at the time of diagnosis >=3 months and <=18 years of age
- have been diagnosed with PH on or after January 1, 2001
- belong to at least one of the following categories:
* WHO Group 1 (PAH), including congenital heart disease with residual PH following surgery, with no residual left side obstruction
* WHO Group 3
* WHO Group 4
* WHO Group 5
- must have their PH confirmed by heart catheterization, with PAP mean >=25 mm Hg at rest (or >=30 mm Hg upon exercise), PVRi >=3 Wood units, and PCWP mean <=12 mm Hg
Key Exclusion Criteria:
Pediatric patients diagnosed with pulmonary hypertension belonging to WHO Group 2;
patients referred to a site for diagnosis only without anticipated follow-up at the site;
patients who underwent interventional procedure/surgery for closure or patient closure of systemic to pulmonary shunt(s), nor patients who underwent palliative pulmonay artery banding, unless PH still persists.
Additional Study Details
Official Title:
Tracking Outcomes and Practice in Pediatric Pulmonary Hypertension (TOPP)Anticipated start date:
4/1/2008Lead Sponsor:
Association in Pediatric Pulmonary Hypertension (PePH)Collaborator(s):
- International Multi-Center Registry
Investigator(s):
Study Type:
ObservationalPurpose:
NOTNEEDEDDuration:
LongitudinalSelection:
Defined PopulationTiming:
ProspectiveTotal Number to be Enrolled:
450Total Number to be Enrolled at Stanford:
50More Information
Secondary ID(s):
- IRB # 11920
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
3/17/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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