The HUNT for Heart Failure" Risk Score

Heart Failure Clinical Trial

— HUNT4HF  

Official title:

Heart Failure Burden and Heart Failure Risk in the General Population in Norway: "The HUNT for Heart Failure" Risk Score

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04648852
• Other study ID #: LH-20H4HF
• Status: Active, not recruiting
• Start date: October 1, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2023
• Source: Helse Nord-Trøndelag HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65000
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not willing to participate

• Missing vital data

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Heart failure risk estimation
Evaluation by heart failure risk score

Locations

Country	Name	City	State
Norway	Levanger hospital	Levanger	Norge

Sponsors (4)

Lead Sponsor	Collaborator
Helse Nord-Trøndelag HF	Boehringer Ingelheim, Norwegian University of Science and Technology, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of heart failure	Prevalence of heart failure in a general population	0 days
Other	Distribution of heart failure risk score categories	Distribution of the heart failure risk score categories in a general population	0 days
Primary	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	Time to death from any cause	Time to death from any cause	10 years
Secondary	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
Secondary	Validity of heart failure risk score	Evaluation of the validity of heart failure risk score	10 years