Heart FailureNCT04398563
Heart Failure in Norway: Clinical Characteristics, Mortality and Health Care Resource Use
An observational study of Heart Failure and Heart Failure With Preserved Ejection Fraction, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The prevalence of Heart failure above 70 years of age is 10% and 5 year mortality rate above 60%, higher than for cancer. The readmission rate first after hospitalisation is 44% despite the availability of life prolonging and life quality enhancing treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction
- How many people
- 14,998 participants
- Where
- 1 siteNorway
- Study dates
- 20 Jan 2020to Dec 2023
- 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: All patients admitted to a University Hospital serving a population of approx. 600 000 inhabitants with heart failure diagnosis in the period 2007 to 2019. In total 14998 patients. Mortality according to The Norwegian Death Registry for all up until 31st of December 2019. In addition all patients with a diagnosis of COPD in the same period as well as all subjects with NT-proBNP above age specific normal range
Who may be able to join
None listed.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Failure in Norway: Combining Artificial Intelligence and a Database of 15000 Patients to Understand Clinical Characteristics, Mortality and Health Care Resource Use
The prevalence of Heart failure above 70 years of age is 10% and 5 year mortality rate above 60%, higher than for cancer. The readmission rate first after hospitalisation is 44% despite the availability of life prolonging and life quality enhancing treatment. There is a lack of resources for adequate diagnostic workup necessary for implementing evidence-based treatment. This projects aims at assessing the impact of guidelines based diagnostic workup and guidelines based treatment of heart failure on mortality and readmission rates. As the symptoms defining the degree of heart failure and the discharge medication only is available in the electronic patient files, artificial intelligence is used to retrieve this information to assess if treatment is according to guidelines.
The project is using first a rule based text processing approach using IBM Watson, then advancing to a machine learning approach using readmission and mortality as endpoints.
The project has access to digitally stored echocardiographic measurements as well as digital ECG's and lab data on 15 000 patients admitted with a diagnosis of Heart failure. If the retrieval of symptoms and function by artificial intelligence is successful, the next step is to assess if those benefitting the most from echocardiography can be identified using information from the ECG's, lab data or symptoms and functional capacity as described in the Electronic Health Records.
- Conditions
- Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
1 year mortality rate after first diagnosis of heart failure
Measured: Change over 12 years
Readmission
30 days and 1 year readmission rate
Measured: Change over 12 years
Secondary outcomes (2)
Diagnostic work up according to guidelines
Proportion with echocardiography and other necessary investigations
Measured: Within 6 months before or after first diagnosis
Treatment according to guidelines
Proportion treated according to guidelines
Measured: within first year after first diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start20 Jan 2020
- Primary completionJun 2021 (estimated)
- Study completionDec 2023 (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.
- 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
- 14,998 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Torbjorn Omland, University Hospital, Akershus
- Investigators
- Henrik Schirmer, MD, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398563
- Sponsor's protocol ID
- 2019/833 (REK)
- Status last verified
- May 2020
- First submitted
- 19 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure in Norway: Combining Artificial Intelligence and a Database of 15000 Patients to Understand Clinical Characteristics, Mortality and Health Care Resource Use
- ClinicalTrials.gov ID
- NCT04398563
- Acronym / sponsor ID
- 2019/833 (REK)
- Conditions
- Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14,998 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 May 2020 (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.
The prevalence of Heart failure above 70 years of age is 10% and 5 year mortality rate above 60%, higher than for cancer. The readmission rate first after hospitalisation is 44% despite the availability of life prolonging and life quality enhancing treatment. There is a lack of resources for adequate diagnostic workup necessary for implementing evidence-based treatment. This projects aims at assessing the impact of guidelines based diagnostic workup and guidelines based treatment of heart failure on mortality and readmission rates. As the symptoms defining the degree of heart failure and the discharge medication only is available in the electronic patient files, artificial intelligence is used to retrieve this information to assess if treatment is according to guidelines.
The project is using first a rule based text processing approach using IBM Watson, then advancing to a machine learning approach using readmission and mortality as endpoints.
The project has access to digitally stored echocardiographic measurements as well as digital ECG's and lab data on 15 000 patients admitted with a diagnosis of Heart failure. If the retrieval of symptoms and function by artificial intelligence is successful, the next step is to assess if those benefitting the most from echocardiography can be identified using information from the ECG's, lab data or symptoms and functional capacity as described in the Electronic Health Records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to a University Hospital serving a population of approx. 600 000 inhabitants with heart failure diagnosis in the period 2007 to 2019. In total 14998 patients. Mortality according to The Norwegian Death Registry for all up until 31st of December 2019. In addition all patients with a diagnosis of COPD in the same period as well as all subjects with NT-proBNP above age specific normal range
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: Change over 12 years
1 year mortality rate after first diagnosis of heart failure
Readmission
Time frame: Change over 12 years
30 days and 1 year readmission rate
2 secondary outcomes
Diagnostic work up according to guidelines
Time frame: Within 6 months before or after first diagnosis
Treatment according to guidelines
Time frame: within first year after first diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
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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.
Henrik Schirmer, MD, PhD principal investigator
University Hospital, Akershus
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 Heart Failure With Preserved Ejection Fraction, run by University Hospital, Akershus at 1 site in Norway.
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 0 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 21 May 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 Norway. 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?
Mortality (time frame: Change over 12 years). The study lists 2 primary outcomes in all. 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 21 May 2020.