Pre-Symptomatic Detection of Impending Decompensation in Heart Failure through Voice Data (PRE-DETECT-HF)

Pre-Symptomatic Detection of Impending Decompensation in Heart Failure through Voice Data (PRE-DETECT-HF) - PRE-DETECT-HF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57126

Enrollment

Registered

2024-05-27

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart congestion heart failure

Interventions

Recording of structured voice samples with a combination of pre-defined text samples and a variable content to avoid boredom daily for about 2 minutes. The variable content will be related to genera

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Informed consent provided - Currently hospitalized for acutely decompensated HF or de-novo HF - Age: >18 years

Exclusion criteria

Exclusion criteria: - Inability to provide consent - Pregnancy - Life-expectancy

Design outcomes

Primary

Measure	Time frame
The primary objective is to validate the voice-based decompensation prediction software in predicting heart failure deterioration in patients discharged after admission due to decompensated heart failure. The primary endpoint of the study is deterioration of heart failure. Deterioration of heart failure is defined as: - Cardiovascular mortality - Heart failure related hospitalisation - Intensifying heart failure therapy due worsening of heart failure according to the assessment of the investigators and/or treating physician, i.e. typically intensifying diuretic therapy (either iv. or for at least 2 days), but may also include e.g. MRA or SGLT2-inhibition. Uptitration of therapy as standard HF treatment is not considered as endpoint.	—

Measure

Time frame

The primary objective is to validate the voice-based decompensation prediction software in predicting heart failure deterioration in patients discharged after admission due to decompensated heart failure. The primary endpoint of the study is deterioration of heart failure. Deterioration of heart failure is defined as: - Cardiovascular mortality - Heart failure related hospitalisation - Intensifying heart failure therapy due worsening of heart failure according to the assessment of the investigators and/or treating physician, i.e. typically intensifying diuretic therapy (either iv. or for at least 2 days), but may also include e.g. MRA or SGLT2-inhibition. Uptitration of therapy as standard HF treatment is not considered as endpoint.

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Secondary

Measure	Time frame
There are two main seconday objectives in this study: Firstly, the study will systematically evaluate both patient adherence to, and the user-friendliness of the newly developed software application. It is also relevant in this context to evaluate the effect of Quality of Life on the adherence and usability (15). Secondly, the association of voice outcomes with well-established and novel blood biomarkers will be investigated. To achieve the secondary objective, the study will assess the following endpoints: • Adherence will be evaluated by registring the number and percentage of days on which at least one voice recording is transmitted to the application • Usability will be evaluated using questionnaires and interviews, where user experiences and expectations could be analysed. • The influence of Quality of Life on adherence and usibility will be assessed by combining the Kansas City Cardiomyopathy Questionnaire (KCCQ) (15) outcomes with the quantitative results of adherence, which could be substatiated using usibility outcomes. And; • Laboratory results (if clinically indicated, results of clinical routine will be used; otherwise, the blood biomarkers will be obtained as part of the study): creatinine, potassium, sodium, urea, NT-proBNP	—

Measure

Time frame

There are two main seconday objectives in this study: Firstly, the study will systematically evaluate both patient adherence to, and the user-friendliness of the newly developed software application. It is also relevant in this context to evaluate the effect of Quality of Life on the adherence and usability (15). Secondly, the association of voice outcomes with well-established and novel blood biomarkers will be investigated. To achieve the secondary objective, the study will assess the following endpoints: • Adherence will be evaluated by registring the number and percentage of days on which at least one voice recording is transmitted to the application • Usability will be evaluated using questionnaires and interviews, where user experiences and expectations could be analysed. • The influence of Quality of Life on adherence and usibility will be assessed by combining the Kansas City Cardiomyopathy Questionnaire (KCCQ) (15) outcomes with the quantitative results of adherence, which could be substatiated using usibility outcomes. And; • Laboratory results (if clinically indicated, results of clinical routine will be used; otherwise, the blood biomarkers will be obtained as part of the study): creatinine, potassium, sodium, urea, NT-proBNP

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Countries

Netherlands, Spain

Contacts

Public ContactHP Brunner-La Rocca

Maastricht Universitair Medisch Centrum +

hp.brunnerlarocca@mumc.nl043-3877097

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026