Clinical Trials Logo

Clinical Trial Summary

In the 2016's Haute Autorité de Santé (HAS) recommendations (Haute Autorité de Santé. Management of arterial hypertension in adults. Saint-Denis La Plaine: HAS; 2016.) concerning the management of arterial hypertension in adults, the Ambulatory Blood Pressure Measurement (ABPM) is described as a diagnostic tool for hypertension as well as a tool useful for checking blood pressure (BP) control in treated patients. It is also stipulated that ABPM can provide additional information such as the exploration of significant blood pressure variability. The 2014's ESH recommendations (ESH practical guidelines for ambulatory blood pressure monitoring, 2014) concerning ABPM indicate that variability of BP over 24 hours can be considered as a research parameter. Blood Pressure Variability could be a better predictor of organ damage related to hypertension than blood pressure measured in consultation. Furthermore, BP measurement over 24 hours has been demonstrated as a more sensitive risk factor for cardiovascular events such as stroke or ischemic coronary events. It is specified in the 2018 ESH/ESC guidelines on the management of hypertension (Mancia G, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension. 2018) that an additional number of ABPM parameters may have prognostic value such as 24-hour variability even if there is no indication yet of its evaluation in clinical routine. The variability of blood pressure is associated with an increased risk of cardiovascular events, in particular stroke and coronary events in young and hypertensive patients, regardless of their cardiovascular risk factors, mean value of their systolic BP measured in ABPM or during consultation follow-up as shown by Rothwell PM et al. (Prognostic significance of visit-to-visit variability, maximum systolic blood pressure, and episodic hypertension. The Lancet. mars 2010;375(9718):895-905) and Mehlum MH et al. (Blood pressure variability and risk of cardiovascular events and death in patients with hypertension and different baseline risks. Eur Heart J. 21 juin 2018;39(24):2243-51.) Studies also show that BP variability in elderly hypertensive patients is an independent risk factor for cardiovascular events (Eto M et al. Impact of Blood Pressure Variability on Cardiovascular Events in Elderly Patients with Hypertension. Hypertens Res. 2005;28(1):1-7.) and that BP variability would be greater in the elderly patient (Magdás A et al. Ambulatory monitoring derived blood pressure variability and cardiovascular risk factors in elderly hypertensive patients. Biomed Mater Eng. 2014;24(6):2563-9) Finally, a link between frailty and blood pressure variability is demonstrated by Rouch L et al. (Visit-to-Visit Blood Pressure Variability and Incident Frailty in Older Adults. Le Couteur D, éditeur. J Gerontol Ser A. 13 juill 2021;76(8):1369-75.) However, BP variability, measured in this study by blood pressure variation between clinical visits, does not assess overnight variability. Another limitation in the evaluation of frailty is the exclusion of patients with an MMSE < 24. Hussain SM et al. (Variation in Mean Arterial Pressure Increases Falls Risk in Elderly Physically Frail and Prefrail Individuals Treated With Antihypertensive Medication. Hypertension. sept 2022;79(9):2051-61.) also show that BP variability measured by ABPM would increase the risk of serious falls in frail or pre-frail elderly subjects taking antihypertensive treatment. The objective of this study is therefore to evaluate the link between blood pressure variability on 24-hour recordings measured by the standard deviation and the coefficient of variation, according to the frailty status in patients aged over 75 with hypertension, treated or not with antihypertensive molecules.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05818280
Study type Observational
Source Central Hospital, Nancy, France
Contact Lucile ADMANT, MD
Phone (0)3 83 15 49 39
Email l.admant@chru-nancy.fr
Status Not yet recruiting
Phase
Start date April 2023
Completion date April 2024

See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A