An observational study in Heart Failure, sponsored by University College, London. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-16.
Sponsored by University College, London · Observational
The main objectives of this study are i) to assess how heart failure was captured accross different linked electronic health record sources within the CALIBER program and the overlap between primary care, hospital admissions and/or the national mortality register, and ii) to assess risk factors, heart failure treatment and survival in patients, stratified by EHR source.
Heart failure (HF) is one of the leading causes of hospital admissions and mortality in modern healthcare systems. It can be viewed as a collective clinical syndrome of many signs and symptoms and is frequently the common endpoint of various heart diseases. Often, it is not diagnosed until it has reached a level whereby quality of life is significantly, and often irreversibly, impaired. Even though vast quantities of National Health Service (NHS) data concerning patients with heart failure are recorded, there are limited 'real world' longitudinal insights about the prognosis and consequences of HF. Although linked electronic health records cohorts such as the CALIBER program become increasingly available, for heart failure the overlap, risk factors and subsequent mortality have not been compared. Previous studies on heart failure using EHR sources have used ICD-9 or 10 codes for the identification of heart failure cases and the prevalence estimates of risk factors and comorbidity. Furthermore, the assessment of supporting information for heart failure present in electronic healthcare registries remains largely unknown. Currently, heart failure is typically inferred based on previous reports or the prescription of heart failure related medication. To strengthen heart failure case ascertainment in large electronic healthcare registries, linkages with primary care data such as what is done in CALIBER could allow more detailed insight in medical history, clinical diagnoses, anthropometric measures, health behaviour, laboratory tests, medical procedures and prescriptions.
In this study, the investigators assessed the distribution of recording, supportive medical information for heart failure diagnosis, risk factors and subsequent mortality of heart failure patients captured in linked EHR data from primary care, hospital admissions and/or death registry.
This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 100,000 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
From 1 January 1997, all patients aged ≥18 years old, registered in CPRD practices in England consenting to data linkage, with at least one year of up-to-standard pre-study follow-up are potentially eligible.
Exclusion Criteria:
Patients with heart failure recorded in primary care and never hospitalized for heart failure
Patients with heart failure recorded in primary care with at least one record of a heart failure related hospitalization.
Patients with heart failure recorded in at least one heart failure related hospitalization without a concurrent primary care record.
Venn diagram of heart failure recording by data source
Frequency and overlap of heart failure patients recorded in primary care, hospital admissions and as cause of death in the national mortality registry.
Time frame: 13 years
Heart failure mortality
5 year heart failure cause of death following the first recorded heart failure diagnosis
Time frame: 5 years
Cardiovascular mortality
The 5 year cardiovascular mortality following the first recorded heart failure diagnosis.
Time frame: 5 years
All-cause mortality
The all cause mortality 5 years following the first recorded heart failure diagnosis
Time frame: 5 years
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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University College, London