About the Study
Kids MoD PAH is a research study for kids with pulmonary hypertension (PAH). PAH is when your body has a hard time getting the right amount of blood flow to your lungs.
The Kids MoD PAH study is looking at whether using 2 medicines (sildenafil + bosentan) together is better than using 1 medicine (sildenafil) by itself. We want to learn which works best as a first treatment for infants and children.
These medicines are FDA-approved and used by doctors to care for children with PAH.
JHM IRB Protocol: #IRB00300590
Principal Investigator: Lewis H Romer, MD
Regular PAH Medical Care
Your child:
- will take medicines to treat PAH
- will have clinic visits every 3 months
- will have regular echocardiogram (echo) ultrasounds and lab tests
- may have additional labwork
What happens if my child joins?
If your child joins the study, they will be placed into 1 of 2 regular medical treatment groups:
Group 1 — Take sildenafil
Group 2 — Take sildenafil + bosentan
Study Activities
- keep medication diary on mobile app
- wear study-supplied watch to measure activity level
- answer questions about how your child is feeling
- may have some additional lab tests
- study team will check in with you by phone between clinic visits
Frequently Asked Questions
Is there a cost?
Your family’s insurance will be billed for all costs that are part of your child’s regular medical care, including your child’s PAH medicine.
There are no additional costs for being in the study.
What are the potential benefits and risks?
Your child may benefit from the most advanced follow-up available to track how well the PAH medicines are working for them.
As with any research study, there is the risk that your child’s personal information could be shared outside the study team. We will do everything we can to keep your child’s and your family’s information private.
Why is this study important?
Although we know what works best for adults with pulmonary arterial hypertension (PAH), we recognize that medical treatment for adults and children can be different.
The Kids MoD PAH Study could help us learn how to best treat kids recently diagnosed with PAH.
This research study is led by members of PPHNet. This is a dedicated group of hospitals and doctors whose mission is to improve health and quality of care for children with PAH.
Interested in learning more?
Get in touch
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JHM IRB Protocol
#IRB00300590
Principal Investigator
Lewis H Romer, MD
Led by investigators from
- Johns Hopkins Medicine
- Duke University School of Medicine
- New York Medical College
- Colorado University School of Medicine
- PPHNet
Funded by
National Heart, Lung, and Blood Institute (NHLBI)
