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Recruiting NCT06566911

Voice Analysis for Monitoring Patients With Heart Failure

Observational Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Change in vocal characteristics from admission to discharge and their correlation with heart failure severity markers. [Time frame: Hospital stay]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Mayo Clinic — Rochester
Germany · 1 center
  • Deutsches Herzzentrum der Charité — Berlin

Identifiers

NCT: NCT06566911 · 23-011322

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗