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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04398563
• Other study ID #: 2019/833 (REK)
• Status: Active, not recruiting
• Start date: January 20, 2020
• Est. completion date: December 2023

Study information

• Verified date: May 2020
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14998
• Est. completion date: December 2023
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Heart Failure With Reduced Ejection Fraction

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Akershus	Novartis

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	1 year mortality rate after first diagnosis of heart failure	Change over 12 years
Primary	Readmission	30 days and 1 year readmission rate	Change over 12 years
Secondary	Diagnostic work up according to guidelines	Proportion with echocardiography and other necessary investigations	Within 6 months before or after first diagnosis
Secondary	Treatment according to guidelines	Proportion treated according to guidelines	within first year after first diagnosis