Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry

  • STATUS
    Recruiting
  • End date
    Dec 10, 2031
  • participants needed
    1000
  • sponsor
    University of Colorado, Denver
Updated on 10 July 2021
hypertension

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.

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 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.

Details
Condition Pulmonary Arterial Hypertension, Pulmonary Vascular Disease
Clinical Study IdentifierNCT02249923
SponsorUniversity of Colorado, Denver
Last Modified on10 July 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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