NCT07207226

Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-11-27
• Primary completion: 2026-03-27
• Completion: 2026-03-27
• First posted: 2025-10-03
• Last updated: 2025-10-03

Locations

1 site across 1 country: France