Heart FailureNCT02353481
1 Year Post Discharge Prognostic Model From the National Heart Failure Audit (NHFA)
An observational study of Heart Failure, run by University College, London at 1 site in United Kingdom.
Trial summary
The aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in England and Wales. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart Failure Management
- How many people
- 63,320 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2012to Mar 2015
- 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: Unscheduled heart failure admissions in England and Wales are recorded in the National Heart Failure Audit. Therefore, patients with data in the audit will be eligible for inclusion if they meet the inclusion criteria listed below.
Who may be able to join
- aged 18 and above
- survived to discharge
- have mortality status at 1 year post-discharge
Who cannot join
- Non-index heart failure admissions during the study period will be excluded from the study sample.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in England and Wales.
Read the detailed description
There is a need for a prognostic model for 1 year survival of patients discharged alive after an unscheduled hospital admission for heart failure. This study aims to develop and validate a prognostic model that will enable management planning and facilitate the identification of therapeutic needs or targets. Also, it will assist care providers to predict or quantify patients' survival based on their baseline characteristics.
The National Heart Failure Audit (NHFA) held by National Institute for Cardiovascular Outcomes Research (NICOR) is one of the largest available national heart failure registry. It includes data from unscheduled heart failure admissions in England and Wales. In the audit, heart failure diagnosis is defined as a diagnosis that has been confirmed by imaging or brain natriuretic peptide (BNP) measurement. This study will use NHFA data to develop and validate the proposed model.
- Conditions
- Heart Failure
- Being tested
- Heart Failure Management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure ManagementOther
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure | All patients in the audit that meets the eligibility criteria Receives: Other: Heart Failure Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2015 (estimated)
- Study startApr 2012
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University 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
- Retrospective
- Enrolment
- 63,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Cardiovascular Outcomes Research, British Society for Heart Failure
- Responsible party
- Principal investigator, Aminat J Shote, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353481
- Sponsor's protocol ID
- NICOR-Heart Failure
- Status last verified
- Feb 2015
- First submitted
- 28 Jan 2015
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pocock SJ, Wang D, Pfeffer MA, Yusuf S, McMurray JJ, Swedberg KB, Ostergren J, Michelson EL, Pieper KS, Granger CB. Predictors of mortality and morbidity in patients with chronic heart failure. Eur Heart J. 2006 Jan;27(1):65-75. doi: 10.1093/eurheartj/ehi555. Epub 2005 Oct 11.
PubMed 16219658Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
PubMed 15846257Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, Anand I, Maggioni A, Burton P, Sullivan MD, Pitt B, Poole-Wilson PA, Mann DL, Packer M. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation. 2006 Mar 21;113(11):1424-33. doi: 10.1161/CIRCULATIONAHA.105.584102. Epub 2006 Mar 13.
PubMed 16534009Pocock SJ, Ariti CA, McMurray JJ, Maggioni A, Kober L, Squire IB, Swedberg K, Dobson J, Poppe KK, Whalley GA, Doughty RN; Meta-Analysis Global Group in Chronic Heart Failure. Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies. Eur Heart J. 2013 May;34(19):1404-13. doi: 10.1093/eurheartj/ehs337. Epub 2012 Oct 24.
PubMed 23095984
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1 Year Post Discharge Prognostic Model From the National Heart Failure Audit (NHFA)
- ClinicalTrials.gov ID
- NCT02353481
- Acronym / sponsor ID
- NICOR-Heart Failure
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63,320 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- National Institute for Cardiovascular Outcomes Research, British Society for Heart Failure
- Study start
- Apr 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 2 Feb 2015 (estimated)
- 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.
The aim of the study is to develop and assess a prognostic model for patient's survival up to 1 year after unscheduled acute heart failure hospital admission in England and Wales.
Detailed description
There is a need for a prognostic model for 1 year survival of patients discharged alive after an unscheduled hospital admission for heart failure. This study aims to develop and validate a prognostic model that will enable management planning and facilitate the identification of therapeutic needs or targets. Also, it will assist care providers to predict or quantify patients' survival based on their baseline characteristics.
The National Heart Failure Audit (NHFA) held by National Institute for Cardiovascular Outcomes Research (NICOR) is one of the largest available national heart failure registry. It includes data from unscheduled heart failure admissions in England and Wales. In the audit, heart failure diagnosis is defined as a diagnosis that has been confirmed by imaging or brain natriuretic peptide (BNP) measurement. This study will use NHFA data to develop and validate the proposed model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure | – | Other: Heart Failure ManagementAll patients in the audit that meets the eligibility criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Unscheduled heart failure admissions in England and Wales are recorded in the National Heart Failure Audit. Therefore, patients with data in the audit will be eligible for inclusion if they meet the inclusion criteria listed below.
Key inclusion criteria (3 listed)
- aged 18 and above
- survived to discharge
- have mortality status at 1 year post-discharge
Key exclusion criteria (1 listed)
- Non-index heart failure admissions during the study period will be excluded from the study sample.
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 |
|---|---|---|
| Heart Failure Management | Other | Heart Failure |
Primary outcome
All-cause mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2015.
- Background: PubMed 16219658Pocock SJ, Wang D, Pfeffer MA, Yusuf S, McMurray JJ, Swedberg KB, Ostergren J, Michelson EL, Pieper KS, Granger CB. Predictors of mortality and morbidity in patients with chronic heart failure. Eur Heart J. 2006 Jan;27(1):65-75. doi: 10.1093/eurheartj/ehi555. Epub 2005 Oct 11.
- Background: PubMed 15846257Adams KF Jr, Fonarow GC, Emerman CL, LeJemtel TH, Costanzo MR, Abraham WT, Berkowitz RL, Galvao M, Horton DP; ADHERE Scientific Advisory Committee and Investigators. Characteristics and outcomes of patients hospitalized for heart failure in the United States: rationale, design, and preliminary observations from the first 100,000 cases in the Acute Decompensated Heart Failure National Registry (ADHERE). Am Heart J. 2005 Feb;149(2):209-16. doi: 10.1016/j.ahj.2004.08.005.
- Background: PubMed 16534009Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, Anand I, Maggioni A, Burton P, Sullivan MD, Pitt B, Poole-Wilson PA, Mann DL, Packer M. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation. 2006 Mar 21;113(11):1424-33. doi: 10.1161/CIRCULATIONAHA.105.584102. Epub 2006 Mar 13.
- Background: PubMed 23095984Pocock SJ, Ariti CA, McMurray JJ, Maggioni A, Kober L, Squire IB, Swedberg K, Dobson J, Poppe KK, Whalley GA, Doughty RN; Meta-Analysis Global Group in Chronic Heart Failure. Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies. Eur Heart J. 2013 May;34(19):1404-13. doi: 10.1093/eurheartj/ehs337. Epub 2012 Oct 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University 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 3 Feb 2015. 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?
All-cause mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353481, which also lists 4 linked publications.
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 3 Feb 2015.