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Clinical Trials in Spain / NCT07443969
Active, not recruiting Observational

Pre-Symptomatic Detection of Impending Decompensation in Heart Failure Through Voice Data

NCT07443969 · tracked via the Priya Life Science Spain tracker
Sponsor
Noah Labs
Phase
Observational
Started
2025-01-09
Last updated
2026-03-02

Condition(s) studied

Heart FailureChronic Heart FailureChronic Heart Disease

Investigational drug(s) / intervention(s)

Daily Voice Recording and Symptom Monitoring

Daily Voice Recording and Symptom Monitoring: Patients use the mobile app daily to record voice samples and answer symptom-related questions. Voice recordings are analyzed by a algorithm, which extracts vocal biomechanical features. Healthcare providers receive notifications based on symptom data only and may adjust therapy at their discretion. Voice-derived risk scores are not shared with clinicians during the study and are analyzed retrospectively after study completion.

Study summary

PRE-DETECT-HF is a prospective, single-arm observational study evaluating a voice-based machine learning algorithm for early detection of heart failure decompensation. 123 patients hospitalized for acute decompensated or de-novo heart failure will be enrolled across three sites in the Netherlands and Spain.

Patients make daily voice recordings via a smartphone app and answer symptom questions for 6 months. The algorithm analyzes voice patterns compared to a baseline recording at discharge. Treatment decisions are based on symptom data only; voice-based predictions are analyzed retrospectively after study completion.

The primary endpoint is sensitivity of the voice-based software in detecting heart failure deterioration, defined as heart failure hospitalization, or intensification of heart failure therapy. Secondary endpoints include app adherence, usability, and associations between voice data and blood biomarkers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Informed consent provided * Currently hospitalized for acutely decompensated HF or de-novo HF * Age: 18 years and above Exclusion Criteria: * Inability to provide consent * Pregnancy * Life-expectancy lower than 1 year due to a condition other than HF * Planned cardiac intervention within the next 6 months (e.g. valve replacement, bypass surgery) * Disabling mental diseases (e.g., Alzheimer's disease) * Symptoms mainly caused by chronic disease other than HF such as chronic obstructive pulmonary disease * Inability to use a smartphone or a tablet computer despite support by informal caregiver if required * Insufficient knowledge of the local language * Previous operations on organs involved in generation of voice (vocal tract, vocal folds, etc.) * Participation in another interventional study within 30 days of inclusion

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Zuyderland Medical Centre Heerlen Netherlands
Maastricht University Medical Centre Maastricht Netherlands
Hospital Clínic de Barcelona Barcelona Spain

Other trials for the same condition

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation Active, not recruiting
Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction Recruiting
A Research Study to Look at How Well NNC0487-0111 Works Compared to Placebo in People With Heart Failure and Obesity Recruiting
Atrial Fibrillation Ablation Versus Atrioventricular Nodal Ablation with Conduction System Pacing in Heart Failure Recruiting
Integrated Approach in Frail Older People with Atrial Fibrillation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07443969 on ClinicalTrials.gov ↗ ← All trials in Spain