NCT02249923

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
2 countries

14 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2014Dec 2031

First Submitted

Initial submission to the registry

September 10, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
16.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

March 13, 2025

Status Verified

February 1, 2025

Enrollment Period

16.2 years

First QC Date

September 10, 2014

Last Update Submit

March 10, 2025

Conditions

Keywords

Pulmonary Arterial Hypertension (PAH)Pulmonary Vascular Disease (PVD)RegistryPediatric

Outcome Measures

Primary Outcomes (1)

  • Time to clinical worsening

    Time to clinical worsening for death, cardiac transplant, atrial septostomy, or Potts shunt.

    12 months

Secondary Outcomes (2)

  • Escalation of Pulmonary Hypertension Therapy

    36 months

  • Right Heart Failure

    36 months

Study Arms (1)

Pulmonary Arterial Hypertension

Eligibility Criteria

Age1 Day - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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 may not qualify if:

  • Diagnosed with pulmonary hypertension after age 18
  • Refusal to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Stanford University Medical Center

Palo Alto, California, United States

RECRUITING

University California San Francisco

San Francisco, California, United States

RECRUITING

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Johns Hopkins All Children's Heart Institute

St. Petersburg, Florida, United States

RECRUITING

Johns Hopkins Children's Center

Baltimore, Maryland, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, United States

RECRUITING

Columbia University Medical Center

New York, New York, United States

RECRUITING

Maria Fareri Children's Hospital at WMC Health/Westchester Medical Center

New York, New York, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

RECRUITING

Texas Children's

Houston, Texas, United States

NOT YET RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

RECRUITING

University of Alberta Edmonton

Edmonton, Alberta, Canada

RECRUITING

Related Publications (1)

  • Geva A, Gronsbell JL, Cai T, Cai T, Murphy SN, Lyons JC, Heinz MM, Natter MD, Patibandla N, Bickel J, Mullen MP, Mandl KD; Pediatric Pulmonary Hypertension Network and National Heart, Lung, and Blood Institute Pediatric Pulmonary Vascular Disease Outcomes Bioinformatics Clinical Coordinating Center Investigators. A Computable Phenotype Improves Cohort Ascertainment in a Pediatric Pulmonary Hypertension Registry. J Pediatr. 2017 Sep;188:224-231.e5. doi: 10.1016/j.jpeds.2017.05.037. Epub 2017 Jun 16.

Related Links

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Study Officials

  • 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
  • Roberta Keller, MD

    University California San Francisco

    PRINCIPAL INVESTIGATOR
  • Rachel Hopper, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Angela Bates, 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
  • Usha Krishnan, MD

    Columbia University

    PRINCIPAL INVESTIGATOR
  • Lynn A Sleeper, ScD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR
  • Erika Rosenzweig, MD

    Maria Fareri Children's Hospital at WMC Health/Westchester Medical Center

    PRINCIPAL INVESTIGATOR
  • Jenny Schramm, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Lewis Romer, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
  • Grace Freire, MD

    Johns Hopkins All Children's Heart Institute

    PRINCIPAL INVESTIGATOR
  • Stephanie Handler, MD

    Children's Hospital Wisconsin

    PRINCIPAL INVESTIGATOR
  • Nidhy Varghese, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR
  • Russel Hirsch, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR
  • Delphine Yung, MD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2014

First Posted

September 26, 2014

Study Start

October 1, 2014

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Last Updated

March 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations