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

NCT06944405 | Not Yet Recruiting DMC

• 1 other identifier: HF202311
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Heart Failure

Keywords

heart failure; smartphone detection; mechanocardiography

Outcome Measures

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.

  From enrollment to the end of treatment at 90 days

Study Arms (1)

Mechanocardiography

OTHER

Using mechanocardiography for the detection of signs of heart failure.

Device: Mechanocardiography

Interventions

Mechanocardiography DEVICE

Using mechanocardiography for the detection of signs of heart failure.

Mechanocardiography

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Precordior Ltd: lead
• Eshmoun Clinical Research Center: collaborator
• Sahloul Hospital of Sousse: collaborator

Study Sites (2)

Fattouma Bourguiba University Hospital, Emergency department

Monastir, Monastir Governorate, 5000, Tunisia

Location

Sahloul Hospital, Emergency department

Sousse, Sousse Governorate, 4054, Tunisia

Location

Related Publications (7)

• 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.

  PMID: 38505488 BACKGROUND

• 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.

  PMID: 27206819 BACKGROUND

• 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.

  PMID: 38169072 BACKGROUND

• 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.

  PMID: 36356631 BACKGROUND

• 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.

  PMID: 38573263 BACKGROUND

• 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.

  PMID: 32374344 BACKGROUND

• 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.

  PMID: 37622666 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Blaz Mrevlje, MD, PhD

CONTACT

+358 50 373 0895; blaz.mrevlje@cardiosignal.com

Juuso Blomster, MD, PhD

CONTACT

+358503100194; juuso.blomster@cardiosignal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 25, 2025
• Study Start: May 10, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)