NCT04648852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36,511

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

5.7 years

First QC Date

November 24, 2020

Last Update Submit

June 11, 2025

Conditions

Keywords

risk factorpopulationdiagnosisprognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time to death from any cause

    10 years

  • Time to first heart failure event or death from any cause

    10 years

  • Validity of heart failure risk score

    10 years

Other Outcomes (2)

  • Prevalence of heart failure

    0 days

  • Distribution of heart failure risk score categories

    0 days

Study Arms (2)

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

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

Interventions

Evaluation by heart failure risk score

Participants in the second wave of the HUNT studyParticipants in the third wave of the HUNT study

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population

You may qualify if:

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

You may not qualify if:

  • Not willing to participate
  • Missing vital data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levanger hospital

Levanger, Norge, 7600, Norway

Location

Related Publications (1)

  • 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.

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

MeSH Terms

Conditions

Heart FailureDisease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Håvard Dalen, MSc, PhD

    Helse Nord-Trøndelag HF

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2020

First Posted

December 2, 2020

Study Start

October 1, 2017

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

June 15, 2025

Record last verified: 2025-06

Locations