HypertensionFrail_BPNCT04662203
Can Frailty Inform the Management of Hypertension in Older People?
An observational study of Hypertension and Frailty, run by University of Leeds.
Trial summary
The purpose of this study was to investigate in large scale routine primary care data whether frailty is a prognostic factor for relevant outcomes in the management of hypertension in older people and whether frailty causes effect modification of the association of blood pressure or blood pressure lowering treatment… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension, Frailty
- How many people
- 145,598 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2007to 1 Jan 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients living in the community registered with a general practitioner in Wales.
Who may be able to join
- Patient registered with a general practitioner contributing to SAIL database for at least 1 year
- Patient with blood pressure measured and recorded at any time after 1st January 2007 and before 1st January 2008, was used as the individual's index start date.
- Patient aged 65 years or older at the time of study entry.
Who cannot join
- Patient did not have a diagnosis of hypertension or did not have blood pressure meeting criteria for hypertension;
- Patient had an established history of cardiovascular disease (previous stroke, heart failure or myocardial infarction) prior to the start date.
About this study
Official title: Is Frailty a Prognostic Factor for Relevant Outcomes in the Management of Hypertension in Older People, and is There Evidence That the Association of Blood Pressure and Outcomes is Different in the Context of Frailty?
The purpose of this study was to investigate in large scale routine primary care data whether frailty is a prognostic factor for relevant outcomes in the management of hypertension in older people and whether frailty causes effect modification of the association of blood pressure or blood pressure lowering treatment and outcomes in older people.
Read the detailed description
A retrospective cohort study used linked electronic health records from the Welsh Secure Anonymised Information Linkage (SAIL) databank. All patients had hypertension in the absence of established cardiovascular disease, and were over the age of 65 years in 2007. Systolic blood pressure and frailty, measured using the electronic frailty index were recorded. Patients were followed up for ten years. Time to event analysis measured first ever major adverse cardiovascular or cerebrovascular event (MACCE), all-cause mortality and injurious falls. Adjustment was made for established cardiovascular risk factors.
- Conditions
- Hypertension, Frailty
- Medical subject headings
- Hypertension, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular events
Myocardial infarction; stroke; new diagnosis of heart failure; cardiovascular death
Measured: 10 years
Secondary outcomes (2)
All-cause mortality
Death from any cause
Measured: 10 years
Injurious falls
Fall leading to fracture of bone and hospital admission
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Oct 2007
- Primary completion1 Jan 2018
- Study completion1 Jan 2021 (estimated)
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
- Retrospective
- Enrolment
- 145,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University, University of Oxford, Dalhousie University
- Responsible party
- Principal investigator, Oliver Todd, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662203
- Sponsor's protocol ID
- RTF107/0117
- Acronym
- Frail_BP
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 10 Dec 2020
- 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 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Frailty a Prognostic Factor for Relevant Outcomes in the Management of Hypertension in Older People, and is There Evidence That the Association of Blood Pressure and Outcomes is Different in the Context of Frailty?
- ClinicalTrials.gov ID
- NCT04662203
- Acronym / sponsor ID
- Frail_BP / RTF107/0117
- Conditions
- Hypertension, Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145,598 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Swansea University, University of Oxford, Dalhousie University
- Study start
- 1 Oct 2007 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 10 Dec 2020 (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.
The purpose of this study was to investigate in large scale routine primary care data whether frailty is a prognostic factor for relevant outcomes in the management of hypertension in older people and whether frailty causes effect modification of the association of blood pressure or blood pressure lowering treatment and outcomes in older people.
Detailed description
A retrospective cohort study used linked electronic health records from the Welsh Secure Anonymised Information Linkage (SAIL) databank. All patients had hypertension in the absence of established cardiovascular disease, and were over the age of 65 years in 2007. Systolic blood pressure and frailty, measured using the electronic frailty index were recorded. Patients were followed up for ten years. Time to event analysis measured first ever major adverse cardiovascular or cerebrovascular event (MACCE), all-cause mortality and injurious falls. Adjustment was made for established cardiovascular risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients living in the community registered with a general practitioner in Wales.
Key inclusion criteria (3 listed)
- Patient registered with a general practitioner contributing to SAIL database for at least 1 year
- Patient with blood pressure measured and recorded at any time after 1st January 2007 and before 1st January 2008, was used as the individual's index start date.
- Patient aged 65 years or older at the time of study entry.
Key exclusion criteria (2 listed)
- Patient did not have a diagnosis of hypertension or did not have blood pressure meeting criteria for hypertension;
- Patient had an established history of cardiovascular disease (previous stroke, heart failure or myocardial infarction) prior to the start date.
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
Major adverse cardiovascular and cerebrovascular events
Time frame: 10 years
Myocardial infarction; stroke; new diagnosis of heart failure; cardiovascular death
2 secondary outcomes
All-cause mortality
Time frame: 10 years
Injurious falls
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Frailty, run by University of Leeds.
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 3 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Major adverse cardiovascular and cerebrovascular events (time frame: 10 years). 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 10 Dec 2020.