Uncontrolled HypertensionSCRATCH-HTNNCT05179343

SCRATCH-HTN Study: Evaluating Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Hypertensive Patients

A study testing Active AffeX-CT device in people with Uncontrolled Hypertension and High Blood Pressure, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a pilot, sham-controlled, double blind, single-site device clinical trial designed to evaluate the safety, acceptability and efficacy of non-invasive autonomic neuromodulation in a cohort of 63 adult patients with uncontrolled high blood pressure. Read more about this study

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Uncontrolled Hypertension, High Blood Pressure
What is being tested?: Active AffeX-CT device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Aug 2022to 8 Sep 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant has given written informed consent.
Participant has sufficient knowledge of the English language to be able understand the participant information sheet and trial materials including outcome assessments.
Participant is aged ≥18 years and <80 years at the time of screening visit.
Participant is taking between 1 to 4 antihypertensive medications (inclusive) at time of screening and baseline (randomisation) visit and is willing to adhere to no change in medication during the trial until end of the trial visit (visit 5). (NB. Participant on only one antihypertensive medication should be taking that medication for at least six weeks prior to the screening visit).
Participant has confirmed diagnosis of hypertension.
Participant meets BP criteria:

Show all 17Show fewer

24-hour ambulatory BP monitoring (ABPM) at either screening visit or baseline (randomisation) visit, with mean daytime SBP of ≥135 mmHg and <170 mmHg and mean daytime DBP of ≥85 mm Hg and <115 mmHg (N.B. By default, Ambulatory Blood Pressure Monitoring [ABPM] at screening visit will be used at baseline visit. However, if there has been an addition of new medication after participants screening visit, 24-hour ABPM must be repeated at baseline visit).
Participant has one or more of the following associated conditions:
Obesity: BMI >30 or waist circumference >94 cm (men) or > 80cm (women). (NB. For participants of South-East Asian/Chinese/Japanese origin these cut-offs are >90 cm (men) or >80 cm (women)).
Type 2 diabetes - controlled or sub-optimally controlled (HbA1c ≤8.5% or ≤69 mmol/mol) on diet and/ or medications except insulin.
Heart rate (average) ≥70 bpm at screening or baseline (randomisation) visit (measurement taken after 5 minutes of rest in a seated position and when finger probe has been placed for a minimum of 30 seconds thereafter) or a heart rate (average) ≥60 bpm at screening or baseline (randomisation) visit if the patient is taking beta-blocker medication.
HbA1c ≥42 mmol/mol or fasting blood glucose (if available) ≥5.6 mmo/L AND either low HDL cholesterol (≤1.03 mmol/L for men and ≤1.29 mmol/L for women) or high triglyceride (triglycerides ≥1.7 mmol/L)
Both low HDL cholesterol (≤1.03 mmol/L for men and ≤1.29 mmol/L for women) AND high triglyceride (triglycerides ≥1.7 mmol/L)
Diagnosed or known case of polycystic ovarian syndrome.
Female participants of child-bearing potential (all those below 55 years except if they are surgically sterile, meaning they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, or formally diagnosed by their doctors to be post-menopausal) must agree to use the acceptable methods of contraception from the time of consent until last follow up visit.
Participant is able to communicate satisfactorily with the Investigator and Investigation Site staff, and to participate in, and comply with all clinical study requirements.
Participants agrees to have all trial procedures performed and is able and willing to comply with all trial visits and protocol requirements.

Who cannot join

Participant is unable and unwilling to use the AffeX-CT device daily.
Participant has a small tragus (ie. the size or shape of the tragus is such that it doesn't allow the application of the ear-clips of the AffeX-CT device for a sustained period of time).
Participant has a piercing on the tragus of the ear.
Participant is diagnosed with atrial fibrillation or other form of cardiac arrhythmia
Participant is known to have chronic kidney disease (CKD) stage 3b or higher or had eGFR <45 ml/min/1.73 m2 in last three months prior to baseline (randomisation) visit.
Participant has type 1 diabetes mellitus.

Show all 22Show fewer

Participant has type 2 diabetes mellitus on Insulin or those on oral antidiabetic medications with poor glycaemic control defined as HbA1c above 8.5% (or >69 mmol/mol).
Participant has a history of falls or symptoms of orthostatic hypotension in the last 3 months prior to baseline (randomisation) visit.
Participant is pregnant, nursing or planning to become pregnant within the next 6 months.
Participant suffers from chronic pain and has taken anti-inflammatory drugs for two or more days per week over the last month prior to baseline (randomisation) visit.
Participant has clinically significant or symptomatic hypertension-mediated target organ damage such as severe heart failure with NYHA 4, end stage renal damage, medically diagnosed/imaging proven stroke, symptomatic peripheral vascular disease, or severe retinopathy.
Participant has a history of stable or unstable angina or had an acute coronary event within 3 months prior to baseline (randomisation) visit or had a myocardial infarction within the last six months of enrolment prior to baseline (randomisation) visit.
Participant has a history of renal denervation within last 1 year prior to baseline (randomisation) visit.
Participant has a therapeutic implantable electronic/electrical device such as pacemaker, implantable cardioverter-defibrillators (ICDs), implanted vagal stimulators.
Participant has history of hospitalization (> 24 hour) for heart failure, or cerebrovascular accidents, or history of stroke diagnosed based on imaging or evidence of specialist diagnosis or any other indirect evidence such as discharge summary or clinical letter (at any time in the past).
Participant has mean daytime ABPM pulse pressure ≥ 80 mmHg at screening or baseline (randomisation) visit.
Participant has a heart rate <50 bpm at screening or baseline (randomisation) visit (measurement taken after 5 minutes of rest in a seated position and when finger probe has been placed for a minimum of 30 seconds thereafter).
Participant has auricular dermatitis.
Participant has postural hypotension, defined as a fall > 20mmHg in SBP on standing at 3 minutes (compared with sitting).
Participant has a history of hospitalization for hypertensive emergency or urgency in the last six months of enrolment prior to baseline (randomisation) visit.
Participant is identified as unsuitable to participate by the CI/Co-Investigator(s) and/or Investigation site team for another reason (e.g., for other medical reasons, laboratory abnormalities, limited life expectancy, etc.).
Participants with history of epilepsy and are currently on anti-epileptic medication or those who are not on any anti-epileptic medication but have history of a seizure within last 10 years.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Barts Health NHS Trust
London, E1 1FR

Other trials in United Kingdom

About this study

Official title: Sham Controlled RCT Evaluating the Safety, Acceptability and Efficacy of Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Uncontrolled Hypertensive Patients: a Pilot Study

Read the detailed description

SCRATCH-HTN trial is a randomised sham-controlled study designed to evaluate the safety, acceptability, and efficacy of trans-cutaneous autonomic neurostimulation (tAN) in a cohort of uncontrolled medicated hypertensive patients.

SCRATCH-HTN trial is designed to test the hypothesis that tAN treatment is safe and acceptable to the patient, improves the control of blood pressure in hypertension and sense of well-being amongst those who are receiving the active treatment as compared to those on sham treatment.

The study will recruit 63 patients with systemic arterial hypertension (male and female aged ≥18 years) who are receiving between one and three oral antihypertensive medications and remain hypertensive with blood pressure (BP) above target levels detailed below in the eligibility criteria. The participants will be randomly allocated to the active (tAN) or sham (sham-tAN) arms of the trial on 2:1 basis, respectively.

The total treatment duration is 12 weeks. Self-administration of 30 min of tAN or sham stimulations once per day for the first two weeks, and then once every week for the rest of the trial period.

Conditions: Uncontrolled Hypertension, High Blood Pressure
Being tested: Active AffeX-CT device, Sham AffeX-CT device
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active AffeX-CT deviceDevice
(Trans-cutaneous Autonomic Neurostimulation) tAN treatment will be administered using AffeX-CT device (a device based on a totally TENS unit). AffeX device comprises of a battery-operated control unit, two electrode pairs arranged on ear clips and connected to the control unit with electrical leads. The AffeX device generates an electrical signal that is used to stimulate the nerves that naturally control the output from the sympathetic nervous system.
Sham AffeX-CT deviceDevice
Sham Totally TENS device. The device is identical to the active device used in the study, but its only purpose is to act as a placebo. The ear-clip electrodes have been modified so that the electric current is not transmitted to the participant.

Study groups in NCT05179343
Study group	Role	What they receive
Active arm	Experimental	Participants in this arm will receive the active AffeX-CT device. Receives: Device: Active AffeX-CT device
Sham arm	Sham comparator	Participants in this arm will receive the sham (inactive) AffeX-CT device. Receives: Device: Sham AffeX-CT device

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in average daytime ambulatory Systolic Blood Pressure (SBP) from baseline to the end of treatment.
Daytime SBP values will be obtained with 24hr ABPM
Measured: from baseline to 3 months

Secondary outcomes (13)

Change in average daytime ambulatory SBP and Diastolic Blood Pressure (DBP) from baseline and 1 month.
Daytime ambulatory SBP values will be obtained with 24hr ABPM
Measured: from baseline to 1 month
Change in average daytime ambulatory DBP from baseline to the end of treatment.
Daytime ambulatory DBP values will be obtained with 24hr ABPM
Measured: from baseline to 3 months
Controlled BP at the end of treatment defined as mean daytime ambulatory SBP<135 mmHg and mean daytime ambulatory DBP<85 mmHg.
Daytime ambulatory SBP and DBP will be obtained with 24hr ABPM
Measured: from baseline to 3 months
Change in average 24-hour ambulatory SBP and DBP from baseline to the end of treatment.
Daytime ambulatory SBP and DBP will be obtained with 24hr ABPM
Measured: from baseline to 3 months
Change in average office SBP and DBP from baseline to 1 month, and from baseline to the end of treatment (3 months).
Daytime ambulatory SBP and DBP will be obtained with a vital signs monitor
Measured: baseline to 1 month and baseline to 3 months
Change in average daytime ambulatory HR, and in average night-time ambulatory HR from baseline to the end of treatment.
Daytime and nigh-time ambulatory HR will be obtained with 24hr ABPM
Measured: from baseline to 3 months
Change in BP variability defined as the coefficient of variation (SD/mean) of 24-hour ambulatory SBP, and of within-visit office SBP from baseline to the end of treatment.
24hr ambulatory SBP will be obtained with 24hr ABPM
Measured: from baseline to 3 months
Change in Heart Rate (HR) variability defined as the coefficient of variation (SD/mean) of 24-hour ambulatory HR, and of within-visit office HR from baseline to the end of treatment.
24hr ambulatory HR will be obtained with 24hr ABPM
Measured: from baseline to 3 months
Occurrence of a serious adverse event (SAE), fatal or non-fatal, within 3 months.
SAEs will be collected through patient interviews, reporting and monitoring
Measured: from baseline to 3 months
The occurrence of a major cardiovascular event (MACE), including myocardial infarction (MI), stroke, and cardiovascular-related mortality within 3 months.
MACE will be collected through patient interviews, reporting and monitoring
Measured: from baseline to 3 months
Change in Quality of life between baseline and the end of the treatment (3 months) using the EuroQol Visual Analogue score (0-100), and the EuroQol 5 Dimension (EQ5D) quality of life (QoL) questions.
EQ-5D-5L questionnaire
Measured: from baseline to 3 months
Change in sleep quality between baseline and the end of the treatment using the Insomnia Severity Index (ISI), a 7-item questionnaire with each question allowing responses on a 5-point Likert scale from 0-4. Responses summed to give an overall score of 0
ISI questionnaires
Measured: from baseline to 3 months
Adherence to trial therapy, assessed as the proportion of days out of total days in follow-up when therapy was self-administered, and the average daily duration of self-administered therapy over the 3 months of follow-up (90 days).
Study log-book
Measured: from baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20228 Sep 2025

First posted5 Jan 2022
Study start1 Aug 2022
Primary completion8 Sep 2025
Study completion8 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Eligible participants will be randomised at the baseline visit to either the active (tAN) or sham (sham-tAN) device arm of the trial at a ratio 2:1 ratio.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05179343
Sponsor's protocol ID: 2358563
Acronym: SCRATCH-HTN
Status last verified: Nov 2025
First submitted: 16 Dec 2021
Last updated: 19 Nov 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: On publication of findings relevant anonymized dataset will be made available to benefit researchers with justifiable reasons

Publications

Markle W, M. Fisher, and R. Smego. Understanding Global Health. Economics and Global Health. 2007.
Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
PubMed 30165516
England PH. Health matters: preventing cardiovascular disease 2019.
Foundation BH. BHF Coronavirus and Heart & Circulatory Disease Statistics. 2020.
Egan BM, Kjeldsen SE, Grassi G, Esler M, Mancia G. The global burden of hypertension exceeds 1.4 billion people: should a systolic blood pressure target below 130 become the universal standard? J Hypertens. 2019 Jun;37(6):1148-1153. doi: 10.1097/HJH.0000000000002021.
PubMed 30624370
England PH. Hypertension prevalence estimates in England. 2017;2020.
England PH. Tackling high blood pressure From evidence into action. 2014.
Achelrod D, Wenzel U, Frey S. Systematic review and meta-analysis of the prevalence of resistant hypertension in treated hypertensive populations. Am J Hypertens. 2015 Mar;28(3):355-61. doi: 10.1093/ajh/hpu151. Epub 2014 Aug 25.
PubMed 25156625
Abegaz TM, Shehab A, Gebreyohannes EA, Bhagavathula AS, Elnour AA. Nonadherence to antihypertensive drugs: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Jan;96(4):e5641. doi: 10.1097/MD.0000000000005641.
PubMed 28121920
Carey RM, Calhoun DA, Bakris GL, Brook RD, Daugherty SL, Dennison-Himmelfarb CR, Egan BM, Flack JM, Gidding SS, Judd E, Lackland DT, Laffer CL, Newton-Cheh C, Smith SM, Taler SJ, Textor SC, Turan TN, White WB; American Heart Association Professional/Public Education and Publications Committee of the Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Genomic and Precision Medicine; Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Stroke Council. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association. Hypertension. 2018 Nov;72(5):e53-e90. doi: 10.1161/HYP.0000000000000084.
PubMed 30354828
Dahal K, Khan M, Siddiqui N, Mina G, Katikaneni P, Modi K, Azrin M, Lee J. Renal Denervation in the Management of Hypertension: A Meta-Analysis of Sham-Controlled Trials. Cardiovasc Revasc Med. 2020 Apr;21(4):532-537. doi: 10.1016/j.carrev.2019.07.012. Epub 2019 Jul 26.
PubMed 31420197
Gupta A, Prince M, Bob-Manuel T, Jenkins JS. Renal denervation: Alternative treatment options for hypertension? Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):51-57. doi: 10.1016/j.pcad.2019.12.007. Epub 2019 Dec 27.
PubMed 31884099
Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Lobo MD, Sharp ASP, Bloch MJ, Basile J, Wang Y, Saxena M, Lurz P, Rader F, Sayer J, Fisher NDL, Fouassier D, Barman NC, Reeve-Stoffer H, McClure C, Kirtane AJ; RADIANCE-HTN Investigators. Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial. Circulation. 2019 May 28;139(22):2542-2553. doi: 10.1161/CIRCULATIONAHA.119.040451. Epub 2019 Mar 17.
PubMed 30880441
Kandzari DE, Bohm M, Mahfoud F, Townsend RR, Weber MA, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, Cohen SA, Fahy M, Pilcher G, Kario K; SPYRAL HTN-ON MED Trial Investigators. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet. 2018 Jun 9;391(10137):2346-2355. doi: 10.1016/S0140-6736(18)30951-6. Epub 2018 May 23.
PubMed 29803589
Clancy JA, Mary DA, Witte KK, Greenwood JP, Deuchars SA, Deuchars J. Non-invasive vagus nerve stimulation in healthy humans reduces sympathetic nerve activity. Brain Stimul. 2014 Nov-Dec;7(6):871-7. doi: 10.1016/j.brs.2014.07.031. Epub 2014 Jul 16.
PubMed 25164906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
Recruiting
Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension
Hypertension
RecruitingPhase 2/3
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
Uncontrolled or Resistant Hypertension
Recruiting
SPYRAL GEMINI Pilot Study
Hypertension, Vascular Diseases
Recruiting
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Hypertension, Vascular Diseases

All Uncontrolled Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sham Controlled RCT Evaluating the Safety, Acceptability and Efficacy of Autonomic Neuromodulation Using Trans-cutaneous Vagal Stimulation in Uncontrolled Hypertensive Patients: a Pilot Study
ClinicalTrials.gov ID: NCT05179343
Acronym / sponsor ID: SCRATCH-HTN / 2358563
Conditions: Uncontrolled Hypertension, High Blood Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Queen Mary University of LondonUniversity, hospital or other
Collaborators: Health Innovation Oxford and Thames Valley (Oxford AHSN)
Study start: 1 Aug 2022 (actual)
Primary completion: 8 Sep 2025 (actual)
Study completion: 8 Sep 2025 (actual)
First posted: 5 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The total treatment duration is 12 weeks. Self-administration of 30 min of tAN or sham stimulations once per day for the first two weeks, and then once every week for the rest of the trial period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Eligible participants will be randomised at the baseline visit to either the active (tAN) or sham (sham-tAN) device arm of the trial at a ratio 2:1 ratio.

Arm	Type	Receives
Active arm	Experimental	Device: Active AffeX-CT deviceParticipants in this arm will receive the active AffeX-CT device.
Sham arm	Sham comparator	Device: Sham AffeX-CT deviceParticipants in this arm will receive the sham (inactive) AffeX-CT device.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Participant has given written informed consent.
Participant has sufficient knowledge of the English language to be able understand the participant information sheet and trial materials including outcome assessments.
Participant is aged ≥18 years and <80 years at the time of screening visit.
Participant is taking between 1 to 4 antihypertensive medications (inclusive) at time of screening and baseline (randomisation) visit and is willing to adhere to no change in medication during the trial until end of the trial visit (visit 5). (NB. Participant on only one antihypertensive medication should be taking that medication for at least six weeks prior to the screening visit).
Participant has confirmed diagnosis of hypertension.

Key exclusion criteria (22 listed)

Participant is unable and unwilling to use the AffeX-CT device daily.
Participant has a small tragus (ie. the size or shape of the tragus is such that it doesn't allow the application of the ear-clips of the AffeX-CT device for a sustained period of time).
Participant has a piercing on the tragus of the ear.
Participant is diagnosed with atrial fibrillation or other form of cardiac arrhythmia
Participant is known to have chronic kidney disease (CKD) stage 3b or higher or had eGFR <45 ml/min/1.73 m2 in last three months prior to baseline (randomisation) visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active AffeX-CT device(Trans-cutaneous Autonomic Neurostimulation) tAN treatment will be administered using AffeX-CT device (a device based on a totally TENS unit). AffeX device comprises of a battery-operated control unit, two electrode pairs arranged on ear clips and connected to the control unit with electrical leads. The AffeX device generates an electrical signal that is used to stimulate the nerves that naturally control the output from the sympathetic nervous system.	Device	Active arm
Sham AffeX-CT deviceSham Totally TENS device. The device is identical to the active device used in the study, but its only purpose is to act as a placebo. The ear-clip electrodes have been modified so that the electric current is not transmitted to the participant.	Device	Sham arm

Primary outcome

Change in average daytime ambulatory Systolic Blood Pressure (SBP) from baseline to the end of treatment.
Time frame: from baseline to 3 months
Daytime SBP values will be obtained with 24hr ABPM

13 secondary outcomes

Change in average daytime ambulatory SBP and Diastolic Blood Pressure (DBP) from baseline and 1 month.
Time frame: from baseline to 1 month
Change in average daytime ambulatory DBP from baseline to the end of treatment.
Time frame: from baseline to 3 months
Controlled BP at the end of treatment defined as mean daytime ambulatory SBP<135 mmHg and mean daytime ambulatory DBP<85 mmHg.
Time frame: from baseline to 3 months
Change in average 24-hour ambulatory SBP and DBP from baseline to the end of treatment.
Time frame: from baseline to 3 months
Change in average office SBP and DBP from baseline to 1 month, and from baseline to the end of treatment (3 months).
Time frame: baseline to 1 month and baseline to 3 months
Change in average daytime ambulatory HR, and in average night-time ambulatory HR from baseline to the end of treatment.
Time frame: from baseline to 3 months
Change in BP variability defined as the coefficient of variation (SD/mean) of 24-hour ambulatory SBP, and of within-visit office SBP from baseline to the end of treatment.
Time frame: from baseline to 3 months
Change in Heart Rate (HR) variability defined as the coefficient of variation (SD/mean) of 24-hour ambulatory HR, and of within-visit office HR from baseline to the end of treatment.
Time frame: from baseline to 3 months
Occurrence of a serious adverse event (SAE), fatal or non-fatal, within 3 months.
Time frame: from baseline to 3 months
The occurrence of a major cardiovascular event (MACE), including myocardial infarction (MI), stroke, and cardiovascular-related mortality within 3 months.
Time frame: from baseline to 3 months
Change in Quality of life between baseline and the end of the treatment (3 months) using the EuroQol Visual Analogue score (0-100), and the EuroQol 5 Dimension (EQ5D) quality of life (QoL) questions.
Time frame: from baseline to 3 months
Change in sleep quality between baseline and the end of the treatment using the Insomnia Severity Index (ISI), a 7-item questionnaire with each question allowing responses on a 5-point Likert scale from 0-4. Responses summed to give an overall score of 0
Time frame: from baseline to 3 months
Adherence to trial therapy, assessed as the proportion of days out of total days in follow-up when therapy was self-administered, and the average daily duration of self-administered therapy over the 3 months of follow-up (90 days).
Time frame: from baseline to 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
BackgroundMarkle W, M. Fisher, and R. Smego. Understanding Global Health. Economics and Global Health. 2007.
Background: PubMed 30165516Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement DL, Coca A, de Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen SE, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder RE, Shlyakhto E, Tsioufis C, Aboyans V, Desormais I; ESC Scientific Document Group. 2018 ESC/ESH Guidelines for the management of arterial hypertension. Eur Heart J. 2018 Sep 1;39(33):3021-3104. doi: 10.1093/eurheartj/ehy339. No abstract available.
BackgroundEngland PH. Health matters: preventing cardiovascular disease 2019.
BackgroundFoundation BH. BHF Coronavirus and Heart & Circulatory Disease Statistics. 2020.
Background: PubMed 30624370Egan BM, Kjeldsen SE, Grassi G, Esler M, Mancia G. The global burden of hypertension exceeds 1.4 billion people: should a systolic blood pressure target below 130 become the universal standard? J Hypertens. 2019 Jun;37(6):1148-1153. doi: 10.1097/HJH.0000000000002021.
BackgroundEngland PH. Hypertension prevalence estimates in England. 2017;2020.
BackgroundEngland PH. Tackling high blood pressure From evidence into action. 2014.
Background: PubMed 25156625Achelrod D, Wenzel U, Frey S. Systematic review and meta-analysis of the prevalence of resistant hypertension in treated hypertensive populations. Am J Hypertens. 2015 Mar;28(3):355-61. doi: 10.1093/ajh/hpu151. Epub 2014 Aug 25.
Background: PubMed 28121920Abegaz TM, Shehab A, Gebreyohannes EA, Bhagavathula AS, Elnour AA. Nonadherence to antihypertensive drugs: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Jan;96(4):e5641. doi: 10.1097/MD.0000000000005641.
Background: PubMed 30354828Carey RM, Calhoun DA, Bakris GL, Brook RD, Daugherty SL, Dennison-Himmelfarb CR, Egan BM, Flack JM, Gidding SS, Judd E, Lackland DT, Laffer CL, Newton-Cheh C, Smith SM, Taler SJ, Textor SC, Turan TN, White WB; American Heart Association Professional/Public Education and Publications Committee of the Council on Hypertension; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Genomic and Precision Medicine; Council on Peripheral Vascular Disease; Council on Quality of Care and Outcomes Research; and Stroke Council. Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association. Hypertension. 2018 Nov;72(5):e53-e90. doi: 10.1161/HYP.0000000000000084.
Background: PubMed 31420197Dahal K, Khan M, Siddiqui N, Mina G, Katikaneni P, Modi K, Azrin M, Lee J. Renal Denervation in the Management of Hypertension: A Meta-Analysis of Sham-Controlled Trials. Cardiovasc Revasc Med. 2020 Apr;21(4):532-537. doi: 10.1016/j.carrev.2019.07.012. Epub 2019 Jul 26.
Background: PubMed 31884099Gupta A, Prince M, Bob-Manuel T, Jenkins JS. Renal denervation: Alternative treatment options for hypertension? Prog Cardiovasc Dis. 2020 Jan-Feb;63(1):51-57. doi: 10.1016/j.pcad.2019.12.007. Epub 2019 Dec 27.
Individual participant dataSharing planned: No. On publication of findings relevant anonymized dataset will be made available to benefit researchers with justifiable reasons

Related trials for Uncontrolled Hypertension

Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
Recruiting
Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension
Hypertension
RecruitingPhase 2/3
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
Uncontrolled or Resistant Hypertension
Recruiting
SPYRAL GEMINI Pilot Study
Hypertension, Vascular Diseases
Recruiting
Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension
Hypertension, Vascular Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ajay K Gupta principal investigator

Queen Mary University of London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active AffeX-CT device in people with Uncontrolled Hypertension and High Blood Pressure, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average daytime ambulatory Systolic Blood Pressure (SBP) from baseline to the end of treatment. (time frame: from baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05179343, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.