Status:
UNKNOWN
Chronic Heart Failure Therapy Optimization With CardioRenal Remote Monitoring System (HERMESHF)
Lead Sponsor:
CardioRenal
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 failur...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04050904
Start Date
August 15 2019
End Date
March 31 2020
Last Update
August 9 2019
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