Clinical trial NCT04050904: Chronic Heart Failure Therapy Optimization With CardioRenal Remote Monitoring System (HERMESHF)
Official title: Chronic Heart Failure Therapy Optimization With CardioRenal Remote Monitoring System (HERMESHF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
algorithm
Lead sponsor: CardioRenal
Sponsor class: INDUSTRY
First posted: 2019-08-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective single-arm open pilot study
Primary purpose: DIAGNOSTIC

Brief 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 criteria: 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,
     3. eGFR \< 50 ml/min/1.73 m2 anytime during hospitalization (using the CKD EPI formula),
     4. diabetes.

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

Primary outcomes:
measure: Hospitalization
timeFrame: 5 weeks
measure: Mortality (number of all cause death)
timeFrame: 5 weeks
measure: Heart failure hospitalization (number of patients hospitalized for heart failure)
timeFrame: 5 weeks
measure: Hyperkalemia (number of participants with episode of hyperkaliemia)
timeFrame: 5 weeks
measure: Hypokalemia (number of participants with episode of hypokaliemia)
timeFrame: 5 weeks
measure: Renal function
timeFrame: 5 weeks
measure: Feasibility outcome
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
measure: Pharmacotherapy
timeFrame: 5 weeks
measure: Dose titration
timeFrame: 5 weeks
measure: Rate of patients with optimal therapy
timeFrame: 5 weeks
measure: Congestion
timeFrame: 5 weeks
measure: Changes in BNP
timeFrame: 5 weeks
measure: Hemoglobin
timeFrame: 5 weeks
measure: Hemoglobin
timeFrame: 5 weeks
measure: Renal function
timeFrame: 5 weeks
measure: Blood potassium
timeFrame: 5 weeks
measure: Patient experience
timeFrame: 5 weeks
measure: Exploratory pathophysiological outcomes
timeFrame: 5 weeks
Locations:
Study officials:
affiliation: Hôpital Lariboisière
name: Alexandre Mebazaa, MD
role: PRINCIPAL_INVESTIGATOR
References: