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

NCT02519868 | Withdrawn

• 1 other identifier: CER 227-15
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Neuromodulation; Local anaesthetics

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  15 minutes after electrical block and 15 minutes after chemical block

Secondary Outcomes (6)

• Heart rate

  15 minutes after each intervention

• Presence of paraesthesia

  During the procedure

• Presence of dyspnea

  During the procedure

• Presence of Claude-Bernard-Horner Syndrome

  During the procedure

• Presence of hoarseness

  During the procedure

Study Arms (1)

Experimental arm

EXPERIMENTAL

Patients will have both interventions: electrical stimulation followed by chemical stimulation

Device: Electrical block; Device: Chemical block

Interventions

Electrical block DEVICE

Nerve stimulator switched on at an intensity of 5 mA for 15 minutes, with the needle tip positioned close to the carotid bifurcation with the aid of the echography

Experimental arm

Chemical block DEVICE

Injection of lidocaine 1%, 15 mLs, with the needle tip positioned close to the carotid bifurcation, with the aid of the echography

Experimental arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eric Albrecht: lead

Study Sites (1)

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

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (4)

• Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.

  PMID: 18086926 BACKGROUND

• Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.

  PMID: 12493255 BACKGROUND

• McBryde FD, Abdala AP, Hendy EB, Pijacka W, Marvar P, Moraes DJ, Sobotka PA, Paton JF. The carotid body as a putative therapeutic target for the treatment of neurogenic hypertension. Nat Commun. 2013;4:2395. doi: 10.1038/ncomms3395.

  PMID: 24002774 BACKGROUND

• Alnima T, Scheffers I, De Leeuw PW, Winkens B, Jongen-Vancraybex H, Tordoir JH, Schmidli J, Mohaupt MG, Allemann Y, Kroon AA. Sustained acute voltage-dependent blood pressure decrease with prolonged carotid baroreflex activation in therapy-resistant hypertension. J Hypertens. 2012 Aug;30(8):1665-70. doi: 10.1097/HJH.0b013e3283551f10.

  PMID: 22728906 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eric Albrecht, PD Dr

  CHUV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Program Director, Regional Anaesthesia

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 11, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 29, 2021

Record last verified: 2021-01

Locations

CH (1)