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OpenTrials
Completed

NCT Number: NCT03760562

The Risk of Hypertension Associated With Oral Glucocorticoids in Chronic Inflammatory Diseases

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008, it was estimated that 0.8% of the United Kingdom adult population had used long-term (≥ 3 months) glucocorticoids, rising to 3% in women aged over 80 years.

The aim of the project is to investigate the dose-response estimates of risk of high blood pressure associated with oral glucocorticoids.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Hypertension is a chronic condition which affects 1 in 5 of the world adult population. The cause of hypertension is unknown in about 95% of patients, whilst 5% are secondary to underlying adrenal disorders or other identifiable causes.

Glucocorticoids are widely used for the treatment of chronic inflammatory diseases. In 2008, it was estimated that 0.8% of the UK adult population had used long-term (≥ 3 months) glucocorticoids, rising to 3% in women aged over 80 years. Glucocorticoids are effective in controlling underlying chronic inflammatory disease in majority of cases. However, their continuous use can result in a variety of complications, including hypertension.Although it is acknowledged that excess cortisol is a leading cause of hypertension, the role of exogenous glucocorticoids is less known.

The aim of the project is to investigate the dose-response estimates of risk of high blood pressure associated with oral glucocorticoids.

This is a retrospective cohort study of people diagnosed with at least one of six chronic inflammatory diseases (polymyalgia rheumatica, giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, vasculitis and inflammatory bowel disease). This study will be based on the analysis of existing primary care health records routinely collected, linked to hospital and mortality data.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years old or over
  • Registered in a participating general practice 1 year or more during the study period
  • Minimum of 1 year prior to study entry meeting CPRD data quality
  • Diagnosed with at least one of the 6 chronic inflammatory diseases

Exclusion criteria

  • Patients aged under 18 years during the study period
  • Registered in general practices that did not consent to data linkage

Treatment and study plan

Glucocorticoids

Drug

Oral Glucocorticoids.

Primary outcomes

  1. Glucocorticoid-related hypertension

    Time frame: 18 years

    Number of patients with incident hypertension

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Registry information

Official study title

The Risk of Hypertension Associated With Oral Glucocorticoids in Chronic Inflammatory Diseases in England.

Important dates

Study start
1998
Primary completion
2015
Study completion
2015
First posted
Nov 30, 2018
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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