NCT02551016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 16, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

August 11, 2015

Last Update Submit

September 14, 2015

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Heart failure mortality

    5 years

  • Cardiovascular mortality

    5 years

  • All-cause mortality

    5 years

Study Arms (3)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • past medical history of heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farr Institute, University College London

London, NW1 2DA, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 23220717BACKGROUND

  • Koudstaal S, Pujades-Rodriguez M, Denaxas S, Gho JMIH, Shah AD, Yu N, Patel RS, Gale CP, Hoes AW, Cleland JG, Asselbergs FW, Hemingway H. Prognostic burden of heart failure recorded in primary care, acute hospital admissions, or both: a population-based linked electronic health record cohort study in 2.1 million people. Eur J Heart Fail. 2017 Sep;19(9):1119-1127. doi: 10.1002/ejhf.709. Epub 2016 Dec 23.

    PMID: 28008698DERIVED

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Stefan Koudstaal, MD PhD

    University College, London

    STUDY CHAIR

  • Folkert W. Asselbergs, MD PhD

    University College, London

    STUDY DIRECTOR

  • Harry Hemingway, PhD

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

September 16, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 16, 2015

Record last verified: 2015-07

Locations

GB(1)