A major study on a new technology once billed as a potential breakthrough in the treatment of high blood pressure has been suddenly halted. Doctors say renal denervation does not work after all. Fletcher Allen Health Care was one of the sites involved in the clinical trial.
"We found through this research-- the most recent trial here, which is the largest, best study trial of renal denervation-- that it doesn't work," said Dr. Harry Dauerman, a FAHC/UVM cardiologist.
Doctors had high hopes that it would, based on data from Europe that the technology could potentially decrease hard-to-treat blood pressure significantly. It could have been a major breakthrough for a major public health threat worldwide. Hypertension puts millions at risk of heart disease, stroke and death.
"We thought that based on those trials we'd be able to drop people's blood pressure at least 20 points, and so this really highlights the importance of clinical trials here in the U.S.," Dauerman said.
It involved inserting a catheter in the femoral artery at the top of the leg, similar to a cardiac catheterization. But instead of heading to the heart, it branched off to both kidneys where renal nerves were burned with an energy source. Doctors wanted to know if the blocked impulses could drop blood pressure. But after a year of study they found it wasn't the case after all. Doctors say renal denervation offered no greater benefit than traditional drug therapies and lifestyle change. The nationwide trial was canceled late last week.
"It's halted around the entire country. There's nowhere in the United States right now you can go and get renal denervation," Dauerman said.
So, Dauerman says it's back to square one in the effort to treat hard-to-treat high blood pressure. For now, he says the best medicine is regular screening, diet and exercise changes, and proven drug therapies.
The six-month study involved 535 patients nationwide. The final results are brand new, released by the maker of the device last week. Researchers have not even had a chance yet to publish their data.
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