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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
Sponsor:
Collaborator:
UMC Utrecht
Information provided by (Responsible Party):
University College, London

Brief 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.

Condition or disease
Heart Failure

Detailed 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).


Study Type : Observational
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Heart failure mortality [ Time Frame: 5 years ]
    5 year heart failure cause of death following the first recorded heart failure diagnosis

  2. Cardiovascular mortality [ Time Frame: 5 years ]
    The 5 year cardiovascular mortality following the first recorded heart failure diagnosis.

  3. All-cause mortality [ Time Frame: 5 years ]
    The all cause mortality 5 years following the first recorded heart failure diagnosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

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


Locations
United Kingdom
Farr Institute, University College London
London, United Kingdom, NW1 2DA
Sponsors and Collaborators
University College, London
UMC Utrecht
Investigators
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