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Predictors of Blood Pressure Control and Associations With Cardiovascular Diseases in Individuals With High Blood Pressure: a CALIBER Study

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ClinicalTrials.gov Identifier: NCT02285322
Recruitment Status : Unknown
Verified November 2014 by Harry Hemingway, University College, London.
Recruitment status was:  Active, not recruiting
First Posted : November 6, 2014
Last Update Posted : November 6, 2014
Sponsor:
Collaborators:
Wellcome Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Harry Hemingway, University College, London

Brief 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 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.


Condition or disease
Stroke Myocardial Infarction Stable Angina Pectoris Heart Failure

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 Type : Observational
Estimated Enrollment : 200000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Blood Pressure Control and Associations With Cardiovascular Diseases in Individuals With High Blood Pressure: a CALIBER Study
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Estimated Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Group/Cohort
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)



Primary Outcome Measures :
  1. 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

  2. All-cause mortality [ Time Frame: 10 years ]
    Recorded death of any cause during follow-up

  3. Cardiovascular mortality [ Time Frame: 10 years ]
    Recorded death due to cardiovascular disease during follow-up

  4. Risk factors for blood pressure control [ Time Frame: 10 years ]
    Investigation of baseline factors associated with blood pressure control attainment during follow-up

  5. 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)


Secondary Outcome Measures :
  1. First presentation of cardiovascular disease [ Time Frame: 10 years ]
    First recorded diagnosis of cardiovascular disease during follow-up: stable angina pectoris and atrial fibrillation

  2. End-stage renal disease [ Time Frame: 10 years ]
    Recorded kidney disease resulting in dialysis or kidney transplantation during follow-up

  3. Management of high blood pressure [ Time Frame: 6 months after cohort entry ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285322


Locations
United Kingdom
University College London
London, United Kingdom
Sponsors and Collaborators
University College, London
Wellcome Trust
National Institute for Health Research, United Kingdom

Responsible Party: Harry Hemingway, Professor of Epidemiology and Public Health, University College, London
ClinicalTrials.gov Identifier: NCT02285322     History of Changes
Other Study ID Numbers: 10_164R
First Posted: November 6, 2014    Key Record Dates
Last Update Posted: November 6, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Heart Failure
Infarction
Cardiovascular Diseases
Myocardial Infarction
Angina Pectoris
Angina, Stable
Hypertension
Heart Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms