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

NCT04050904 | Unknown

• 1 other identifier: CR-2018-001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure

Keywords

heart failure; algorithm

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (11)

• Pharmacotherapy

  5 weeks

• Dose titration

  5 weeks

• Rate of patients with optimal therapy

  5 weeks

Study Arms (1)

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.

Device: ExpHeart

Interventions

ExpHeart DEVICE

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.

ExpHeart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CardioRenal: lead

Related Links

• Official Website of CardioRenal

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Alexandre Mebazaa, MD

  Hôpital Lariboisière

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ursula Morjaria, MBA

CONTACT

0032477233270; umorjaria@cardio-renal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective single-arm open pilot study

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: August 9, 2019
• Study Start: August 15, 2019
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share