Ignite Creation Date:
2024-05-06 @ 3:14 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02249923
Status:
RECRUITING
Last Update Posted:
2022-08-12
First Post:
2014-09-10
Brief Title:
Pediatric Pulmonary Hypertension Network PPHNet Informatics Registry
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Pediatric Pulmonary Hypertension Network PPHNet Informatics Registry
Status:
RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPHNet
Brief 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
Detailed Description:
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 registryEHRPROs in the domains of spectrum of PH comorbidities PH indicators and endpoints of morbidity and mortality and response to therapies in PH
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 registryEHRPROs in the domains of spectrum of PH comorbidities PH indicators and endpoints of morbidity and mortality and response to therapies in PH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL121518 | NIH | None | httpsreporternihgovquickSearchU01HL121518 |