Heart Failure
Conditions
Keywords
heart failure, smartphone detection, mechanocardiography
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)
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.
Interventions
DEVICEMechanocardiography
Using mechanocardiography for the detection of signs of heart failure.
Sponsors
Eshmoun Clinical Research Center
Sahloul Hospital of Sousse
Precordior Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CardioSignal algorithm in guiding | From enrollment to the end of treatment at 90 days | 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. |
Countries
Tunisia
Contacts
Primary ContactBlaz Mrevlje, MD, PhD
Backup ContactJuuso Blomster, MD, PhD
Outcome results
None listed