Heart Failure in Norway: Clinical Characteristics, Mortality and Health Care Resource Use

Heart Failure in Norway: Combining Artificial Intelligence and a Database of 15000 Patients to Understand Clinical Characteristics, Mortality and Health Care Resource Use

The prevalence of Heart failure above 70 years of age is 10% and 5 year mortality rate above 60%, higher than for cancer. The readmission rate first after hospitalisation is 44% despite the availability of life prolonging and life quality enhancing treatment. There is a lack of resources for adequate diagnostic workup necessary for implementing evidence-based treatment. This projects aims at assessing the impact of guidelines based diagnostic workup and guidelines based treatment of heart failure on mortality and readmission rates. As the symptoms defining the degree of heart failure and the discharge medication only is available in the electronic patient files, artificial intelligence is used to retrieve this information to assess if treatment is according to guidelines.

The project is using first a rule based text processing approach using IBM Watson, then advancing to a machine learning approach using readmission and mortality as endpoints.

The project has access to digitally stored echocardiographic measurements as well as digital ECG's and lab data on 15 000 patients admitted with a diagnosis of Heart failure. If the retrieval of symptoms and function by artificial intelligence is successful, the next step is to assess if those benefitting the most from echocardiography can be identified using information from the ECG's, lab data or symptoms and functional capacity as described in the Electronic Health Records.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure With Preserved Ejection Fraction

• Study Type: Observational
• Enrollment (Actual): 14998

Contacts and Locations

Study Locations

• Norway
  • Lørenskog, Norway
    • Akershus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients admitted to a University Hospital serving a population of approx. 600 000 inhabitants with heart failure diagnosis in the period 2007 to 2019. In total 14998 patients. Mortality according to The Norwegian Death Registry for all up until 31st of December 2019. In addition all patients with a diagnosis of COPD in the same period as well as all subjects with NT-proBNP above age specific normal range

Description

Inclusion Criteria: Diagnosis with ICD10 codes as follows; I50.*, I42.3, I11.* and COPD J44.* from 2007 through 2019.

In addition all subjects with NT-proBNP above age specific normal range in same period.

Exclusion Criteria:

none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	1 year mortality rate after first diagnosis of heart failure	Change over 12 years
Readmission	30 days and 1 year readmission rate	Change over 12 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic work up according to guidelines	Proportion with echocardiography and other necessary investigations	Within 6 months before or after first diagnosis
Treatment according to guidelines	Proportion treated according to guidelines	within first year after first diagnosis

Collaborators and Investigators

• Sponsor: University Hospital, Akershus
• Collaborators: Novartis
• Investigators: Principal Investigator: Henrik Schirmer, MD, PhD, University Hospital, Akershus

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 19, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2019/833 (REK)

Drug and device information, study documents

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