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Heart FailureDETECT-HFNCT06378632

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

An observational study of Heart Failure, run by Cordio Medical at 45 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Study Design: This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system. Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Heart Failure
What is being tested?
Hearo App
Type of treatment
Medical device
How many people
500 participants
Where
45 sitesin 3 countries
Study dates
11 Feb 2022to 15 Jul 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Outpatient clinics

Major Inclusion Criteria:

  1. Age 22 or greater
  2. Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]
  3. At least one of the following:
  4. One ADHF hospitalization in the last 12 months
  5. One unplanned IV/SC diuretic administration in the last 6 months
  6. Two unplanned IV/SC diuretic administrations in the last 12 months
  7. NTProBNP >500 pg/ml
  8. Clinically stable HF according to investigator discretion
  9. Willing to participate as evidenced by signing the written informed consent.

Major Exclusion Criteria:

  1. Unable to comply with daily use of the App,
  2. Has had a major cardiovascular event within 3 months prior to enrolment.
  3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
  4. Has estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73.
  5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
  6. Was treated for a significant COPD

Trial locations and contacts

45 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Bill Tobin contact

(203) 852-8900

billt@ihcresearch.com

45 sites in 3 countries

United States37 sites, 37 recruiting

  • Mission Hospital

    Asheville, North Carolina, 28803

    Josephine Purbrick, SC, (828) 412-9149, josephine.purbrick@sarahcannon.com

    Vinay Thohan, MD

    Recruiting

  • West Georgia Cardiology

    Carrollton, Georgia, 30117

    Justina Okeke, SC, (678) 839-7285, justina.okeke@westgacardiology.com

    Charlie Rouse, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Veronica Herzog, SC, (773) 834-9794, vherzog@bsd.uchicago.edu

    Gene Kim, MD

    Recruiting

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

    Maci Eiber, SC, (773) 296-0969, maci.eiber@aah.org

    Sorin Danciu, MD

    Recruiting

  • The Lindner Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219

    Kathryn Gloria, SC, katherineaubre.glori@thechristhospital.com

    Eugene Chung, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44106

    Savi Radesic, (216) 445-6916, radesis@ccf.org

    W.H. Wilson Tang, MD

    Recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Carina Pannelle, (614) 366-8650, carina.panelle@osumc.edu

    Rami Kahwash, MD

    Recruiting

  • Nature Coast Clinical Research

    Crystal River, Florida, 34429

    Nina Smith, SC, (352) 563-1865, nsmith@encoredocs.com

    Susan Pasupuleti, MD

    Recruiting

  • Advocate Illinois Masonic Health Center

    Downers Grove, Illinois, 60515

    Debra Heidenreich, SC, (630) 352-2338, debra.heidenreich@aah.org

    Sorin Danciu, MD

    Recruiting

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

    Cynthia Mulcahy, SC, (859) 301-4046, cynthia.mulcahy@stelizabeth.com

    Haree Vongooru, MD

    Recruiting

  • Eastern Shore Research Institute

    Fairhope, Alabama, 36532

    Jessica Huckleberry, SC, (251) 990-1920, jessicahuckleberry@yahoo.com

    Michael Pursley, MD

    Recruiting

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27401

    Michelle McCart, SC, (336) 832-3799, michelle.mccart@conehealth.com

    Daniel Bensimhon, MD

    Recruiting

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

    Kimberly Lirette, SC, (985) 873-5619, kimberly.lirette@cardio.com

    Peter Fail, MD

    Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

    Taylor Johnson, SC, (904) 730-0101, tjohnson@encoredocs.com

    Michael Koren, MD

    Recruiting

  • UC San Diego Health

    La Jolla, California, 92037

    Joshua Gillman, SC, (858) 246-2511, j1gillman@health.ucsd.edu

    Nicholas Wettersten, MD

    Recruiting

  • Cardiovascular Institute of the South

    Lafayette, Louisiana, 70503

    June Jones, SC, (337) 289-8429, june.jones@cardio.com

    Wade May, MD

    Recruiting

  • Nebraska Heart Center

    Lincoln, Nebraska, 68526

    Julie Potter, SC, (402) 328-3950, julie.potter@commonspirit.org

    Steven Krueger, MD

    Recruiting

  • VA Loma Linda Healthcare System

    Loma Linda, California, 92357

    Vicki Simpson, SC, (909) 593-6361, vicki.simpson@va.gov

    Jay Patel, MD

    Recruiting

  • Rio Grande Regional Hospital

    McAllen, Texas, 78503

    Dina Garcia, SC, (956) 632-6054, dina.garcia2@hcahealthcare.com

    Norman Ramirez, MD

    Recruiting

  • Amavita Clinical Research

    Miami, Florida, 33137

    Nereisy Alonso, SC, (786) 703-5941, researchadmin@amavita.health

    Pedro Martinez Clark, MD

    Recruiting

  • Advance Medical Research Services Corp (AMRS)

    Miami, Florida, 33173

    Adam Rachid, SC, (305) 928-8845, arachid.amrs@gmail.com

    Yordan Orive Gomez, MD

    Recruiting

  • Baptist Health (Miami Cardiac & Vascular Institute)

    Miami, Florida, 33173

    Margie Mckercher, SC, (786) 595-8075, margie.mchercher@baptisthealth.net

    Sandra Chaparro, MD

    Recruiting

  • Midwest Cardiovascular Center

    Naperville, Illinois, 60540

    Josilyn Klimek, SC, (630) 600-0730, josilyn.klimek@cardio.com

    Maria Rosa Costanzo, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Terry Weyand, SC, (615) 322-9349, terry.l.weyand@vumc.org

    JoAnn Lindenfeld, MD

    Recruiting

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

    Katasha Washington, SC, (504) 702-4704, katasha.washington@lcmchealth.org

    Frank Smart, MD

    Recruiting

  • Mount Sinai Morningside

    New York, New York, 10025

    Kathy Idrissi, SC, (646) 561-1170, katharine.idrissi2@mountsinai.org

    Kiran Mahmood, MD

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Lovelyne Julien, SC, (212) 241-1537, lovelyne.julien@mountsinai.org

    Anuradha Lala - Trindade, MD

    Recruiting

  • VA Southern Nevada Healthcare System

    North Las Vegas, Nevada, 89086

    Rosalinda Cruz, SC, (702) 791-9000 ext. 15575, Rosalinda.cruz@va.gov

    Marriyam Moten, MD

    Recruiting

  • Comprehensive Medical & Research Center

    Plantation, Florida, 33317

    Wilmer Santiesteban Garcia, SC, (954) 368-3529, wsantiesteban@compmedical.net

    William Korey, MD

    Recruiting

  • St. Francis Hospital

    Roslyn, New York, 11576

    Lyn Santiago, SC, (516) 562-6763, lyn.santiago@chsli.org

    Rita Jermyn, MD

    Recruiting

  • St. Johns Center for Clinical Research

    Saint Augustine, Florida, 32086

    Valerie Hayes, SC, (904) 209-0043, vhayes@encoredocs.com

    Ameeth Vedre, MD

    Recruiting

  • Methodist Hospital of San Antonio

    San Antonio, Texas, 78229

    Maurene Cantu, (210) 218-4950, maurene.cantu@hcahealthcare.com

    Sachin Gupta, MD

    Recruiting

  • VA San Diego

    San Diego, California, 92161

    Jonathan Narita, SC, (858) 642-3512, jonathan.narita@va.gov

    Nancy Gardetto, MD

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94117

    Priscilla Zhang, SC, (415) 514-7903, priscilla.zhang@ucsf.edu

    Liviu Klein, MD

    Recruiting

  • Kaiser Permanente San Francisco

    San Francisco, California, 94118

    Priscilla Chung, SC, (415) 833-3480, priscilla.s.chung@kp.org

    Jana Svetlichanaya, MD

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Kiria Almeida-Tamayo, SC, (813) 844-8058, kalmeidatamayo@tgh.org

    Debbie Hoffman, MD

    Recruiting

  • Robert J. Dole VA Medical Center

    Wichita, Kansas, 67218

    Deborah Garner, sc, (316) 685-2221 ext. 53352, deborah.garner@va.gov

    Freidy Eid, MD

    Recruiting

Other trials in United States

Israel7 sites, 7 recruiting

  • University Hospital Samson Assuta Ashdod

    Ashdod

    Sapir Swisa, SC

    Alexander Goldman, MD

    Recruiting

  • Assuta Be'er Sheva Medical Center

    Beersheba

    Alex Demitriev, SC

    Amos Katz, MD

    Recruiting

  • Rambam Medical Center

    Haifa

    Ludmila Helmer, SC, 972-4-7773475

    Oren Caspi, MD

    Recruiting

  • Shaare Zedek Medical Center

    Jerusalem

    Hadas Barda, SC, 972-2-6666769

    Tal Hasin, MD

    Recruiting

  • Galiee Medical Center

    Nahariya

    Etti Lasri Kadosh, SC, 972-4-9107747

    Shaul Atar, MD

    Recruiting

  • Tel Aviv Sourasky (Ichilov) Medical Center

    Tel Aviv

    Tal Fux, SC, 972-3-6972420

    Michal Laufer Perl, MD

    Recruiting

  • Poriya Medical Center

    Tiberias

    Jannat Mukari, SC, 972-4-6652201

    Wadi Kinany, MD

    Recruiting

Other trials in Israel

Spain1 site, 1 recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

    Paloma Gastelurrutia, SC, 0034 930 330 521, pgastelurrutia@gmail.com

    Antoni Bayes-Genis, MD

    Recruiting

Other trials in Spain

About this study

Official title: An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System

Study Design:

This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.

Read the detailed description

Two periods:

Run-In period will be a period in which patients will submit daily recordings, baseline creation

Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first.

Conditions
Heart Failure
Being tested
Hearo App
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hearo AppDevice

    No intervention - only data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Failure Events (HFEs)

    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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start11 Feb 2022
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion15 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06378632
Sponsor's protocol ID
CLN0011 DETECT-HF
Acronym
DETECT-HF
Status last verified
Mar 2025
First submitted
14 Apr 2024
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Cordio Medical at 45 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Israel, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bill Tobin ((203) 852-8900, billt@ihcresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Failure Events (HFEs) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06378632.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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