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Heart FailureCOSI-HOMENCT06944405

Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME

A study testing Mechanocardiography in people with Heart Failure, run by Precordior Ltd at 2 sites in Tunisia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

CardioSignal technology (mechanocardiography) could enable home follow-up after admission for acute heart failure, thus improving guidline-directed medical therapies for heart failure dose escalation while reducing the logistical constraints and stress associated with frequent hospital visits. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Heart Failure
What is being tested?
Mechanocardiography
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesTunisia
Study dates
10 May 2025to 31 Jan 2026
Phase
Interventional
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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients admitted at emergency room for acute heart failure.
  • Patients discharged from emergency room after an episode of acute heart failure.
  • Either LVEF>40% or ≤40%, either known or assessed during the index hospitalization (however at least 1/3 of patients are required from each category).
  • BNP > 200 pg/ml OR NT-ProBNP > 800 pg/ml
  • Patients with connected smartphone.

Who cannot join

  • Patients <18 years and >85 years.
  • Pregnant women. lactating woman.
  • Previous history of allergic asthma at an early age.
  • Patients with a history of pulmonary embolism.
  • Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax. (patient with a pacemaker).
  • Known allergies for: bisoprolol, ramipril, Entresto, spironolactone, empagliflozine, dapagliflozine.
  • The participant's inability to adhere to study procedures or give informed consent.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Blaz Mrevlje, MD, PhD contact

+358 50 373 0895

blaz.mrevlje@cardiosignal.com

Juuso Blomster, MD, PhD contact

+358503100194

juuso.blomster@cardiosignal.com

Tunisia2 sites

  • Fattouma Bourguiba University Hospital, Emergency department

    Monastir, Monastir Governorate, 5000

    Semir Pr Nouira, semir.nouira.urg@gmail.com

    Randa Dr Dhaoui, drrandadhaoui@yahoo.com

  • Sahloul Hospital, Emergency department

    Sousse, Sousse Governorate, 4054

    Riadh Boukef, boukef.riadh@famso.u-sousse.tn

    Rahma Jaballah, jaballah.rahma@famso.u-sousse.tn

Other trials in Tunisia

About this study

CardioSignal technology (mechanocardiography) could enable home follow-up after admission for acute heart failure, thus improving guidline-directed medical therapies for heart failure dose escalation while reducing the logistical constraints and stress associated with frequent hospital visits. The intended purpose is to detect signs of HF in adults (aged 18 years or older and < 85 years)

Read the detailed description

CardioSignal is a smartphone-based innovation using the smartphone's built-in motion sensors (accelerometer and gyroscope) for measuring heart mechanical motion (seismocardiography and gyrocardiography) when placing the phone on the chest for one minute. Innovation also includes cloud-based data analysis for heart motion signals. CardioSignal is a class IIa medical device (software as a medical device) for detecting atrial fibrillation (Afib) and measuring heart rate and soon detecting heart failure. CardioSignal provides accurate and actionable insights of heart health without the need for additional hardware for everyone and everywhere using their smartphone.

Relevant disease areas include atrial fibrillation, heart failure, and related conditions such as stroke and transient ischemic attack (TIA). The innovation supports long-term monitoring and prevention efforts for high-risk populations, including patients with hypertension, diabetes, sleep apnea, cancer, and those with a history of cardiovascular disease as well as patients discharged after a surgical operation.

The primary user groups are patients at home and healthcare providers at point-of-care. CardioSignal empowers patients to self-monitor heart health easily and affordably, enabling proactive care and improved outcomes across diverse populations, including elderly patients, chronic disease sufferers, and those awaiting specialist care or surgical procedures.

Conditions
Heart Failure
Being tested
Mechanocardiography
Keywords
heart failure, smartphone detection, mechanocardiography
Medical subject headings
Heart Failure

What participants receive

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

  • MechanocardiographyDevice

    Using mechanocardiography for the detection of signs of heart failure.

Study groups in NCT06944405
Study groupRoleWhat they receive
MechanocardiographyOtherUsing mechanocardiography for the detection of signs of heart failure.
Receives: Device: Mechanocardiography

What is being measured

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

  1. CardioSignal algorithm in guiding

    STRONG-HF study has shown that intensified up-titration of guideline-directed medical therapy in patients with heart failure significantly lowers mortality, the number of re-hospitalizations and healthcare costs. However, the logistics of patients' follow-up makes it difficult to implement it in every day practice in reality (transportation, involvment of relatives, access to echocardiography and lab tests). CardioSignal solution (medical software application installed on a smartphone using phone sensors - mechanocardiography - for the detection of signs of heart failure) could make it easier to implement providing a reliable, simple and cheap solution, which can be used at the point-of-care for heart failure therapy optimization.

    Measured: From enrollment to the end of treatment at 90 days

Timeline

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

  1. First posted25 Apr 2025
  2. Study start10 May 2025 (estimated)
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06944405
Sponsor's protocol ID
HF202311
Acronym
COSI-HOME
Status last verified
Apr 2025
First submitted
15 Apr 2025
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tromp J, Sarra C, Nidhal B, Mejdi BM, Zouari F, Hummel Y, Mzoughi K, Kraiem S, Fehri W, Gamra H, Lam CSP, Mebazaa A, Addad F. Nurse-led home-based detection of cardiac dysfunction by ultrasound: results of the CUMIN pilot study. Eur Heart J Digit Health. 2023 Dec 12;5(2):163-169. doi: 10.1093/ehjdh/ztad079. eCollection 2024 Mar.

    PubMed 38505488

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

    PubMed 27206819

  • Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2024 Jan;26(1):5-17. doi: 10.1002/ejhf.3024. Epub 2024 Jan 3.

    PubMed 38169072

  • Mebazaa A, Davison B, Chioncel O, Cohen-Solal A, Diaz R, Filippatos G, Metra M, Ponikowski P, Sliwa K, Voors AA, Edwards C, Novosadova M, Takagi K, Damasceno A, Saidu H, Gayat E, Pang PS, Celutkiene J, Cotter G. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial. Lancet. 2022 Dec 3;400(10367):1938-1952. doi: 10.1016/S0140-6736(22)02076-1. Epub 2022 Nov 7.

    PubMed 36356631

  • Haddad F, Saraste A, Santalahti KM, Pankaala M, Kaisti M, Kandolin R, Simonen P, Nammas W, Jafarian Dehkordi K, Koivisto T, Knuuti J, Mahaffey KW, Blomster JI. Smartphone-Based Recognition of Heart Failure by Means of Microelectromechanical Sensors. JACC Heart Fail. 2024 Jun;12(6):1030-1040. doi: 10.1016/j.jchf.2024.01.022. Epub 2024 Apr 3.

    PubMed 38573263

  • Bassi NS, Ziaeian B, Yancy CW, Fonarow GC. Association of Optimal Implementation of Sodium-Glucose Cotransporter 2 Inhibitor Therapy With Outcome for Patients With Heart Failure. JAMA Cardiol. 2020 Aug 1;5(8):948-951. doi: 10.1001/jamacardio.2020.0898.

    PubMed 32374344

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Skibelund AK; ESC Scientific Document Group. 2023 Focused Update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2023 Oct 1;44(37):3627-3639. doi: 10.1093/eurheartj/ehad195. No abstract available.

    PubMed 37622666

Questions about this trial

What is this clinical trial studying?

A study testing Mechanocardiography in people with Heart Failure, run by Precordior Ltd at 2 sites in Tunisia.

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. 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: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Tunisia. 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 Blaz Mrevlje, MD, PhD (+358 50 373 0895, blaz.mrevlje@cardiosignal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CardioSignal algorithm in guiding (time frame: From enrollment to the end of treatment at 90 days). 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 NCT06944405, which also lists 7 linked publications.

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 25 Apr 2025.

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