beta
Trial Radar AI
Clinical Trial NCT06944405 (COSI-HOME) for Heart Failure is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

Implementation for Heart Failure Therapies Post-discharge Followed by CardiOSIgnal at HOME (COSI-HOME) 65 At-Home Dose Escalation

Not yet recruiting
Clinical Trial NCT06944405 (COSI-HOME) is an interventional study for Heart Failure and is currently not yet recruiting. Enrollment is planned to begin on 10 May 2025 and continue until the study accrues 65 participants. Led by Precordior Ltd, this study is expected to complete by 31 January 2026. The latest data from ClinicalTrials.gov was last updated on 25 April 2025.
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 ...Show More
Official Title

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

Conditions
Heart Failure
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • COSI-HOME
  • HF202311
NCT ID Number
NCT06944405
Start Date (Actual)
2025-05-10
Last Update Posted
2025-04-25
Completion Date (Estimated)
2026-01-31
Enrollment (Estimated)
65
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
heart failure
smartphone detection
mechanocardiography
Primary Purpose
Diagnostic
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherMechanocardiography
Using mechanocardiography for the detection of signs of heart failure.
Mechanocardiography
Using mechanocardiography for the detection of signs of heart failure.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Precordior Ltd logoPrecordior Ltd
  • Eshmoun Clinical Research Center logoEshmoun Clinical Research Center
  • Sahloul Hospital of Sousse logoSahloul Hospital of Sousse
Study Central Contact
Contact: Blaz Mrevlje, MD, PhD, +358 50 373 0895, [email protected]
Contact: Juuso Blomster, MD, PhD, +358503100194, [email protected]
2 Study Locations in 1 Countries

Monastir Governorate

Fattouma Bourguiba University Hospital, Emergency department, Monastir, Monastir Governorate, 5000, Tunisia
Semir Pr Nouira, Contact, [email protected]
Randa Dr Dhaoui, Contact, [email protected]
Semir Nouira, Principal Investigator

Sousse Governorate

Sahloul Hospital, Emergency department, Sousse, Sousse Governorate, 4054, Tunisia
Riadh Boukef, Contact, [email protected]
Rahma Jaballah, Contact, [email protected]
Riadh Boukef, Principal Investigator