Overview

This trial is active, not recruiting.

Conditions stroke, myocardial infarction, stable angina pectoris, heart failure
Sponsor University College, London
Collaborator Wellcome Trust
Start date January 2014
End date June 2014
Trial size 200000 participants
Trial identifier NCT02285322, 10_164R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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
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 Outcomes

Measure
First presentation of cardiovascular disease
time frame: 10 years
All-cause mortality
time frame: 10 years
Cardiovascular mortality
time frame: 10 years
Risk factors for blood pressure control
time frame: 10 years
Coronary revascularisation
time frame: 10 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Predictors of Blood Pressure Control and Associations With Cardiovascular Diseases in Individuals With High Blood Pressure: a CALIBER Study
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by University College, London.