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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02285322
• Other study ID #: 10_164R
• Status: Active, not recruiting
• Phase: N/A
• First received: November 4, 2014
• Last updated: November 4, 2014
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: November 2014
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines & Healthcare products Regulatory Agency
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200000
• Est. completion date: April 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Cardiovascular Diseases
• Heart Failure
• Hypertension
• Myocardial Infarction
• Stable Angina Pectoris
• Stroke

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	National Institute for Health Research, United Kingdom, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First presentation of cardiovascular disease	First recorded diagnosis of cardiovascular disease during follow-up: myocardial infarction, stroke (haemorrhagic or ischemic), heart failure, coronary revascularisation	10 years	No
Primary	All-cause mortality	Recorded death of any cause during follow-up	10 years	No
Primary	Cardiovascular mortality	Recorded death due to cardiovascular disease during follow-up	10 years	No
Primary	Risk factors for blood pressure control	Investigation of baseline factors associated with blood pressure control attainment during follow-up	10 years	No
Primary	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)	10 years	No
Secondary	First presentation of cardiovascular disease	First recorded diagnosis of cardiovascular disease during follow-up: stable angina pectoris and atrial fibrillation	10 years	No
Secondary	End-stage renal disease	Recorded kidney disease resulting in dialysis or kidney transplantation during follow-up	10 years	No
Secondary	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	6 months after cohort entry	No