Heart FailureHUNT4HFNCT04648852
The HUNT for Heart Failure" Risk Score
An observational study of Heart Failure, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial summary
In this population study aim is to evaluate risk factors for heart failure and combine these into a new heart failure risk score. Secondly, the heart failure risk score will be internally and externally validated, and compared with established heart failure risk scores. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart failure risk estimation
- How many people
- 36,511 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2017to 30 Jun 2023
- How long will I take part?
- 20 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population
Who may be able to join
- Participation in the third or second wave of the HUNT study
Who cannot join
- Not willing to participate
- Missing vital data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Failure Burden and Heart Failure Risk in the General Population in Norway: "The HUNT for Heart Failure" Risk Score
In this population study aim is to evaluate risk factors for heart failure and combine these into a new heart failure risk score.
Secondly, the heart failure risk score will be internally and externally validated, and compared with established heart failure risk scores. Additionally, the prevalence of heart failure as well as the distribution of the heart failure risk score in the general population will be evaluated.
Read the detailed description
Explore which clinical risk factors or patient characteristics in a general population that are associated with increased risk for heart failure events and combine these into a new population-based heart failure risk score ("The HUNT for heart failure risk score") for predicting heart failure risk
Validate the newly developed heart failure risk score internally in the HUNT2 database
Compare the predictive ability of the new heart failure risk score with established heart failure risk scores (the ABC Health HF risk score, the Framingham HF risk score) and an established Norwegian cardiovascular risk score (NORRISK 2)
Estimate the prevalence of likely ("undiagnosed") heart failure , i.e., patients at high risk of HF, in a general population by using both the established heart failure risk scores and the newly developed heart failure risk score, and compare the heart failure event rate between those at high risk of heart failure and those with established heart failure.
- Conditions
- Heart Failure
- Being tested
- Heart failure risk estimation
- Keywords
- risk factor, population, diagnosis, prognosis
- Medical subject headings
- Heart Failure, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart failure risk estimationOther
Evaluation by heart failure risk score
| Study group | Role | What they receive |
|---|---|---|
| Participants in the third wave of the HUNT study | General population participating in the third wave of the HUNT study Receives: Other: Heart failure risk estimation | |
| Participants in the second wave of the HUNT study | General population participating in the second wave of the HUNT study Receives: Other: Heart failure risk estimation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to incident heart failure event
Time to first heart failure hospitalization or heart failure related visit at the out-patient clinic (events defined according to the ESC 2016 heart failure guidelines)
Measured: 10 years
Secondary outcomes (3)
Time to death from any cause
Time to death from any cause
Measured: 10 years
Time to first heart failure event or death from any cause
Time to first heart failure event (hospitalization or HF related visit at the out-patient clinic) or death from any cause
Measured: 10 years
Validity of heart failure risk score
Evaluation of the validity of heart failure risk score
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Oct 2017
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 36,511 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Norwegian University of Science and Technology, Vestre Viken Hospital Trust
- Responsible party
- Sponsor
- Investigators
- Håvard Dalen, MSc, PhD, Study chair, Helse Nord-Trøndelag HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648852
- Sponsor's protocol ID
- LH-20H4HF
- Acronym
- HUNT4HF
- Status last verified
- Jun 2025
- First submitted
- 24 Nov 2020
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will follow the institutional regulations
Publications
Ofstad AP, Brunborg C, Johansen OE, Morkedal B, Fagerland MW, Laugsand LE, Gullestad LL, Dalen H. Development of a tool to predict the risk of incident heart failure in a general population: the HUNT for HF risk score. ESC Heart Fail. 2023 Oct;10(5):2807-2815. doi: 10.1002/ehf2.14390. Epub 2023 May 29.
PubMed 37248650
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Burden and Heart Failure Risk in the General Population in Norway: "The HUNT for Heart Failure" Risk Score
- ClinicalTrials.gov ID
- NCT04648852
- Acronym / sponsor ID
- HUNT4HF / LH-20H4HF
- Conditions
- Heart Failure
- Keywords
- risk factor, population, diagnosis, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,511 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Norwegian University of Science and Technology, Vestre Viken Hospital Trust
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Dec 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.
In this population study aim is to evaluate risk factors for heart failure and combine these into a new heart failure risk score.
Secondly, the heart failure risk score will be internally and externally validated, and compared with established heart failure risk scores. Additionally, the prevalence of heart failure as well as the distribution of the heart failure risk score in the general population will be evaluated.
Detailed description
Explore which clinical risk factors or patient characteristics in a general population that are associated with increased risk for heart failure events and combine these into a new population-based heart failure risk score ("The HUNT for heart failure risk score") for predicting heart failure risk
Validate the newly developed heart failure risk score internally in the HUNT2 database
Compare the predictive ability of the new heart failure risk score with established heart failure risk scores (the ABC Health HF risk score, the Framingham HF risk score) and an established Norwegian cardiovascular risk score (NORRISK 2)
Estimate the prevalence of likely ("undiagnosed") heart failure , i.e., patients at high risk of HF, in a general population by using both the established heart failure risk scores and the newly developed heart failure risk score, and compare the heart failure event rate between those at high risk of heart failure and those with established heart failure.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants in the third wave of the HUNT study | – | Other: Heart failure risk estimationGeneral population participating in the third wave of the HUNT study |
| Participants in the second wave of the HUNT study | – | Other: Heart failure risk estimationGeneral population participating in the second wave of the HUNT study |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (1 listed)
- Participation in the third or second wave of the HUNT study
Key exclusion criteria (2 listed)
- Not willing to participate
- Missing vital data
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 risk estimationEvaluation by heart failure risk score | Other | Participants in the second wave of the HUNT study, Participants in the third wave of the HUNT study |
Primary outcome
Time to incident heart failure event
Time frame: 10 years
Time to first heart failure hospitalization or heart failure related visit at the out-patient clinic (events defined according to the ESC 2016 heart failure guidelines)
3 secondary outcomes
Time to death from any cause
Time frame: 10 years
Time to first heart failure event or death from any cause
Time frame: 10 years
Validity of heart failure risk score
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 37248650Ofstad AP, Brunborg C, Johansen OE, Morkedal B, Fagerland MW, Laugsand LE, Gullestad LL, Dalen H. Development of a tool to predict the risk of incident heart failure in a general population: the HUNT for HF risk score. ESC Heart Fail. 2023 Oct;10(5):2807-2815. doi: 10.1002/ehf2.14390. Epub 2023 May 29.
- Individual participant dataSharing planned: Undecided. Will follow the institutional regulations
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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.
Håvard Dalen, MSc, PhD study chair
Helse Nord-Trøndelag HF
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 Helse Nord-Trøndelag HF 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 15 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to incident heart failure event (time frame: 10 years). 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 NCT04648852, which also lists 1 linked publication.
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 15 Jun 2025.