The HUNT for Heart Failure" Risk Score

Active, not recruiting

• Conditions: Heart Failure
• Interventions: Other: Heart failure risk estimation

• Registration Number: NCT04648852
• Lead Sponsor: Helse Nord-Trøndelag HF

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.

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 Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2020-11-24
• Study First Submitted QC: 2020-11-24
• Study First Posted: 2020-12-02
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-13
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 65000

Inclusion Criteria

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

Exclusion Criteria

• Not willing to participate
• Missing vital data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants in the third wave of the HUNT study	Heart failure risk estimation	General population participating in the third wave of the HUNT study
Participants in the second wave of the HUNT study	Heart failure risk estimation	General population participating in the second wave of the HUNT study

Primary Outcome Measures

Name	Time	Method
Time to incident heart failure event	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

Name	Time	Method
Time to death from any cause	10 years	Time to death from any cause
Time to first heart failure event or death from any cause	10 years	Time to first heart failure event (hospitalization or HF related visit at the out-patient clinic) or death from any cause
Validity of heart failure risk score	10 years	Evaluation of the validity of heart failure risk score

Trial Locations

Locations (1)

Levanger hospital; 🇳🇴 Levanger, Norge, Norway