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ROX Study for Hypertension - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and effectiveness of the ROX Coupler device to lower high blood pressure in patients with uncontrolled high blood pressure who are taking at least three high blood pressure medications.  

The ROX Coupler device is used during a cardiac catheterization to create a connection between your iliac artery and vein that will allow blood rich in oxygen to flow from the artery into the vein. This results in 1) oxygen rich blood returning to the lungs; and 2) lowering the resistance of flow in the blood vessels.

What is the Condition Being Studied?

Uncontrolled High Blood Pressure

Who Can Participate in the Study?

Adults age 22-85 who:
- Meet blood pressure requirements
- Are on a stable drug regimen for at least 3 months prior to screening (two high blood pressure medications from two different drug classes)
- Are taking a diuretic medication in addition to other blood pressure medications

For additional information about participating in this study, please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

- Go through three periods of participation: Screening, Procedure Day, and Follow Up.  

-- Screening Period: You will come to the clinic for consent and 3 separate screening visits.  
--- During these screening visits you will have several tests, including 24 hour blood pressure measurement, an echocardiogram, electrocardiogram, physical exam, and blood tests.

-- Procedure Day: You will have blood tests, a physical exam, and a cardiac catheterization procedure.
--- If the catheterization shows you are eligible, you will be randomized (like the flip of a coin) to continue the procedure with or without the ROX Coupler.  You will not know if you have received the ROX Coupler.
--- You will be observed overnight following the procedure and discharged home the next day.  

-- Follow up Period: You will be evaluated at the clinic week 1 and 1, 3, 6, 9, and 12 months following the procedure.    

Study Details

Full Title
A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects with Hypertension
Principal Investigator
Interventional Cardiologist
Protocol Number
IRB:PRO00083364
NCT:NCT02895386
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698