Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-21
SponsorNew York Medical College

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosed with pulmonary hypertension after age 18

Refusal to sign informed consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 1 trial group
Group A: Pulmonary Arterial Hypertension

Trial outcomes

Primary outcomes

1

Time to clinical worsening

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

Time frame
12 months

Secondary outcomes

1

Escalation of Pulmonary Hypertension Therapy

The addition of patients baseline medication therapy, this can include going from mono therapy to dual therapy, or dual therapy to triple therapy

Time frame
36 months
2

Right Heart Failure

Elevated Right atrial pressure greater than 10 by right heart catheterization

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York Medical College

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Janssen Pharmaceuticals

Collaborator