Chemical Block and Electrical Stimulation of the Carotid Body to Treat Refractory Hypertension

Last updated: January 26, 2021
Sponsor: Eric Albrecht
Overall Status: Trial Not Available

Phase

N/A

Condition

Vascular Diseases

Stress

Williams Syndrome

Treatment

N/A

Clinical Study ID

NCT02519868
CER 227-15
  • Ages 18-70
  • All Genders

Study Summary

High blood pressure, also referred to as hypertension, affects about 65 million people in the United States alone. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications. Recently, new evidence has demonstrated that the carotid body (CB) plays a role in essential refractory hypertension, possibly due to a deregulated, enhanced activity of this organ. Animal studies showed that CB de-afferentiation, through carotid sinus nerve denervation, leads to a long-term stable drop in blood pressure in spontaneously hypertensive rats. De-afferentiation may be performed either by injecting local anesthetics or by electrical stimulation. Both techniques are daily used in the operating theater to anesthetize nerves for a wide range of surgical procedures. We hypothesize that blocking CB with local anesthetics will result in a drop of the blood pressure in refractory hypertensive patients. We also want to test the idea that stimulating the CB with an electrical current will mislead the CB and will also result in a drop of the blood pressure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-70 years of age, inclusive;
  • blood pressure not controlled despite 3 different anti-hypertensive drugs;
  • minimal body weight of 70 kg.

Exclusion

Exclusion Criteria:

  • history of neck surgery or radiotherapy;
  • secondary hypertension;
  • contraindications to regional anesthesia (e.g., allergy to local anesthetics,coagulopathy, bleeding diathesis, malignancy or infection in the area);
  • pregnancy;
  • severe respiratory disease;
  • inability to understand the informed consent and demands of the study;
  • patient refusal.

Study Design

Study Start date:
August 01, 2015
Estimated Completion Date:
August 31, 2022

Study Description

High blood pressure, also referred to as hypertension, affects about 65 million people in the United States alone. Approximately 25 percent of people with hypertension cannot control their high blood pressure, despite the use of multiple medications.

Recently, new evidence has demonstrated that the carotid body (CB) plays a role in essential refractory hypertension, possibly due to a deregulated, enhanced activity of this organ. Animal studies showed that CB de-afferentiation, through carotid sinus nerve denervation, leads to a long-term stable drop in blood pressure in spontaneously hypertensive rats. It has been further shown that hypertonicity of the CB leads to a sympathetic hyper-excitation in SH rats and causes an increased vasomotor tone, which in turn contributes to hypertension.

The increased knowledge about the role of the CB in essential hypertension has lead to the development of an implantable (via open surgery) pulse generator, which lead to significant decrease in blood pressure at 12 months. One-year results from 13 patients showed a 39 mmHg average decrease in systolic blood pressure and a 26 mmHg average decrease in diastolic blood pressure in early reports. Beside, the procedure is invasive and requires surgery under general anesthesia.

De-afferentiation may be performed either by injecting local anesthetics or by electrical stimulation. Both techniques are daily used in the operating theater to anesthetize nerves for a wide range of surgical procedures.

We hypothesize that blocking CB with local anesthetics will result in a drop of the blood pressure in refractory hypertensive patients. We also want to test the idea that stimulating the CB with an electrical current will mislead the CB and will also result in a drop of the blood pressure. Preliminary results will shed some light on the mechanism of action of the CB in refractory hypertension and will open the way to new therapeutical approaches such as development of new implantable devices through a transcutaneous approach.

Connect with a study center

  • Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

    Lausanne, Vaud 1011
    Switzerland

    Site Not Available

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