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Not yet recruitingNCT06944405COSI-HOMEUpdated Apr 25, 2025

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

An interventional study of Mechanocardiography in Heart Failure, sponsored by Precordior Ltd. Not yet recruiting at 2 sites in Tunisia. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by Precordior Ltd · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • heart failure
  • smartphone detection
  • mechanocardiography
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 65 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Precordior Ltd is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
65 participants (estimated)

Study arms

  • Other
    Mechanocardiography

    Using mechanocardiography for the detection of signs of heart failure.

    Device: Mechanocardiography

Interventions

  • DeviceMechanocardiography

    Using mechanocardiography for the detection of signs of heart failure.

06

What researchers measure

Primary outcomes

  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.

    Time frame: From enrollment to the end of treatment at 90 days

07

Study locations

2 sites
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06944405
Lead sponsor
Precordior Ltd
Collaborators
Eshmoun Clinical Research Center, Sahloul Hospital of Sousse
Responsible party
Sponsor
First posted
Apr 25, 2025
Start date
May 10, 2025 (estimated)
Primary completion
Jan 31, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Apr 25, 2025

Study contacts

Blaz Mrevlje, MD, PhD
Contact
blaz.mrevlje@cardiosignal.com
+358 50 373 0895
Juuso Blomster, MD, PhD
Contact
juuso.blomster@cardiosignal.com
+358503100194

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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