Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry

Study Purpose

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.

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	1 Day - 21 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Diagnosed with pulmonary hypertension after age 18.

- Refusal to sign informed consent

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.	NCT02249923
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.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Steven H Abman, MDDavid D Ivy, MDKenneth D Mandl, MDJeffrey Fineman, MDJeffrey Feinstein, MDIan Adatia, MDCatherine Avitabile, MDMary Mullen, MDEric Austin, MDMarc Natter, MDErika Rosenzweig, MD
Principal Investigator Affiliation	Children's Hospital ColoradoChildren's Hospital ColoradoBoston Children's Hospital, Harvard School of MedicineUniversity California San FranciscoStanford UniversityUniversity of Alberta EdmontonChildren's Hospital of PhiladelphiaBoston Children's HospitalVanderbilt University Medical CenterBoston Children's HospitalColumbia University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	Canada, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Vascular Disease, Pulmonary Arterial Hypertension

Additional 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.#46; EHR vs.#46; 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.

Arms & Interventions

Arms

: Pulmonary Arterial Hypertension

Interventions

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 University Medical center, Palo Alto, California

Status

Recruiting

Address

Stanford University Medical center

Palo Alto, California,

Site Contact

Jeffrey Feinstein, MD

jeff.feinstein@stanford.edu

303-881-9765

University California San Francisco, San Francisco, California

Status