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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Device: ExpHeart

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).

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ursula Morjaria, MBA; Phone Number: 0032477233270; Email: umorjaria@cardio-renal.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ExpHeart; The Information System is a cyber-securised web application and the Expert System uses a proprietary therapeutic algorithm to optimize pharmacological HF treatment.

Device: ExpHeart; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	All cause hospitalization (total number of participants hospitalized for any cause)	5 weeks
Mortality (number of all cause death)	All cause death	5 weeks
Heart failure hospitalization (number of patients hospitalized for heart failure)	Heart failure hospitalization defined as: Heart failure related visit to an emergency room; Heart failure related visit to an ambulatory heart failure care; Heart failure related hospital admissions	5 weeks
Hyperkalemia (number of participants with episode of hyperkaliemia)	Hyperkalemia >6 mmol/L (confirmed by immediate recheck on site with vein puncture by the study nurse)	5 weeks
Hypokalemia (number of participants with episode of hypokaliemia)	Hypokalemia <3.5 mmol/L (confirmed by immediate recheck on site with vein puncture by the study nurse)	5 weeks
Renal function	Number of participants with at least one episode of worsening renal function >50 %, >100 %	5 weeks
Feasibility outcome	Number of successful procedures during each study steps from puncture and sampling process to implementation of the specific action at the patient level	5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacotherapy	Number of participants with changes from baseline to 5 weeks post enrollment of doses of ACE inhibitors or ARB or ARNI or MRAs and of loop diuretics	5 weeks
Dose titration	Frequency of dose titration of ACE inhibitors or ARB or ARNI or MRAs and of loop diuretics	5 weeks
Rate of patients with optimal therapy	Rate of patients receiving optimal therapy of ACE inhibitors or ARB or ARNI or MRAs (i.e. receiving doses > 50% of guideline target doses), alive, and not hospitalized for heart failure	5 weeks
Congestion	Changes from baseline to 5 weeks post enrollment in congestion score as assessed by lung comet ultrasound	5 weeks
Changes in BNP	Changes from baseline to 5 weeks post enrollment in blood levels of BNP (pg/mL)	5 weeks
Hemoglobin	Changes from baseline to 5 weeks in blood hemoglobin concentration (g/L)	5 weeks
Hemoglobin	Changes from baseline to 5 weeks in hematocrit (%)	5 weeks
Renal function	Changes from baseline to 5 weeks in eGFR (ml/min/1.7 m2) (using the CKD EPI formula)	5 weeks
Blood potassium	Changes from baseline to 5 weeks in blood potassium (mmol/L)	5 weeks
Patient experience	Sociology survey with questionnaire on subjective experience (Optional sub-study) Changes from baseline to 5 weeks in Health-related Quality of life, measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ)	5 weeks
Exploratory pathophysiological outcomes	Correlation between changes in Hb and hematocrit with the following parameters: BNP changes from baseline (pg/mL); Lung comet changes (congestion score as assessed by lung comet ultrasound); HF-related visit to an emergency room (number of visits); HF-related visit to an ambulatory HF care unit (number of visits); HF-related hospital admissions (number of days of hospitalizations); HF-related death (number of deaths due to HF); Administration of an intravenous diuretic (dose of intravenous diuretic); Increase in dose of, or addition of a new, oral diuretic	5 weeks

Collaborators and Investigators

• Sponsor: CardioRenal
• Investigators: Principal Investigator: Alexandre Mebazaa, MD, Hôpital Lariboisière

Publications and helpful links

Helpful Links

• Official Website of CardioRenal

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2019
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 8, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: heart failure; algorithm
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR-2018-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No