The HUNT for Heart Failure" Risk Score (HUNT4HF)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 65000

Contacts and Locations

Study Locations

• Norway
  • Norge
    • Levanger, Norge, Norway, 7600
      • Levanger Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

General population

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Not willing to participate
• Missing vital data

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to death from any cause	Time to death from any cause	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	10 years
Validity of heart failure risk score	Evaluation of the validity of heart failure risk score	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of heart failure	Prevalence of heart failure in a general population	0 days
Distribution of heart failure risk score categories	Distribution of the heart failure risk score categories in a general population	0 days

Collaborators and Investigators

• Sponsor: Helse Nord-Trøndelag HF
• Collaborators: Vestre Viken Hospital Trust; Norwegian University of Science and Technology; Boehringer Ingelheim
• Investigators: Study Chair: Håvard Dalen, MSc, PhD, Helse Nord-Trøndelag HF

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Estimate): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: prognosis; diagnosis; risk factor; population
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: LH-20H4HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will follow the institutional regulations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No