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Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry (PPHNet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02249923
Recruitment Status : Recruiting
First Posted : September 26, 2014
Last Update Posted : August 12, 2022
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease
Pulmonary Vascular Disease Pulmonary Arterial Hypertension

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 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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry
Study Start Date : October 2014
Estimated Primary Completion Date : December 2030
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Pulmonary Arterial Hypertension


Outcome Measures
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Primary Outcome Measures :
  1. Time to clinical worsening [ Time Frame: 36 months ]
    Death


Secondary Outcome Measures :
  1. Escalation of Pulmonary Hypertension Therapy [ Time Frame: 36 months ]
    The addition of patients baseline medication therapy, this can include going from mono therapy to dual therapy, or dual therapy to triple therapy

  2. Right Heart Failure [ Time Frame: 36 months ]
    Elevated Right atrial pressure greater than 10 by right heart catheterization


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Day to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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, HIV, and use of anorexigens.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249923


Contacts
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Contact: Steven Abman, MD 303-881-9765 steven.abman@uanschutz.org
Contact: Robin Mascotti 303-724-6513 robin.mascotti@childrenscolorado.org

Locations
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United States, California
Stanford University Medical center Recruiting
Palo Alto, California, United States
Contact: Jeffrey Feinstein, MD       jeff.feinstein@stanford.edu   
Principal Investigator: Jeffrey Feinstein, MD         
University California San Francisco Recruiting
San Francisco, California, United States
Contact: Jeffrey Fineman, MD       jeff.fineman@ucsf.edu   
Principal Investigator: Jeffrey Fineman, MD         
United States, Colorado
Children's Hospital Colorado Completed
Aurora, Colorado, United States, 80045
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States
Contact: Mary Mullen, MD       Mary.Mullen@cardio.chboston.org   
Principal Investigator: Mary Mullen, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States
Contact: Erika Rosenzweig, MD       esb14@columbia.edu   
Principal Investigator: Erika Rosenzweig, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States
Contact: Catherine Avitabile, MD       AvitabileC@email.CHOP.EDU   
Principal Investigator: Brian Hanna, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States
Contact: Eric Austin, MD       eric.austin@Vanderbilt.edu   
Principal Investigator: Eric Austin, MD         
Canada, Alberta
University of Alberta Edmonton Recruiting
Edmonton, Alberta, Canada
Contact: Ian Adatia, MD       iadatia@ualberta.ca   
Principal Investigator: Ian Adatia, MD         
Sponsors and Collaborators
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital Colorado
Investigators
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Principal Investigator: Steven H Abman, MD Children's Hospital Colorado
Principal Investigator: David D Ivy, MD Children's Hospital Colorado
Principal Investigator: Kenneth D Mandl, MD Boston Children's Hospital, Harvard School of Medicine
Principal Investigator: Jeffrey Fineman, MD University California San Francisco
Principal Investigator: Jeffrey Feinstein, MD Stanford University
Principal Investigator: Ian Adatia, MD University of Alberta Edmonton
Principal Investigator: Catherine Avitabile, MD Children's Hospital of Philadelphia
Principal Investigator: Mary Mullen, MD Boston Children's Hospital
Principal Investigator: Eric Austin, MD Vanderbilt University Medical Center
Principal Investigator: Marc Natter, MD Boston Children's Hospital
Principal Investigator: Erika Rosenzweig, MD Columbia University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02249923    
Other Study ID Numbers: 14-0018
U01HL121518 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Pulmonary Arterial Hypertension (PAH)
Pulmonary Vascular Disease (PVD)
Registry
Pediatric
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases