The HUNT for Heart Failure" Risk Score (HUNT4HF)

• ClinicalTrials.gov Identifier: NCT04648852
• Recruitment Status: Active, not recruiting
• First Posted: December 2, 2020
• Last Update Posted: November 9, 2021
• Sponsor: Helse Nord-Trøndelag HF
• Collaborators: Boehringer Ingelheim; Norwegian University of Science and Technology; Vestre Viken Hospital Trust
• Information provided by (Responsible Party): Helse Nord-Trøndelag HF

Study Description

Brief 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. Additionally, the prevalence of heart failure as well as the distribution of the heart failure risk score in the general population will be evaluated.

Condition or disease	Intervention/treatment
Heart Failure	Other: Heart failure risk estimation

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

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 65000 participants
• Observational Model: Ecologic or Community
• Time Perspective: Prospective
• Target Follow-Up Duration: 20 Years
• Official Title: Heart Failure Burden and Heart Failure Risk in the General Population in Norway: "The HUNT for Heart Failure" Risk Score
• Actual Study Start Date: October 1, 2017
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Participants in the third wave of the HUNT study; General population participating in the third wave of the HUNT study	Other: Heart failure risk estimation; Evaluation by heart failure risk score
Participants in the second wave of the HUNT study; General population participating in the second wave of the HUNT study	Other: Heart failure risk estimation; Evaluation by heart failure risk score

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. Time to death from any cause [ Time Frame: 10 years ]
   Time to death from any cause
2. Time to first heart failure event or death from any cause [ Time Frame: 10 years ]
   Time to first heart failure event (hospitalization or HF related visit at the out-patient clinic) or death from any cause
3. Validity of heart failure risk score [ Time Frame: 10 years ]
   Evaluation of the validity of heart failure risk score

Other Outcome Measures:

1. Prevalence of heart failure [ Time Frame: 0 days ]
   Prevalence of heart failure in a general population
2. Distribution of heart failure risk score categories [ Time Frame: 0 days ]
   Distribution of the heart failure risk score categories in a general population

Biospecimen Retention:   Samples With DNA

Biobank available, but not included in this project. Laboratory test made available are haematology overview, renal function serology, C-reactive protein

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

General population

Criteria

Inclusion Criteria:

• Participation in the third or second wave of the HUNT study

Exclusion Criteria:

• Not willing to participate
• Missing vital data

Contacts and Locations

Locations

Norway

Levanger hospital

Levanger, Norge, Norway, 7600

Sponsors and Collaborators

Helse Nord-Trøndelag HF

Boehringer Ingelheim

Norwegian University of Science and Technology

Vestre Viken Hospital Trust

Investigators

• Study Chair: Håvard Dalen, MSc, PhD; Helse Nord-Trøndelag HF

More Information

• Responsible Party: Helse Nord-Trøndelag HF
• ClinicalTrials.gov Identifier: NCT04648852
• Other Study ID Numbers: LH-20H4HF
• First Posted: December 2, 2020
• Last Update Posted: November 9, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Will follow the institutional regulations

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helse Nord-Trøndelag HF:

risk factor; population; diagnosis; prognosis

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases