Clinical trial NCT06944405: Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME
Official title: Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
smartphone detection
mechanocardiography
Lead sponsor: Precordior Ltd
Sponsor class: INDUSTRY
Collaborators: name: Eshmoun Clinical Research Center
name: Sahloul Hospital of Sousse
First posted: 2025-04-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CardioSignal algorithm in guiding
timeFrame: From enrollment to the end of treatment at 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Fattouma Bourguiba University Hospital, Emergency department
city: Sousse
country: Tunisia
facility: Sahloul Hospital, Emergency department
Study officials:
References:
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