Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT06944405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-25
First Post:
2025-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CardioSignal algorithm in guiding', 'timeFrame': 'From enrollment to the end of treatment at 90 days', 'description': "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."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'smartphone detection', 'mechanocardiography'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '38505488', 'type': 'BACKGROUND', 'citation': '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': '27206819', 'type': 'BACKGROUND', 'citation': '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': '38169072', 'type': 'BACKGROUND', 'citation': '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': '36356631', 'type': 'BACKGROUND', 'citation': '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': '38573263', 'type': 'BACKGROUND', 'citation': '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': '32374344', 'type': 'BACKGROUND', 'citation': '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': '37622666', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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)', 'detailedDescription': "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.\n\nRelevant 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'genderBased': False, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients admitted at emergency room for acute heart failure.\n* Patients discharged from emergency room after an episode of acute heart failure.\n* 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).\n* BNP \\> 200 pg/ml OR NT-ProBNP \\> 800 pg/ml\n* Patients with connected smartphone.\n\nExclusion Criteria:\n\n* Patients \\<18 years and \\>85 years.\n* Pregnant women. lactating woman.\n* Previous history of allergic asthma at an early age.\n* Patients with a history of pulmonary embolism.\n* Cardiorespiratory disorders which may be aggravated by the slight compression of the thorax. (patient with a pacemaker).\n* Known allergies for: bisoprolol, ramipril, Entresto, spironolactone, empagliflozine, dapagliflozine.\n* The participant's inability to adhere to study procedures or give informed consent."}, 'identificationModule': {'nctId': 'NCT06944405', 'acronym': 'COSI-HOME', 'briefTitle': 'Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME', 'organization': {'class': 'INDUSTRY', 'fullName': 'Precordior Ltd'}, 'officialTitle': 'Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME', 'orgStudyIdInfo': {'id': 'HF202311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Mechanocardiography', 'description': 'Using mechanocardiography for the detection of signs of heart failure.', 'interventionNames': ['Device: Mechanocardiography']}], 'interventions': [{'name': 'Mechanocardiography', 'type': 'DEVICE', 'description': 'Using mechanocardiography for the detection of signs of heart failure.', 'armGroupLabels': ['Mechanocardiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'state': 'Monastir Governorate', 'country': 'Tunisia', 'contacts': [{'name': 'Semir Pr Nouira', 'role': 'CONTACT', 'email': 'semir.nouira.urg@gmail.com'}, {'name': 'Randa Dr Dhaoui', 'role': 'CONTACT', 'email': 'drrandadhaoui@yahoo.com'}, {'name': 'Semir Nouira', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fattouma Bourguiba University Hospital, Emergency department', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}, {'zip': '4054', 'city': 'Sousse', 'state': 'Sousse Governorate', 'country': 'Tunisia', 'contacts': [{'name': 'Riadh Boukef', 'role': 'CONTACT', 'email': 'boukef.riadh@famso.u-sousse.tn'}, {'name': 'Rahma Jaballah', 'role': 'CONTACT', 'email': 'jaballah.rahma@famso.u-sousse.tn'}, {'name': 'Riadh Boukef', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sahloul Hospital, Emergency department', 'geoPoint': {'lat': 35.82539, 'lon': 10.63699}}], 'centralContacts': [{'name': 'Blaz Mrevlje, MD, PhD', 'role': 'CONTACT', 'email': 'blaz.mrevlje@cardiosignal.com', 'phone': '+358 50 373 0895'}, {'name': 'Juuso Blomster, MD, PhD', 'role': 'CONTACT', 'email': 'juuso.blomster@cardiosignal.com', 'phone': '+358503100194'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Precordior Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eshmoun Clinical Research Center', 'class': 'NETWORK'}, {'name': 'Sahloul Hospital of Sousse', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}