Heart Failure Recorded in Primary Care, Hospital Admissions and National Mortality Registry

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02551016
• Other study ID #: 14_149SK
• Status: Active, not recruiting
• Phase: N/A
• First received: August 11, 2015
• Last updated: September 14, 2015
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100000
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United Kingdom	Farr Institute, University College London	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	UMC Utrecht

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Denaxas SC, George J, Herrett E, Shah AD, Kalra D, Hingorani AD, Kivimaki M, Timmis AD, Smeeth L, Hemingway H. Data resource profile: cardiovascular disease research using linked bespoke studies and electronic health records (CALIBER). Int J Epidemiol. 2012 Dec;41(6):1625-38. doi: 10.1093/ije/dys188. Epub 2012 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	13 years	No
Secondary	Heart failure mortality	5 year heart failure cause of death following the first recorded heart failure diagnosis	5 years	No
Secondary	Cardiovascular mortality	The 5 year cardiovascular mortality following the first recorded heart failure diagnosis.	5 years	No
Secondary	All-cause mortality	The all cause mortality 5 years following the first recorded heart failure diagnosis	5 years	No

External Links

•   Portal to CALIBER research programme