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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • CHRU de NANCY

    Vandœuvre-lès-Nancy, 54500

Other trials in France

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.

  1. 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)
  1. 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

  2. Standard deviation of 24 hours Diastolic Arterial blood pressure

    Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)

    Measured: From inclusion until 24 hours

  3. Standard deviation of 24 hours Pulse arterial blood pressure

    Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)

    Measured: From inclusion until 24 hours

  4. Standard deviation of 24 hours Mean arterial blood pressure

    Assessed on 24-hour Arterial Blood Pressure Measurement (ABPM)

    Measured: From inclusion until 24 hours

  5. 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

  6. 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

  7. 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.

  1. First posted18 Apr 2023
  2. Study start12 Jan 2023
  3. Primary completion29 Aug 2024
  4. Study completion29 Aug 2024

Resources

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)
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

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.

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