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

NCT07443969 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 123

Last updated 2026-03-02

No results posted yet for this 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.

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Maastricht University

    collaborator OTHER

  • Zuyderland Medical Centre

    collaborator OTHER

  • Noah Labs

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Netherlands
  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07443969 on ClinicalTrials.gov