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Arterial Stiffness as a Tool to Investigate Adherence in Resistant Hypertension

Study acronym: INSIDE-RH
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Primary completion date changed from estimate of Jul 27, 2026 to Mar 27, 2026
    • Study completion pushed from Jul 27, 2026 to Jan 25, 2027
    • Eligibility criteria expanded, about 17 words
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Mar 27, 2026 to Jul 27, 2026
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07207226
Lead Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Collaborators: Medtronic
Conditions
(from sponsor)
Resistant Hypertension
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov