Chronic Heart Failure Therapy Optimization With CardioRenal Remote Monitoring System (HERMESHF) — HERMESHF  

Heart Failure Clinical Trial

Official title: Chronic Heart Failure Therapy Optimization With CardioRenal Remote Monitoring System (HERMESHF)

Status Not yet recruiting

Clinical Trial Summary

This clinical study evaluates short-term feasibility and safety of CardioRenal ExpHeart in patients with worsening heart failure with reduced ejection fraction to optimize pharmacological heart failure treatment.

Clinical Trial Description

The study will take place as follows :

The remote monitoring of the biomarkers (5 days a week, between 7am - 12 midday). The home-based monitoring of congestion by Hb and Hte, eGFR using the CKD EPI formula (creatinine) and potassium variables will be measured with point of care devices, after minimally invasive blood sampling operated by the healthcare professional who will manually enter the data in the Information System.

2. ExpHeart is composed of an Information System (web application) and an algorithm, the Expert System, embedded on the information system. The Information System is a cyber-securised web application and the Expert System uses a proprietary therapeutic algorithm to optimize pharmacological HF treatment. The Expert System is based on the analysis of a continuously updated clinical database integrating the patient's electronic medical record (managed by the Information System). The Expert System will generate prescription recommendations directed to the treating investigator through the Information System. The Expert System recommendations are based on ESC clinical guidelines (Annex II). This evaluated solution Expheart is not CE marked yet.

3. Decision on treatment update and/or optimization will be operated by physicians and healthcare professionals who will monitor compliance with the study protocol including the smooth functioning of bilateral patientinvestigator communication, i.e. (i) receipt by the investigator of recommendations from Expheart solution, (ii) adequate action/decision of the investigator and (iii) implementation of the appropriate action at the patient level.

The Investigator will inform the patient's treating physician/General practitioner (by phone and mail) about the participation of his/her patient to the study and will inform him that any HF treatment prescription change will be performed by him/her during the study period.

Moreover, in case of any technical difficulty, assistance will be provided by a dedicated call center, serviced daily by the promotor (Monday to Friday, support@cardio-renal.com). ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT04050904
• Study type: Interventional
• Source: CardioRenal
• Contact: Ursula Morjaria, MBA
• Phone: 0032477233270
• Email: umorjaria@cardio-renal.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2019
• Completion date: March 31, 2020