Heart Failure Recorded in Primary Care, Hospital Admissions and National Mortality Registry
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|ClinicalTrials.gov Identifier: NCT02551016|
Recruitment Status : Unknown
Verified July 2015 by University College, London.
Recruitment status was: Active, not recruiting
First Posted : September 16, 2015
Last Update Posted : September 16, 2015
|Condition or disease|
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).
|Study Type :||Observational|
|Estimated Enrollment :||100000 participants|
|Official Title:||Capture and Concordance of Heart Failure Recorded in Primary Care, Hospital Admissions and National Mortality Registry: A Cohort Study In 2.1 Million People|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Primary care only
Patients with heart failure recorded in primary care and never hospitalized for heart failure
Primary care and secondary care
Patients with heart failure recorded in primary care with at least one record of a heart failure related hospitalization.
Secondary care only
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 [ Time Frame: 13 years ]Frequency and overlap of heart failure patients recorded in primary care, hospital admissions and as cause of death in the national mortality registry.
- Heart failure mortality [ Time Frame: 5 years ]5 year heart failure cause of death following the first recorded heart failure diagnosis
- Cardiovascular mortality [ Time Frame: 5 years ]The 5 year cardiovascular mortality following the first recorded heart failure diagnosis.
- All-cause mortality [ Time Frame: 5 years ]The all cause mortality 5 years following the first recorded heart failure diagnosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551016
|Farr Institute, University College London|
|London, United Kingdom, NW1 2DA|
|Study Chair:||Stefan Koudstaal, MD PhD||University College, London|
|Study Director:||Folkert W. Asselbergs, MD PhD||University College, London|
|Principal Investigator:||Harry Hemingway, PhD||University College, London|