An interventional study of ExpHeart in Heart Failure, sponsored by CardioRenal. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by CardioRenal · Not applicable, Interventional, and Diagnostic
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.
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.
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).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →CardioRenal is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects with worsening HF:
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:
Exclusion Criteria:
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.
Hospitalization
All cause hospitalization (total number of participants hospitalized for any cause)
Time frame: 5 weeks
Mortality (number of all cause death)
All cause death
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 5 weeks
Renal function
Number of participants with at least one episode of worsening renal function \>50 %, \>100 %
Time frame: 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
Time frame: 5 weeks
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
Time frame: 5 weeks
Dose titration
Frequency of dose titration of ACE inhibitors or ARB or ARNI or MRAs and of loop diuretics
Time frame: 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
Time frame: 5 weeks
Congestion
Changes from baseline to 5 weeks post enrollment in congestion score as assessed by lung comet ultrasound
Time frame: 5 weeks
Changes in BNP
Changes from baseline to 5 weeks post enrollment in blood levels of BNP (pg/mL)
Time frame: 5 weeks
Hemoglobin
Changes from baseline to 5 weeks in blood hemoglobin concentration (g/L)
Time frame: 5 weeks
Hemoglobin
Changes from baseline to 5 weeks in hematocrit (%)
Time frame: 5 weeks
Renal function
Changes from baseline to 5 weeks in eGFR (ml/min/1.7 m2) (using the CKD EPI formula)
Time frame: 5 weeks
Blood potassium
Changes from baseline to 5 weeks in blood potassium (mmol/L)
Time frame: 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)
Time frame: 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
Time frame: 5 weeks
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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