Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Jeffrey Fineman, MD
Headshot of Jeffrey Fineman
Jeffrey Fineman

Description

Summary

Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.

Details

Pulmonary Hypertension (PH) is a syndrome characterized by vasoconstriction and abnormal growth and function of endothelial and smooth muscle cells and other components within the pulmonary vessels, which leads to elevation of the pulmonary artery pressure. PH may be idiopathic (primary) without any known cause. Some cases of PH are familial. PH may also be secondary to a specific disease process such as portal hypertension, congenital heart disease, chronic lung disease, thromboembolic disease, connective tissue disease, human immunodeficiency virus (HIV), and use of anorexigens. Left untreated, PH is often progressive and fatal. There is no cure for PH. Therapy focuses upon treatment of secondary causes if present, and reduction of the pulmonary artery pressure through medical therapy. There have been many new developments within the past few years in the management of patients with PH. While there is no cure for PH early detection and treatment are important for survival of patients. Limited data is available that describes the etiologies, clinical course and prognosis of pediatric pulmonary hypertension.

Objectives

Aim 1: Clinical Research

  1. To provide a mechanism to store information about newborns, infants and children with PH;
  2. To determine the incidence and natural history of the various etiologies of pediatric PH;
  3. To define the investigator current diagnostic and therapeutic approaches to the diverse conditions associated with pediatric PH;
  4. To determine the response of children with PH to chronic therapies.

Aim 2: Research Infrastructure To create a robust scalable data architecture, to combine traditional registry data, electronic Health Record (EHR), and PRO (Patient Reported Outcome) data in a single resource.

Aim 3: Informatics Address three classes of unanswered questions crucial for the characterization and management of PH, comparing the information value of registry vs. EHR vs. fused data across registry/EHR/PROs, in the domains of spectrum of PH comorbidities, PH indicators and endpoints of morbidity and mortality, and response to therapies in PH.

Keywords

Pulmonary Vascular Disease, Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH), Pulmonary Vascular Disease (PVD), Registry, Pediatric, Pulmonary Hypertension, Hypertension, Vascular Diseases

Eligibility

You can join if…

Open to people ages up to 21 years

  • The subject's age of onset of pulmonary hypertension must be prior to age 18 years
  • The person providing consent must be able to read either Spanish or English.
  • The subject (and/or parent/legal guardian) must be able to provide informed consent

You CAN'T join if...

Locations

  • University California San Francisco accepting new patients
    San Francisco California United States
  • Stanford University Medical center accepting new patients
    Palo Alto California United States

Lead Scientist at UCSF

  • Jeffrey Fineman, MD
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 246 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Colorado, Denver
ID
NCT02249923
Study Type
Observational [Patient Registry]
Participants
Expecting 1000 study participants
Last Updated