Voice Analysis for Monitoring Patients With Heart Failure

NCT ID: NCT06566911

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-24

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role collaborator

Noah Labs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerhard Hindricks, MD

Role: PRINCIPAL_INVESTIGATOR

German Heart Institute

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Deutsches Herzzentrum der Charité

Berlin, , Germany

Site Status COMPLETED

Countries

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United States Germany

Central Contacts

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Leonhard Riehle, MD

Role: CONTACT

+49 32 221093495

Facility Contacts

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Soumya Vungarala, MD

Role: primary

Other Identifiers

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23-011322

Identifier Type: -

Identifier Source: org_study_id

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