Heart FailureHERMESHFNCT04050904
Chronic Heart Failure Therapy Optimization With CardioRenal Remote Monitoring System (HERMESHF)
A study testing ExpHeart in people with Heart Failure, run by CardioRenal.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- ExpHeart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who understand the study procedures and agree to participate by providing informed consent.
- Male or female aged ≥18 years
- Subjects with worsening HF:
- Currently admitted to hospital with worsening heart failure, OR
- Discharged within 2 weeks from hospitalization with worsening heart failure AND
- HF with reduced ejection fraction (i.e. ejection fraction ≤ 35% documented within 6 months before enrolment)
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- 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.
- 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:
- documented history of hyperkalaemia or of worsening renal function leading to ACE-I or ARB or ARNI or MRA down-titration or discontinuation,
- age > 75 years,
- eGFR < 50 ml/min/1.73 m2 anytime during hospitalization (using the CKD EPI formula),
- diabetes.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- 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.
- 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).
- Conditions
- Heart Failure
- Being tested
- ExpHeart
- Keywords
- heart failure, algorithm
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExpHeartDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ExpHeart | Experimental | The Information System is a cyber-securised web application and the Expert System uses a proprietary therapeutic algorithm to optimize pharmacological HF treatment. Receives: Device: ExpHeart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization
All cause hospitalization (total number of participants hospitalized for any cause)
Measured: 5 weeks
Mortality (number of all cause death)
All cause death
Measured: 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
Measured: 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)
Measured: 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)
Measured: 5 weeks
Renal function
Number of participants with at least one episode of worsening renal function >50 %, >100 %
Measured: 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
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start15 Aug 2019 (estimated)
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single-arm open pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioRenal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Mebazaa, MD, Principal investigator, Hopital Lariboisière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050904
- Sponsor's protocol ID
- CR-2018-001
- Acronym
- HERMESHF
- Status last verified
- Aug 2019
- First submitted
- 17 May 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Heart Failure Therapy Optimization With CardioRenal Remote Monitoring System (HERMESHF)
- ClinicalTrials.gov ID
- NCT04050904
- Acronym / sponsor ID
- HERMESHF / CR-2018-001
- Conditions
- Heart Failure
- Keywords
- heart failure, algorithm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CardioRenalIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (estimated)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-arm open pilot study
| Arm | Type | Receives |
|---|---|---|
| ExpHeart | Experimental | Device: ExpHeartThe Information System is a cyber-securised web application and the Expert System uses a proprietary therapeutic algorithm to optimize pharmacological HF treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects who understand the study procedures and agree to participate by providing informed consent.
- Male or female aged ≥18 years
- Subjects with worsening HF:
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExpHeartExpHeart 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. | Device | ExpHeart |
Primary outcome
Hospitalization
Time frame: 5 weeks
All cause hospitalization (total number of participants hospitalized for any cause)
Mortality (number of all cause death)
Time frame: 5 weeks
All cause death
Heart failure hospitalization (number of patients hospitalized for heart failure)
Time frame: 5 weeks
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
Hyperkalemia (number of participants with episode of hyperkaliemia)
Time frame: 5 weeks
Hyperkalemia >6 mmol/L (confirmed by immediate recheck on site with vein puncture by the study nurse)
Hypokalemia (number of participants with episode of hypokaliemia)
Time frame: 5 weeks
Hypokalemia <3.5 mmol/L (confirmed by immediate recheck on site with vein puncture by the study nurse)
Renal function
Time frame: 5 weeks
Number of participants with at least one episode of worsening renal function >50 %, >100 %
Feasibility outcome
Time frame: 5 weeks
Number of successful procedures during each study steps from puncture and sampling process to implementation of the specific action at the patient level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Official Website of CardioRenalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Mebazaa, MD principal investigator
Hopital Lariboisière
Questions about this trial
What is this clinical trial studying?
A study testing ExpHeart in people with Heart Failure, run by CardioRenal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ursula Morjaria, MBA (0032477233270, umorjaria@cardio-renal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization (time frame: 5 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019.