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NCT Number: NCT07207226

Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Resistant Hypertension

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Georges pompidou

Paris, Île-de-France Region, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • - 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
  • 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

Treatment and study plan

Laser doppler vibrometry

Device

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    The measurement will be taken from the neck (carotid) to the groin (femoral) site

  2. Measurement of antihypertensive drug concentration

    Time frame: Baseline and Between 20 and 24 weeks after the baseline visit

    Drug levels will be tested in routine urine samples.

  3. Categorize adherence phenotype

    Time frame: Baseline and Between 8 and 16 weeks after the baseline visit

    Urine samples will be taken on a dried matrix

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • Medtronic

Registry information

Acronym: INSIDE-RH

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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