ClinicalTrials.gg
WithdrawnNCT02519868Updated Jan 29, 2021

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

An interventional study of Electrical block and Chemical block in Hypertension, sponsored by Eric Albrecht. Withdrawn at 1 site in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Eric Albrecht · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 120 studies in Hypertension with a site in Switzerland — 19 open to participants now, 23 under way, 1 of them phase 3. Hypertension · Switzerland.

Enrollment
95th of 96
0 · median 181
Started
2015
with 3 others
No phase
36 of 120
10 open now
Registered
72nd of 120
by date

Among the 120 studies in Hypertension with a site in Switzerland, this one is the 95th largest by enrollment of the 96 interventional ones, is one of 4 that started in 2015, is one of 36 with no phase, and was the 72nd registered.

By phase

120 studies; the count open now beside each. This study's row is marked.

No phasethis study36 · 10 open
Phase 333 · 1 open
Observational24 · 8 open
Phase 419 · 0 open
Phase 27 · 0 open
Phase 11 · 0 open

By the year they started

First in 1998; this study’s year is marked. 4 started in 2015.

Size and results

Median enrollment 181 across the 96 interventional studies, 309 across the 24 observational. Of the 91 that completed or were terminated, 17 (19%) have results posted.

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02

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.

Read the detailed 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.

03

Conditions studied

  • Hypertension

Browse trials for

Keywords

  • Neuromodulation
  • Local anaesthetics
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 criteria

Exclusion Criteria:

  • history of neck surgery or radiotherapy;
  • secondary hypertension;
  • to regional anesthesia (e.g., allergy to local anesthetics, coagulopathy, bleeding diathesis, or infection in the area);
  • pregnancy;
  • severe respiratory disease;
  • inability to understand the and demands of the study;
  • patient refusal.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Experimental arm

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

    Device: Electrical block · Device: Chemical block

Interventions

  • DeviceElectrical block

    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

  • DeviceChemical block

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

06

What researchers measure

Primary outcomes

  1. Blood pressure

    Time frame: 15 minutes after electrical block and 15 minutes after chemical block

Secondary outcomes

  1. Heart rate

    Time frame: 15 minutes after each intervention

  2. Presence of paraesthesia

    Time frame: During the procedure

  3. Presence of dyspnea

    Time frame: During the procedure

  4. Presence of Claude-Bernard-Horner Syndrome

    Time frame: During the procedure

  5. Presence of hoarseness

    Time frame: During the procedure

  6. Presence of hematoma

    Time frame: During the procedure

07

Study locations

1 site
  • Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
    Lausanne, Vaud 1011, Switzerland
08

References and documents

Publications

  • 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. Erratum In: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett]. PubMed 18086926 ↗
  • 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. Erratum In: Lancet. 2003 Mar 22;361(9362):1060. PubMed 12493255 ↗
  • 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. PubMed 24002774 ↗
  • 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. PubMed 22728906 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2015, a primary completion of Aug 2022 and a completion of Aug 2022. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2015
First posted
Aug 11, 2015
Start
Aug 2015
Primary completionEst.
Aug 2022
CompletionEst.
Aug 2022
Last update
Jan 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02519868
Lead sponsor
Eric Albrecht
Responsible party
Eric Albrecht (Program Director, Regional Anaesthesia, Centre Hospitalier Universitaire Vaudois) — Sponsor-investigator
First posted
Aug 11, 2015
Start date
Aug 2015
Primary completion
Aug 2022 (estimated)
Completion
Aug 2022 (estimated)
Last update
Jan 29, 2021

Study contacts

Eric Albrecht, PD Dr
principal investigator · CHUV

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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