Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:03 AM
Study NCT ID:
NCT07443969
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2024-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-Symptomatic Detection of Impending Decompensation in Heart Failure Through Voice Data
Sponsor:
Noah Labs
Organization:
Study Overview
Official Title:
Pre-Symptomatic Detection of Impending Decompensation in Heart Failure Through
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRE-DETECT-HF
Brief 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.
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.
Detailed Description:
Heart failure decompensation is often detected too late by conventional symptom and weight monitoring, leaving insufficient time to intervene. Invasive alternatives such as implantable pulmonary artery pressure monitors are effective but require surgical implantation. Voice-based digital biomarkers offer a promising non-invasive approach, as fluid overload may produce detectable changes in vocal features.
Patients begin voice recordings during hospitalization while still volume overloaded. At home, patients record daily using standardized and variable text content. The voice-based algorithm extracts biomechanical vocal features and calculates a risk score.
Healthcare providers access a dashboard showing symptom-based notifications and may adjust therapy at their discretion. Voice-derived risk scores are withheld during the study and analyzed retrospectively.
Study visits occur at months 3 and 6 (in-clinic) and month 1 (telephone). Blood samples are collected at baseline, month 3, and month 6 for analysis of traditional (NT-proBNP, creatinine) and novel biomarkers. Usability and quality of life are assessed via questionnaires distributed throughout the study period.
Patients begin voice recordings during hospitalization while still volume overloaded. At home, patients record daily using standardized and variable text content. The voice-based algorithm extracts biomechanical vocal features and calculates a risk score.
Healthcare providers access a dashboard showing symptom-based notifications and may adjust therapy at their discretion. Voice-derived risk scores are withheld during the study and analyzed retrospectively.
Study visits occur at months 3 and 6 (in-clinic) and month 1 (telephone). Blood samples are collected at baseline, month 3, and month 6 for analysis of traditional (NT-proBNP, creatinine) and novel biomarkers. Usability and quality of life are assessed via questionnaires distributed throughout the study period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: