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Chronic Heart Failure Therapy Optimization With CardioRenal Remote Monitoring System (HERMESHF) | Clinical Trials | Clareo Health

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

NCT04050904•CardioRenal

View on ClinicalTrials.gov

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.

Detailed 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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects who understand the study procedures and agree to participate by providing informed consent.
•Male or female aged ≥18 years
•Subjects with worsening HF:
•1. Currently admitted to hospital with worsening heart failure, OR
•2. Discharged within 2 weeks from hospitalization with worsening heart failure AND
•3. HF with reduced ejection fraction (i.e. ejection fraction ≤ 35% documented within 6 months before enrolment)
•4. NT-proBNP \> 1000 pg/ml, or BNP \> 200 pg/ml. For subjects with atrial fibrillation, BNP must be \> 700 pg/ml or NT-proBNP \> 2500 pg/ml.
•5. Receiving suboptimal therapy i.e. no doses or doses \< 50% of guideline target optimal of ACE inhibitors or ARB or ARNI or MRA (as per ESC guidelines recommendations, Annex II) AND at risk of developing hyperkalaemia or worsening renal function i.e. ANY of the following:
•1. documented history of hyperkalaemia or of worsening renal function leading to ACE-I or ARB or ARNI or MRA down-titration or discontinuation,
•2. age \> 75 years,
+2 more criteria

Exclusion Criteria

•Subjects with newly diagnosed heart failure within the past 3 months.
•Subjects known to be poorly adherent to their HF medications/treatment regimen.
•Subjects who have had a non-cardiac surgical procedure or cardiac-related interventional procedure (for example but not limited to angiogram, CABG, angioplasty or pacemaker insertion) within the past 30 days.
•Subjects who have had an ACS, or MI, within the past 30 days.
•Subjects with eGFR \<30 ml/min/1.73m2 (using CKD EPI formula)
•Subjects with life expectancy less than 3 months in the opinion of the investigator

Key Dates

Start Date

August 15, 2019

Primary Completion Date

January 31, 2020

Completion Date

March 31, 2020

Last Updated

August 9, 2019

Enrollment

ESTIMATED participants

Conditions

Heart Failure

Interventions

ExpHeart

DEVICE

Contacts

Ursula Morjaria, MBA

CONTACT

0032477233270 umorjaria@cardio-renal.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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