Clinical trial uses new device to treat severe hypertension


by JIM BERGAMO / KVUE News and photojournalist DAVID GARDNER

Bio | Email | Follow: @JimB_KVUE

Posted on December 13, 2012 at 7:34 PM

Updated Thursday, Dec 13 at 7:40 PM

AUSTIN -- A new, clinical trial going on at the Heart Hospital of Austin could be just the answer for patients suffering from difficult-to-treat hypertension or high blood pressure. It's actually a new take on an old procedure.

About 50 years ago it wasn't uncommon for doctors to perform major surgery to get the kidneys to help relieve hard-to-treat hypertension. The difficult surgery was risky, so doctors starting using medication instead. However, those also have complications. That has lead to a "back to the future" clinical trial that is far less invasive.

There's one thing on Russell Gillenwater's holiday wish list this year -- staying alive.

"We were basically thinking that I probably wouldn't see this Christmas," said Gillenwater.

Gillenwater, 52, who's been active all of his life says he can no longer read nor drive. For the last three years he's endured headaches, dizziness and blackouts -- all as a result of what doctors refer to as treatment-resistant hypertension or high blood pressure.

"The standard treatment for high blood pressure for years has been pills," said Frank Zidar, M.D., principal investigator and interventional cardiologist who practices at Heart Hospital of Austin. "If pills don't work, more pills."

"It was between nine to 11 pills," said Gillenwater.

"It's very frustrating for patients," said Zidar. "Every medicine has a side effect."  

So instead of pills, doctors started looking into a mechanical means to modulate the way the body controls the salt and water balance through the kidneys. An incorrect balance can lead to high blood pressure. They found it in a non-invasive catheter called the Symplicity HTN-3 -- a renal denervation device which sends energy pulses that allow doctors to regulate the output of nerves that line the walls of the arteries leading to the kidneys.

"The brain sends signals down through nerves to the kidneys through the kidney arteries, and it tells the kidneys what to do with holding on to salt or water to regulate your blood pressure," said Zidar. "If we can modify the input from the brain to the kidneys by effecting these nerves, or ablating these nerves, we can actually reduce blood pressure. "

While the Symplicity HTN-3 is already approved in Europe, it's still in a clinical trial in the U.S. The Heart Hospital of Austin is one of more than 50 centers across the country taking part in the six-month trial. Gillenwater was among the first to sign up.

"You've been locked down," he said. "You've lost your life. You think you are counting down your last few months right? Then all of a sudden somebody comes along and says maybe not. Maybe in 15 minutes I can give you all this back."

The Heart Hospital of Austin is looking for additional clinical participants. Those interested should be diagnosed with hypertension and be unable to control the illness even when taking three or more blood pressure medications.

For more information about the trial, click here.


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