Voice Analysis for Monitoring Patients With Heart Failure (VAMP-HF)

August 19, 2024 updated by: Noah Labs

A Pilot Study on AI-Based Voice Analysis for Monitoring Patients Hospitalized With Acute Decompensated Heart Failure

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Completed
        • Deutsches Herzzentrum der Charité
  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Soumya Vungarala, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers.
Time Frame: Hospital stay
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noah Labs

Collaborators

Mayo Clinic
Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Gerhard Hindricks, MD, German Heart Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-011322

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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