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

Обзор

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)

Подробное описание

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.

Вмешательства

• Устройство Mechanocardiography
  Using mechanocardiography for the detection of signs of heart failure.

Первичные конечные точки

• CardioSignal algorithm in guiding [Срок оценки: From enrollment to the end of treatment at 90 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Tunisia · 2 центра

• Fattouma Bourguiba University Hospital, Emergency department — Monastir
• Sahloul Hospital, Emergency department — Sousse

Публикации

• 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
• 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 PMID 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 Do PMID 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 PMID 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. PMID 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. PMID 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 Up PMID 37622666

Идентификаторы

NCT: NCT06944405 · HF202311

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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