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

NCT02285322 | Unknown DMC

• 1 other identifier: 10_164R
• Study Type: observational
• Target: 200,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Myocardial Infarction; Stable Angina Pectoris; Heart Failure

Outcome Measures

Primary Outcomes (5)

• 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

• All-cause mortality

  Recorded death of any cause during follow-up

  10 years

• Cardiovascular mortality

  Recorded death due to cardiovascular disease during follow-up

  10 years

• Risk factors for blood pressure control

  Investigation of baseline factors associated with blood pressure control attainment during follow-up

  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)

  10 years

Secondary Outcomes (3)

• First presentation of cardiovascular disease

  10 years

• End-stage renal disease

  10 years

• Management of high blood pressure

  6 months after cohort entry

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Wellcome Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

University College London

London, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Myocardial Infarction; Angina, Stable; Heart Failure

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology and Public Health

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 6, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: April 1, 2015
• Last Updated: November 6, 2014

Record last verified: 2014-11

Locations

GB (1)