This trial is active, not recruiting.

Condition heart failure
Sponsor University College, London
Collaborator UMC Utrecht
Start date July 2015
End date December 2015
Trial size 100000 participants
Trial identifier NCT02551016, 14_149SK


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.

Primary Outcomes

Venn diagram of heart failure recording by data source
time frame: 13 years

Secondary Outcomes

Heart failure mortality
time frame: 5 years
Cardiovascular mortality
time frame: 5 years
All-cause mortality
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with a coded diagnosis for heart failure in primary care or hospital admission - Patients with a coded diagnosis for heart failure as a cause of death in the national mortality register - Patients in CPRD practices which are deemed "up to standard" for more than 1 year by CPRD criteria. - Patients with at least one year of follow-up in the CPRD practice CPRD. Exclusion Criteria: - past medical history of heart failure

Additional Information

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
Principal investigator Harry Hemingway, PhD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by University College, London.