FrailtyHYPER-FRAILNCT05776394
Study on Hypertension and Frailty in the Older People
An observational study of Frailty and High Blood Pressure, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
To estimate the linear association between daytime systolic blood pressure variability evaluated as standard deviation (SD) and frailty evaluated as Frailty index according to the Rockwood's accumulation of deficits model Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Frailty, High Blood Pressure
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2022to 31 Oct 2023
- 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
- Older adult
Study population: Elderly patients
Who may be able to join
- Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines
- Consent of the patient (or legal representative) to participate in the study
Who cannot join
- Refusal of the patient or his/her legal representative
- Life expectancy of less than 6 months
Trial locations and contacts
1 site in 1 country.
Martino IT Pengo, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Luca
Milan, 28145
Croce Alessandro, MD, +3961911 ext. 2830, a.croce@auxologico.it
About this study
Official title: Study on Hypertension and Frailty in the Older People: the HYPER-FRAIL Study
To estimate the linear association between daytime systolic blood pressure variability evaluated as standard deviation (SD) and frailty evaluated as Frailty index according to the Rockwood's accumulation of deficits model
- Conditions
- Frailty, High Blood Pressure
- Medical subject headings
- Frailty, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Daytime systolic blood pressure variability
Standard deviation of daytime systolic blood pressure
Measured: At baseline
Secondary outcomes (2)
Nighttime systolic blood pressure variability
Standard deviation of nighttime systolic blood pressure
Measured: At baseline
24h systolic blood pressure variability
Standard deviation of 24h systolic blood pressure
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start30 May 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776394
- Sponsor's protocol ID
- 09C214
- Acronym
- HYPER-FRAIL
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Hypertension and Frailty in the Older People: the HYPER-FRAIL Study
- ClinicalTrials.gov ID
- NCT05776394
- Acronym / sponsor ID
- HYPER-FRAIL / 09C214
- Conditions
- Frailty, High Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 20 Mar 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.
To estimate the linear association between daytime systolic blood pressure variability evaluated as standard deviation (SD) and frailty evaluated as Frailty index according to the Rockwood's accumulation of deficits model
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly patients
Key inclusion criteria (2 listed)
- Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines
- Consent of the patient (or legal representative) to participate in the study
Key exclusion criteria (2 listed)
- Refusal of the patient or his/her legal representative
- Life expectancy of less than 6 months
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
Daytime systolic blood pressure variability
Time frame: At baseline
Standard deviation of daytime systolic blood pressure
2 secondary outcomes
Nighttime systolic blood pressure variability
Time frame: At baseline
24h systolic blood pressure variability
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Martino IT Pengo, PhD contact
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 Frailty and High Blood Pressure, run by Istituto Auxologico Italiano at 1 site in Italy.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro IT Croce, MD (0261911 ext. 2730, a.croce@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daytime systolic blood pressure variability (time frame: At baseline). 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 20 Mar 2023.