Duke logo

OVATION for Pulmonary Hypertension - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the effectiveness of a study drug called iloprost as a vasodilator (a drug that opens up (dilates) blood vessels) during echocardiograms when compared to inhaled nitric oxide (the standard treatment). 

What is the Condition Being Studied?

Pulmonary hypertension

Who Can Participate in the Study?

Adults who are:
- Recently diagnosed with pulmonary hypertension
- Scheduled to have their first invasive hemodynamic assessment (cardiac catheterization) for pulmonary hypertension

Please contact the study team for more information about participating in the study.

Age Group
Adults

What is Involved?

As part of your routine medical care, you will
- Have an echocardiogram (an ultrasound of the heart) and be referred for vasodilator responsiveness invasive testing
- Be scheduled for a heart catheterization

If you choose to join the study, you will

- Have an echocardiogram with an inhaled study drug called iloprost within the 24 hours before your heart catheterization  

- Be followed by the Pulmonary Department every 3 months according to standard of care
- Have a variety of tests including 6 minute walk test, echocardiogram and blood work  

Data from your clinical visits at 3 and 12 month will be used in this study.   

Study Details

Full Title
Outpatient Vasodilator AssessmenT using Iloprost in PulmONary Hypertension (The OVATION Study)
Principal Investigator
Adult Congenital Heart Disease Specialist
Protocol Number
IRB:PRO00075840
NCT:NCT03044314
Phase
Phase IV
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698