Voice Analysis for Monitoring Patients With Heart Failure

NCT06566911 | Recruiting

• 1 other identifier: 23-011322
• Study Type: observational
• Target: 70
• Locations: 2 countries
• Sites: 2

Brief Summary

This observational study involves ADHF patients at two sites in the United States and Germany. After informed consent and screening assessments, participants will perform daily voice recordings during their hospital stay, from admission until discharge. Alongside voice data, additional clinical information such as left ventricular ejection fraction, NTpro-BNP levels, and ECG-data will be collected for comprehensive analysis. The study's goal is to identify voice-based indicators of heart failure progression, with the potential to enhance remote monitoring and self-management strategies for heart failure patients.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.

  The primary endpoint is the change in vocal characteristics from admission to discharge, and its correlation with clinical markers of heart failure severity, such as weight change from admission to discharge, NTpro-BNP levels, ECG-parameters, and left ventricular ejection fraction (LVEF).

  Hospital stay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients, aged 18 and older, hospitalized with acutely decompensated heart failure, irrespective of left ventricular ejection fraction.

You may qualify if:

• Clinically diagnosed with Acutely Decompensated Heart Failure.
• At least 18 years of age.

You may not qualify if:

• Disabling mental diseases (e.g., Alzheimer's disease)
• Clinically diagnosed chronic obstructive pulmonary disease (COPD)
• Treatment in ICU or IMU
• Dialysis treatment
• Previous operations on organs involved in generation of voice (vocal tract, vocal folds, etc.)
• Neurodegenerative diseases
• Pregnancy
• Inability to provide consent

Sponsors & Collaborators

• Noah Labs: lead
• Charite University, Berlin, Germany: collaborator
• Mayo Clinic: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

RECRUITING

Deutsches Herzzentrum der Charité

Berlin, 13353, Germany

COMPLETED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gerhard Hindricks, MD

  German Heart Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonhard Riehle, MD

CONTACT

+49 32 221093495; leonhard.riehle@noah-labs.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 22, 2024
• Study Start: January 24, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

DE (1); US (1)