Heart FailureNCT03733665
HES and NICOR Data Linkage for Cardiac Failure Population Analysis
An observational study of Heart Failure and Registries, run by King's College London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Registries, Patient Readmission
- What is being tested?
- Patients admitted to hospital
- How many people
- 80,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Nov 2018to 31 Dec 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients >17 years old
- individual patient data appears on both HES and NICOR databases
- 4-character primary diagnosis codes I50.0-I50.9
Who cannot join
- patient requests withdrawal from analyses
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Registries, Patient Readmission
- Being tested
- Patients admitted to hospital
- Keywords
- Hospital Episode Statistics, HES, National Institute for Cardiovascular Outcomes Research, NICOR, National Heart Failure Audit
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients admitted to hospitalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Patients admitted to hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
Any repeat hospitalisation for heart failure
Measured: 2012-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start6 Nov 2018
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anastasia Chalkidou, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733665
- Sponsor's protocol ID
- DARS-NIC-174209-R8G8N-v0
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HES and NICOR Data Linkage for Cardiac Failure Population Analysis
- ClinicalTrials.gov ID
- NCT03733665
- Acronym / sponsor ID
- DARS-NIC-174209-R8G8N-v0
- Conditions
- Heart Failure, Registries, Patient Readmission
- Keywords
- Hospital Episode Statistics, HES, National Institute for Cardiovascular Outcomes Research, NICOR, National Heart Failure Audit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80,000 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure patients | – | Other: Patients admitted to hospitalAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients >17 years old
- individual patient data appears on both HES and NICOR databases
- 4-character primary diagnosis codes I50.0-I50.9
Key exclusion criteria (1 listed)
- patient requests withdrawal from analyses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients admitted to hospitalData 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. | Other | Heart failure patients |
Primary outcome
Readmission
Time frame: 2012-2017
Any repeat hospitalisation for heart failure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Privacy notice and patient notification informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anastasia Chalkidou principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Registries, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission (time frame: 2012-2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.