Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension
NCT ID: NCT07207226
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-11-27
2026-03-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Resistant Hypertension
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.
Laser doppler vibrometry
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.
Interventions
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Laser doppler vibrometry
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.
Eligibility Criteria
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Inclusion Criteria
* \- 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.
Exclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Locations
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Hopital Georges pompidou
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IDRCB
Identifier Type: REGISTRY
Identifier Source: secondary_id
C23-84
Identifier Type: -
Identifier Source: org_study_id
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