NCT07443969Active, not recruiting
Pre-Symptomatic Detection of Impending Decompensation in Heart Failure Through Voice Data
Pre-Symptomatic Detection of Impending Decompensation in Heart Failure Through
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 123 (estimated)
- First submitted
- 25 Jan 2024
- Start date
- 9 Jan 2025
- Primary completion date
- Jun 2026
- Lead sponsor
- Noah Labs
- Diseases
- Heart failure
- NCT number
- NCT07443969
What you commit to
- Study type: Observational
- Planned participants: 123
- From 9 Jan 2025 to the primary completion date, Jun 2026
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous operations on organs involved in generation of voice (vocal tract, vocal folds, etc.)
Other illness
- 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
Other
- Inability to provide consent
- Pregnancy
- Inability to use a smartphone or a tablet computer despite support by informal caregiver if required
- Insufficient knowledge of the local language
- Participation in another interventional study within 30 days of inclusion
Who the study is looking for
- Informed consent provided
- Currently hospitalized for acutely decompensated HF or de-novo HF
- Age: 18 years and above
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Zuyderland Medical Centre Coordinator of this site? Confirm its status | Heerlen | Netherlands | Unknown status |
| Maastricht University Medical Centre Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.