HypertensionVAR-24hFRNCT05818280
Relationship Between 24-hour Blood Pressure Variability and FRagility in the Elderly Patient
An observational study of Hypertension, run by Pr. Nicolas GIRERD at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Hypertension
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2023to 29 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 75 years old, admitted for consultation or day hospitalisation in the Geriatric Service of the CHRU, living at home, with treated or untreated hypertension with clinical indication for an ABPM and Clinical indication for a frailty measurement
Who may be able to join
- Patients over 75 years old, men and women,
- Patients admitted for consultation or day hospitalisation to the Geriatric Service of the CHRU, living at home, with treated or untreated hypertension with :
- Clinical indication for an ABPM
- Clinical indication for a frailty measurement
Who cannot join
- Opposition to the use of data
- Inability to perform ABPM
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Hypertension
- Keywords
- Hypertension, Frail patient
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation of 24 hours Systolic Arterial blood pressure
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
Measured: From inclusion until 24 hours
Secondary outcomes (7)
Coefficient of variation of 24 hours systolic Arterial blood pressure
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
Measured: From inclusion until 24 hours
Standard deviation of 24 hours Diastolic Arterial blood pressure
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
Measured: From inclusion until 24 hours
Standard deviation of 24 hours Pulse arterial blood pressure
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
Measured: From inclusion until 24 hours
Standard deviation of 24 hours Mean arterial blood pressure
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
Measured: From inclusion until 24 hours
Coefficient of variation of 24 hours Diastolic Arterial blood pressure
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
Measured: From inclusion until 24 hours
Coefficient of variation of 24 hours Pulse arterial blood pressure
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
Measured: From inclusion until 24 hours
Coefficient of variation of 24 hours Mean arterial blood pressure
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
Measured: From inclusion until 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start12 Jan 2023
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pr. Nicolas GIRERD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, MD-PhD, Study chair, CHRU de NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818280
- Sponsor's protocol ID
- 2022PI197
- Acronym
- VAR-24hFR
- Status last verified
- Jun 2025
- First submitted
- 4 Apr 2023
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between 24-hour Blood Pressure Variability and FRagility in the Elderly Patient
- ClinicalTrials.gov ID
- NCT05818280
- Acronym / sponsor ID
- VAR-24hFR / 2022PI197
- Conditions
- Hypertension
- Keywords
- Hypertension, Frail patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Pr. Nicolas GIRERDUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 75 years old, admitted for consultation or day hospitalisation in the Geriatric Service of the CHRU, living at home, with treated or untreated hypertension with clinical indication for an ABPM and Clinical indication for a frailty measurement
Key inclusion criteria (4 listed)
- Patients over 75 years old, men and women,
- Patients admitted for consultation or day hospitalisation to the Geriatric Service of the CHRU, living at home, with treated or untreated hypertension with :
- Clinical indication for an ABPM
- Clinical indication for a frailty measurement
Key exclusion criteria (2 listed)
- Opposition to the use of data
- Inability to perform ABPM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Standard deviation of 24 hours Systolic Arterial blood pressure
Time frame: From inclusion until 24 hours
Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)
7 secondary outcomes
Coefficient of variation of 24 hours systolic Arterial blood pressure
Time frame: From inclusion until 24 hours
Standard deviation of 24 hours Diastolic Arterial blood pressure
Time frame: From inclusion until 24 hours
Standard deviation of 24 hours Pulse arterial blood pressure
Time frame: From inclusion until 24 hours
Standard deviation of 24 hours Mean arterial blood pressure
Time frame: From inclusion until 24 hours
Coefficient of variation of 24 hours Diastolic Arterial blood pressure
Time frame: From inclusion until 24 hours
Coefficient of variation of 24 hours Pulse arterial blood pressure
Time frame: From inclusion until 24 hours
Coefficient of variation of 24 hours Mean arterial blood pressure
Time frame: From inclusion until 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas GIRERD, MD-PhD study chair
CHRU de NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Pr. Nicolas GIRERD at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard deviation of 24 hours Systolic Arterial blood pressure (time frame: From inclusion until 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.