Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension (NCT07207226) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension
France60 participantsStarted 2024-11-27
Plain-language 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. 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of Carotid-femoral PWV (Pulse wave velocity) by applanation tonometry using a Sphygmocor device
Timeframe: Baseline and Between 20 and 24 weeks after the baseline visit
Trial details
NCT IDNCT07207226
SponsorInstitut National de la Santé Et de la Recherche Médicale, France