NCT03733665

Brief 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.

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
80,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

November 6, 2018

Last Update Submit

February 19, 2020

Conditions

Keywords

Hospital Episode StatisticsHESNational Institute for Cardiovascular Outcomes ResearchNICORNational Heart Failure Audit

Outcome Measures

Primary Outcomes (1)

  • Readmission

    Any repeat hospitalisation for heart failure

    2012-2017

Study Arms (1)

Heart failure patients

All patients in NICOR's National Heart Failure Audit will be matched to those in NHS Digital's HES database who have a 4-character primary diagnosis of I50.0-I50.9.

Other: Patients admitted to hospital

Interventions

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.

Heart failure patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Acute decompensated heart failure (ADHF) is a sudden worsening of the signs and symptoms of heart failure, which typically includes difficulty breathing (dyspnoea) and leg oedema. ADHF is a common and potentially serious cause of acute respiratory distress. Treatment of ADHF consists of reducing the excess fluid retention with diuretics along with improving heart function with pharmacological treatment. Although pharmacological treatments exist for heart failure patients with reduced ejection fraction (ACE inhibitors, beta-blockers), a substantial fraction of patients exhibit preserved ejection fraction where treatment consists solely of management of comorbidities and symptoms.

You may qualify if:

  • patients \>17 years old
  • individual patient data appears on both HES and NICOR databases
  • character primary diagnosis codes I50.0-I50.9

You may not qualify if:

  • patient requests withdrawal from analyses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Anastasia Chalkidou

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 7, 2018

Study Start

November 6, 2018

Primary Completion

October 31, 2020

Study Completion

December 31, 2020

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations