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Observational Study of the Cordio HearO System for Heart Failure

This study is observing how well the Cordio HearO System (an app) works for people with heart failure. You might be able to join if you are 22 or older, have symptomatic chronic heart failure (NYHA II-IVa), and have experienced recent heart failure hospitalizations or diuretic treatments, or have a specific biomarker (NTProBNP) level. The study aims to see how well the HearO system can detect heart failure events. We don't have information on the current recruitment status. This is an observational study, meaning you won't receive an intervention beyond using the app for data collection.

Study design
This is an international, observational, blinded, single-arm study with a planned enrollment of 500 participants. It has two periods: a Run-In period and a Core period.
What's involved
You would submit daily voice recordings for up to 24 months or until the study ends. There is a baseline creation during the Run-In period.
Compensation
Not stated in the trial record.
Follow-up
You will be followed up for up to 24 months or until a total of at least 78 first usable and CEC-adjudicated Heart Failure Events (HFEs) have occurred.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06378632

AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM

Recruiting
Not specifiedAges 22+Observational
Cordio Medical
~500 participants
Updated 2025-03-26 on ClinicalTrials.gov
What's tested:Hearo App

At a glance

Recruiting sites
45 of 45 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Heart Failure Events (HFEs)
Measured over EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient

Conditions

Heart Failure

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NCT06378632

Where you'd take part

This study runs at 45 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advance Medical Research Services Corp (AMRS)

    Miami, Floridastudy coordinator listed

    Recruiting

  • Advocate Illinois Masonic Health Center

    Downers Grove, Illinoisstudy coordinator listed

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Amavita Clinical Research

    Miami, Floridastudy coordinator listed

    Recruiting

  • Baptist Health (Miami Cardiac & Vascular Institute)

    Miami, Floridastudy coordinator listed

    Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisianastudy coordinator listed

    Recruiting

  • Cardiovascular Institute of the South

    Lafayette, Louisianastudy coordinator listed

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ronit Haviv, PhD · STUDY_DIRECTOR · Cordio Medical

Who to contact

Bill Tobin
[email protected]
(203) 852-8900
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Heart Failure Events (HFEs)EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient

    Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period 2. Having no Heart Failure Event (HFE) during the entire CORE period