Resistant HypertensionINSIDE-RHNCT07207226
Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension
A study testing Laser doppler vibrometry in people with Resistant Hypertension, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
According to WHO estimates, worldwide, 1.28 billion adults between the age of 30-79 years have hypertension. Furthermore, only 1 in 5 people with hypertension have it under control. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Laser doppler vibrometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2024to 25 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18-90 years of age in both sexes, diagnosed with resistant hypertension.
- - Resistance Hypertension defined as -
- Blood pressure at consultation > 140 and/or 90 mmHg and/or 24h-ABPM (Ambulatory Blood Pressure Assessment) and/or in Home blood pressure measurement (HBPM) > 130 and/or 80 mmHg despite taking three or more different classes of antihypertensive drugs at optimal doses, including a diuretic, on the day of screening irrespective of the BP on the day of the visit.
- Any office BP, ABPM or HBPM values in patients taking four or more different classes of antihypertensive drugs at optimal doses, including a diuretic.
- Patients scheduled for arterial stiffness assessment as a part of routine treatment.
- Patients eligible or affiliated with a social security scheme.
- Patients who provide written informed consent for participation.
Who cannot join
- - Inability to express consent to the study
- Persons subject to a judicial safeguard measure, under guardianship or curatorship.
- Patients with skin lesions (severe eczema, wounds, etc.) on the chest or neck that do not allow the application of the protective skin film on the area of interest; Allergies to the adhesive film.
- Subjects not affiliated with social security or an equivalent scheme.
- Linguistic incapacity or psychic refusal to read the information.
- Diseases carrying out a life -expectancy <1 year according to clinical judgment
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- Pregnant women (because of physiological hemodynamic changes in BP and stiffness during pregnancy)
- Arrhythmias: current AC/FA, high degree BAV.
- Persons subject to a period of exclusion for another research
- Foreseen inability to attend scheduled visits
Trial locations and contacts
1 site in 1 country.
About this study
According to WHO estimates, worldwide, 1.28 billion adults between the age of 30-79 years have hypertension. Furthermore, only 1 in 5 people with hypertension have it under control. In approximately 15% of the patients treated for hypertension, optimum blood pressure levels are not achieved even after the addition of 3-4 conventional anti-hypertensive drugs. These patients are diagnosed as resistant hypertensives. Resistant hypertension is associated with an increased risk of cardiovascular death, myocardial infarction, and stroke.
Hypertension is a chronic condition where arterial pressures are persistently elevated, leading to an increase in the pulsatile load on the arteries. This can result in structural and functional alterations in the arterial wall leading to an increase in 'arterial stiffness'.
Arterial stiffness is dependent on the mechanical load (blood pressure) and the material properties of the vessel wall. There is a vicious loop between hypertension and arterial stiffness, where hypertension may lead to alteration in the vascular structure and cause degradation of the elastic components of the vessel wall, and an increase in arterial stiffness can lead to higher blood pressure. An increase in arterial stiffness is associated with higher cardiovascular disease (CVD) risk, and patients with resistant hypertension are at a significantly higher risk of developing CVD. Measurement of carotid-femoral pulse wave velocity (PWV) is considered the gold standard for assessing arterial stiffness and has been recommended as a method to evaluate arterial stiffness as a part of routine care in patients with hypertension. The European Society of Hypertension (ESH) and the working group of the European Society of Cardiology (ESC) recommend its use for the evaluation of cardiovascular risk.
- Conditions
- Resistant Hypertension
- Being tested
- Laser doppler vibrometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser doppler vibrometryDevice
Non-invasive CARDIS Technology Demonstrator (CTD) device is a 2 x 6 beam laser Doppler vibrometer (LDV) for non-contact measurement of skin vibrations caused by underlying cardiac action. The CTD device is a split device with a master device and a slave device, which are connected to a data acquisition rack, which again is connected to a computer for signal processing, data presentation and data logging.
| Study group | Role | What they receive |
|---|---|---|
| Resistant Hypertension | Experimental | Participants with resistant hypertension defined as - - Blood pressure at consultation > 140 and/or 90 mmHg and/or 24h-ABPM (Ambulatory Blood Pressure Assessment) and/or in Home blood pressure measurement (HBPM) > 130 and/or 80 mmHg despite taking three or more different classes of antihypertensive drugs at optimal doses, including a diuretic, on the day of screening irrespective of the BP on the day of the visit.
- Any office BP, ABPM or HBPM values in patients taking four or more different classes of antihypertensive drugs at optimal doses, including a diuretic. Receives: Device: Laser doppler vibrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Carotid-femoral PWV (Pulse wave velocity) by applanation tonometry using a Sphygmocor device
The technique is non-invasive and will be made with the patient in a supine position. This measurement is repeated three times to ensure accuracy according to international recommendations
Measured: Baseline and Between 20 and 24 weeks after the baseline visit
Secondary outcomes (3)
Measurement of heart-carotide PWV (Pulse Wave Velocity) by LDV (Laser Doppler Vibrometer)
The measurement will be taken from the neck (carotid) to the groin (femoral) site
Measured: Baseline and Between 20 and 24 weeks after the baseline visit
Measurement of antihypertensive drug concentration
Drug levels will be tested in routine urine samples.
Measured: Baseline and Between 20 and 24 weeks after the baseline visit
Categorize adherence phenotype
Urine samples will be taken on a dried matrix
Measured: Baseline and Between 8 and 16 weeks after the baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start27 Nov 2024
- Primary completion27 Mar 2026
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Medtronic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207226
- Sponsor's protocol ID
- C23-84
- Other IDs
- IDRCB
- Acronym
- INSIDE-RH
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension
- ClinicalTrials.gov ID
- NCT07207226
- Acronym / sponsor ID
- INSIDE-RH / C23-84
- Conditions
- Resistant Hypertension
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Medtronic
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 3 Oct 2025 (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.
According to WHO estimates, worldwide, 1.28 billion adults between the age of 30-79 years have hypertension. Furthermore, only 1 in 5 people with hypertension have it under control. In approximately 15% of the patients treated for hypertension, optimum blood pressure levels are not achieved even after the addition of 3-4 conventional anti-hypertensive drugs. These patients are diagnosed as resistant hypertensives. Resistant hypertension is associated with an increased risk of cardiovascular death, myocardial infarction, and stroke.
Hypertension is a chronic condition where arterial pressures are persistently elevated, leading to an increase in the pulsatile load on the arteries. This can result in structural and functional alterations in the arterial wall leading to an increase in 'arterial stiffness'.
Arterial stiffness is dependent on the mechanical load (blood pressure) and the material properties of the vessel wall. There is a vicious loop between hypertension and arterial stiffness, where hypertension may lead to alteration in the vascular structure and cause degradation of the elastic components of the vessel wall, and an increase in arterial stiffness can lead to higher blood pressure. An increase in arterial stiffness is associated with higher cardiovascular disease (CVD) risk, and patients with resistant hypertension are at a significantly higher risk of developing CVD. Measurement of carotid-femoral pulse wave velocity (PWV) is considered the gold standard for assessing arterial stiffness and has been recommended as a method to evaluate arterial stiffness as a part of routine care in patients with hypertension. The European Society of Hypertension (ESH) and the working group of the European Society of Cardiology (ESC) recommend its use for the evaluation of cardiovascular risk.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resistant Hypertension | Experimental | Device: Laser doppler vibrometryParticipants with resistant hypertension defined as - - Blood pressure at consultation > 140 and/or 90 mmHg and/or 24h-ABPM (Ambulatory Blood Pressure Assessment) and/or in Home blood pressure measurement (HBPM) > 130 and/or 80 mmHg despite taking three or more different classes of antihypertensive drugs at optimal doses, including a diuretic, on the day of screening irrespective of the BP on the day of the visit. - Any office BP, ABPM or HBPM values in patients taking four or more different classes of antihypertensive drugs at optimal doses, including a diuretic. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients between 18-90 years of age in both sexes, diagnosed with resistant hypertension.
- - Resistance Hypertension defined as -
- Blood pressure at consultation > 140 and/or 90 mmHg and/or 24h-ABPM (Ambulatory Blood Pressure Assessment) and/or in Home blood pressure measurement (HBPM) > 130 and/or 80 mmHg despite taking three or more different classes of antihypertensive drugs at optimal doses, including a diuretic, on the day of screening irrespective of the BP on the day of the visit.
- Any office BP, ABPM or HBPM values in patients taking four or more different classes of antihypertensive drugs at optimal doses, including a diuretic.
- Patients scheduled for arterial stiffness assessment as a part of routine treatment.
Key exclusion criteria (10 listed)
- - Inability to express consent to the study
- Persons subject to a judicial safeguard measure, under guardianship or curatorship.
- Patients with skin lesions (severe eczema, wounds, etc.) on the chest or neck that do not allow the application of the protective skin film on the area of interest; Allergies to the adhesive film.
- Subjects not affiliated with social security or an equivalent scheme.
- Linguistic incapacity or psychic refusal to read the information.
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 |
|---|---|---|
| Laser doppler vibrometryNon-invasive CARDIS Technology Demonstrator (CTD) device is a 2 x 6 beam laser Doppler vibrometer (LDV) for non-contact measurement of skin vibrations caused by underlying cardiac action. The CTD device is a split device with a master device and a slave device, which are connected to a data acquisition rack, which again is connected to a computer for signal processing, data presentation and data logging. | Device | Resistant Hypertension |
Primary outcome
Measurement of Carotid-femoral PWV (Pulse wave velocity) by applanation tonometry using a Sphygmocor device
Time frame: Baseline and Between 20 and 24 weeks after the baseline visit
The technique is non-invasive and will be made with the patient in a supine position. This measurement is repeated three times to ensure accuracy according to international recommendations
3 secondary outcomes
Measurement of heart-carotide PWV (Pulse Wave Velocity) by LDV (Laser Doppler Vibrometer)
Time frame: Baseline and Between 20 and 24 weeks after the baseline visit
Measurement of antihypertensive drug concentration
Time frame: Baseline and Between 20 and 24 weeks after the baseline visit
Categorize adherence phenotype
Time frame: Baseline and Between 8 and 16 weeks after the baseline visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser doppler vibrometry in people with Resistant Hypertension, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. 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 France. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Measurement of Carotid-femoral PWV (Pulse wave velocity) by applanation tonometry using a Sphygmocor device (time frame: Baseline and Between 20 and 24 weeks after the baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.