Recruiting

Heart Failure Indicators

Sponsor:

Noah Labs

Code:

NCT06566911

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06566911

Start date

Jan 24, 2024

Status verified date

Aug, 2024

Completion date

Sep, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Leonhard Riehle, MD

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55902

More Information

Sponsor

Noah Labs

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Noah Labs on 2024-08-22.