High blood pressure (hypertension) is an increase in the force of blood against the arteries in the body. A blood pressure reading of 140/90 or higher indicates high blood pressure.
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Research + Clinical Trials
The REDUCE HTN: REINFORCE study is testing a new procedure that could treat high blood pressure. This procedure is called renal (kidney) denervation. The study will be evaluating patients that have high blood pressure when they do not take medications. The study will compare the blood pressure of people who undergo the study procedure (renal denervation) with the blood pressure of those who undergo a sham procedure (a renal angiogram that will not include the renal denervation). The study’s purpose is to collect data about the safety and effectiveness of this renal denervation (disabling of kidney nerves) treatment for patients with uncontrolled hypertension.
The Vessix™ Renal Denervation System consists of a catheter (a thin tube) and a radio frequency (RF) generator (power generator). The procedure involves the nerves that surround the blood vessel (artery) that supplies blood to the kidney (kidney artery). The generator sends energy through the kidney artery to disable the surrounding nerves. These nerves have a role in causing the kidneys to keep sodium (salt) in the body and in causing the amount of blood flowing into the filters in the kidney to be lower. These two things, among others, can then cause high blood pressure. By disabling these nerves, the Vessix system aims to reduce the amount of salt kept in the body and therefore reduce blood pressure in the body.
Renal denervation is not a treatment currently used for high blood pressure management in the U.S. The device is investigational in the United States. It is not approved by the U.S. FDA. The sponsor of this study is Boston Scientific Corporation.
The study will include 100 subjects at up to 20 hospitals in the US (about 20 of these subjects will be enrolled at Tufts Medical Center). About 67 people of the 100 total will get the renal denervation procedure (study group) and about 33 people will get a “sham” procedure (control group). People will be randomly selected to one or the other group. The doctor doing the procedure will know which group you are in when he is doing the procedure. Your Study Doctor will tell you whether you received the renal denervation procedure or the sham procedure at your 6 month follow-up visit. Until then, neither you nor your Study Doctor will know which procedure you received. The sham procedure is done to get data that is not influenced by knowing what procedure you received.