Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

HES and NICOR Data Linkage for Cardiac Failure Population Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03733665
Recruitment Status : Active, not recruiting
First Posted : November 7, 2018
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
King's College London

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.

Condition or disease Intervention/treatment
Heart Failure Registries Patient Readmission Other: Patients admitted to hospital

Detailed 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 80000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: HES and NICOR Data Linkage for Cardiac Failure Population Analysis
Actual Study Start Date : November 6, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Readmission [ Time Frame: 2012-2017 ]
    Any repeat hospitalisation for heart failure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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

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): NCT03733665


Locations
Layout table for location information
United Kingdom
King's College London
London, United Kingdom
Sponsors and Collaborators
King's College London
Investigators
Layout table for investigator information
Principal Investigator: Anastasia Chalkidou King's College London
Additional Information:
Layout table for additonal information
Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03733665    
Other Study ID Numbers: DARS-NIC-174209-R8G8N-v0
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Hospital Episode Statistics
HES
National Institute for Cardiovascular Outcomes Research
NICOR
National Heart Failure Audit
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases