StrokeNCT02285322
Predictors of Blood Pressure Control and Associations With Cardiovascular Diseases in Individuals With High Blood Pressure: a CALIBER Study
An observational study of Stroke and Myocardial Infarction, run by University College, London at 1 site in United Kingdom.
Trial summary
Current guidelines for the clinical management of hypertension in adults recommend to achieve and maintain blood pressure levels of <140/90 mmHg. However, it is uncertain what proportion of individuals identified with high blood pressure in primary care actually reach blood pressure control, what factors are… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Myocardial Infarction, Stable Angina Pectoris
- How many people
- 200,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Apr 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in the CALIBER database who had high blood pressure (the Clinical Practice Research Datalink [CPRD]) and consenting to data linkage. High blood pressure was defined as the record of ≥3 systolic or diastolic high blood pressure readings within a one year period, or ≥2 systolic or diastolic high blood pressure readings within a 6 month period in CPRD. High blood pressure measurements were defined as in the eighth Joint National Committee (2014 JNC8) guidelines for patient management, that is ≥140/90mmHg for individuals aged less than 60 years old, and ≥150/90mmHg for those of ≥60 years.
Who may be able to join
- Patients aged 18 and over
- Registered with a participating general practice during the study period
- Minimum one year of records prior to study entry meeting CPRD data quality
- Diagnosed with high blood pressure in the period January 1997 - March 2010
Who cannot join
- Patients without record of gender
- Patients with prior atherosclerotic disease, as recorded in primary care or hospitalisation data
- Patients with less than 6 months of follow-up since diagnosis of high blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
Current guidelines for the clinical management of hypertension in adults recommend to achieve and maintain blood pressure levels of <140/90 mmHg. However, it is uncertain what proportion of individuals identified with high blood pressure in primary care actually reach blood pressure control, what factors are associated with attainment of control and to what extent blood pressure control attainment is associated with cardiovascular diseases in a contemporary population of individuals diagnosed with high blood pressure.
The aim of this study is to investigate the extent to which patients achieve blood pressure control and associated risk factors, time to attainment of blood pressure control and whether this time is associated with an increased risk of CVD onset, all-cause and cardiovascular disease and end-stage renal disease.
Read the detailed description
An increment of 20 mmHg of systolic blood pressure (or approximately equivalent 10 mmHg diastolic blood pressure) is associated with more than a two-fold increase in risk of fatal stroke, and with a two-fold increase in fatal ischemic heart diseases in individuals aged 40-69 years. The management and control of high blood pressure is therefore one of the most important components of primary and secondary strategies for prevention of cardiovascular mortality and morbidity. Current guidelines for the clinical management of hypertension in adults recommend to achieve and maintain blood pressure levels of <140/90 mmHg. However, it is uncertain what proportion of individuals identified with high blood pressure in primary care actually reach blood pressure control, what factors are associated with attainment of control and to what extent blood pressure control attainment is associated with cardiovascular diseases in a contemporary population of individuals diagnosed with high blood pressure. This is important for clinicians and policy decision makers in order to design and implement effective strategies for patient management.
The aim of this study is to investigate the extent to which patients achieve blood pressure control and associated risk factors, time to attainment of blood pressure control and whether this time is associated with an increased risk of CVD onset, all-cause and cardiovascular disease and end-stage renal disease.
The study will use data from the CALIBER data set of clinically collected electronic health record data from England.
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the National Institute for Health Research (NIHR) and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (Clinical Practice Research Datalink - CPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER data set).
- Conditions
- Stroke, Myocardial Infarction, Stable Angina Pectoris, Heart Failure
- Medical subject headings
- Stroke, Myocardial Infarction, Angina, Stable, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BP control reached | Patients diagnosed with high blood pressure who lowered their blood pressure measurements during follow-up to <140/90mmHg if aged less than 60 years old, and <150/90mmHg for those of ≥60 years | |
| BP control not reached | Patients diagnosed with high blood pressure who did not lower their blood pressure measurement during follow-up (measurements were ≥140/90mmHg for individuals aged less than 60 years old, and ≥150/90mmHg for those of ≥60 years) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First presentation of cardiovascular disease
First recorded diagnosis of cardiovascular disease during follow-up: myocardial infarction, stroke (haemorrhagic or ischemic), heart failure, coronary revascularisation
Measured: 10 years
All-cause mortality
Recorded death of any cause during follow-up
Measured: 10 years
Cardiovascular mortality
Recorded death due to cardiovascular disease during follow-up
Measured: 10 years
Risk factors for blood pressure control
Investigation of baseline factors associated with blood pressure control attainment during follow-up
Measured: 10 years
Coronary revascularisation
First recorded percutaneous coronary intervention or coronary artery bypass graft (excluding interventions performed within 30 days before or after a diagnosis of myocardial infarction)
Measured: 10 years
Secondary outcomes (3)
First presentation of cardiovascular disease
First recorded diagnosis of cardiovascular disease during follow-up: stable angina pectoris and atrial fibrillation
Measured: 10 years
End-stage renal disease
Recorded kidney disease resulting in dialysis or kidney transplantation during follow-up
Measured: 10 years
Management of high blood pressure
Description of patient management in the 6 months after diagnosis of high blood pressure in terms of: blood pressure lowering medication start, timing and class; smoking cessation; dietary advice; physical activity; weight and total cholesterol decrease; and HDL-cholesterol increase
Measured: 6 months after cohort entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Harry Hemingway, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02285322
- Sponsor's protocol ID
- 10_164R
- Status last verified
- Nov 2014
- First submitted
- 4 Nov 2014
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Blood Pressure Control and Associations With Cardiovascular Diseases in Individuals With High Blood Pressure: a CALIBER Study
- ClinicalTrials.gov ID
- NCT02285322
- Acronym / sponsor ID
- 10_164R
- Conditions
- Stroke, Myocardial Infarction, Stable Angina Pectoris, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Apr 2015 (estimated)
- First posted
- 6 Nov 2014 (estimated)
- 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.
Current guidelines for the clinical management of hypertension in adults recommend to achieve and maintain blood pressure levels of <140/90 mmHg. However, it is uncertain what proportion of individuals identified with high blood pressure in primary care actually reach blood pressure control, what factors are associated with attainment of control and to what extent blood pressure control attainment is associated with cardiovascular diseases in a contemporary population of individuals diagnosed with high blood pressure.
The aim of this study is to investigate the extent to which patients achieve blood pressure control and associated risk factors, time to attainment of blood pressure control and whether this time is associated with an increased risk of CVD onset, all-cause and cardiovascular disease and end-stage renal disease.
Detailed description
An increment of 20 mmHg of systolic blood pressure (or approximately equivalent 10 mmHg diastolic blood pressure) is associated with more than a two-fold increase in risk of fatal stroke, and with a two-fold increase in fatal ischemic heart diseases in individuals aged 40-69 years. The management and control of high blood pressure is therefore one of the most important components of primary and secondary strategies for prevention of cardiovascular mortality and morbidity. Current guidelines for the clinical management of hypertension in adults recommend to achieve and maintain blood pressure levels of <140/90 mmHg. However, it is uncertain what proportion of individuals identified with high blood pressure in primary care actually reach blood pressure control, what factors are associated with attainment of control and to what extent blood pressure control attainment is associated with cardiovascular diseases in a contemporary population of individuals diagnosed with high blood pressure. This is important for clinicians and policy decision makers in order to design and implement effective strategies for patient management.
The aim of this study is to investigate the extent to which patients achieve blood pressure control and associated risk factors, time to attainment of blood pressure control and whether this time is associated with an increased risk of CVD onset, all-cause and cardiovascular disease and end-stage renal disease.
The study will use data from the CALIBER data set of clinically collected electronic health record data from England.
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the National Institute for Health Research (NIHR) and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (Clinical Practice Research Datalink - CPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER data set).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP control reached | – | –Patients diagnosed with high blood pressure who lowered their blood pressure measurements during follow-up to <140/90mmHg if aged less than 60 years old, and <150/90mmHg for those of ≥60 years |
| BP control not reached | – | –Patients diagnosed with high blood pressure who did not lower their blood pressure measurement during follow-up (measurements were ≥140/90mmHg for individuals aged less than 60 years old, and ≥150/90mmHg for those of ≥60 years) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the CALIBER database who had high blood pressure (the Clinical Practice Research Datalink [CPRD]) and consenting to data linkage. High blood pressure was defined as the record of ≥3 systolic or diastolic high blood pressure readings within a one year period, or ≥2 systolic or diastolic high blood pressure readings within a 6 month period in CPRD. High blood pressure measurements were defined as in the eighth Joint National Committee (2014 JNC8) guidelines for patient management, that is ≥140/90mmHg for individuals aged less than 60 years old, and ≥150/90mmHg for those of ≥60 years.
Key inclusion criteria (4 listed)
- Patients aged 18 and over
- Registered with a participating general practice during the study period
- Minimum one year of records prior to study entry meeting CPRD data quality
- Diagnosed with high blood pressure in the period January 1997 - March 2010
Key exclusion criteria (3 listed)
- Patients without record of gender
- Patients with prior atherosclerotic disease, as recorded in primary care or hospitalisation data
- Patients with less than 6 months of follow-up since diagnosis of high blood pressure
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
First presentation of cardiovascular disease
Time frame: 10 years
First recorded diagnosis of cardiovascular disease during follow-up: myocardial infarction, stroke (haemorrhagic or ischemic), heart failure, coronary revascularisation
All-cause mortality
Time frame: 10 years
Recorded death of any cause during follow-up
Cardiovascular mortality
Time frame: 10 years
Recorded death due to cardiovascular disease during follow-up
Risk factors for blood pressure control
Time frame: 10 years
Investigation of baseline factors associated with blood pressure control attainment during follow-up
Coronary revascularisation
Time frame: 10 years
First recorded percutaneous coronary intervention or coronary artery bypass graft (excluding interventions performed within 30 days before or after a diagnosis of myocardial infarction)
3 secondary outcomes
First presentation of cardiovascular disease
Time frame: 10 years
End-stage renal disease
Time frame: 10 years
Management of high blood pressure
Time frame: 6 months after cohort entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke and Myocardial Infarction, run by University College, London at 1 site in United Kingdom.
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 3 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 6 Nov 2014. 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 United Kingdom. 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?
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?
First presentation of cardiovascular disease (time frame: 10 years). The study lists 5 primary outcomes in all. 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 6 Nov 2014.