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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03733665
Other study ID # DARS-NIC-174209-R8G8N-v0
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 6, 2018
Est. completion date December 31, 2020

Study information

Verified date February 2020
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study is a population-based, patient-level analysis of heart failure in England over a 5-year period using a dataset created by linking HES and NICOR databases. Our analyses will look into the re-occurrence of hospitalisation after the initial diagnosis of heart failure, the influence of population factors on risk of re-hospitalisation, and the resultant cost implications in an NHS environment.


Description:

Data from the National Heart Failure Audit (NICOR) and Hospital Episodes Statistics (NHS Digital) will be linked, by NHS Digital, using fields that are recorded in both databases (for example, NHS number). We will receive de-anonymised data that has been pseudo-anonymised, allowing for patient-level analyses but without identifying individual patients.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80000
Est. completion date December 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients >17 years old

- individual patient data appears on both HES and NICOR databases

- 4-character primary diagnosis codes I50.0-I50.9

Exclusion Criteria:

- patient requests withdrawal from analyses

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patients admitted to hospital
Data is captured in HES for all patient interactions with the NHS (each episode) in England. All patients admitted for heart failure have data captured in the National Heart Failure Audit.

Locations

Country Name City State
United Kingdom King's College London London

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Readmission Any repeat hospitalisation for heart failure 2012-2017
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