Heart failure impaired cardiac pump function
Conditions
Interventions
The study population comprises chronic heart failure patients in NYHA class II or III with at least one episode of worsening heart failure requiring escalation of background diuretic therapy in the am
35%, and/or moderate to severe mitral regurgitation, and/or pulmonary hypertension (systolic pulmonary artery pressure = 35 mmHg) AND who carry a HeartLogic compatible ICD or CRT-D.
Intervention (if a
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria:Written informed consent obtainedAge of or above 18 yearsDiagnosis of chronic heart failure (according to the definition in the ESC heart failure guideline 2021) at least 3 months prior to enrolmentNYHA functional class II or IIIAt least one episode of worsening heart failure requiring escalation of background diuretic therapy in the ambulant setting and/or treatment with intravenous diuretics and/or inotropes in the 12 months before enrollment OR an increased risk of developing worsening heart failure based on one or more of the following echocardiographic criteria (from an exam performed within the past 6 months): left ventricular ejection fraction < 35%, and/ormoderate to severe mitral regurgitation, and/or pulmonary hypertension (systolic pulmonary artery pressure = 35 mmHg)Carrier of a HeartLogic compatible CIED
Exclusion criteria
Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:a major cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke) within 3 months prior to enrolmentlack of unwillingness to comply with CIED remote monitoringa CRT device implanted < 3 months prior to enrolmenta glomerular filtration rate < 25 ml/min, refractory to diuretic therapy or on chronic renal dialysiscomplex congenital heart diseasemechanical circulatory supportactive malignancy with estimated life expectancy of < 1 year and/ or comfort-focused carescheduled for or likely to undergo heart-transplantation or ventricular assist device implantation within 6 months of enrolmentIn line with good clinical practice, a patient cannot participate in any other intervention study during the study period. Additionally, a patient cannot participate in any other active telemonitoring program at inclusion, randomization or during follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The rate of heart failure hospitalizations and the health-related quality of life (primary co-endpoints) in patients randomized to HeartLogic based heart failure management will be compared to the rate of heart failure hospitalizations and the health-related quality of life in patients randomized to standard care. These co-primary objectives are considered equally important. The definition of a heart failure hospitalization is an unplanned hospital admission due to worsening heart failure, requiring treatment with intravenous diuretics and/or inotropes. Health-related quality of life will be assessed with the use of the KCCQ overall summary score | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: To compare all-cause mortality, cardiovascular mortality, composite of mortality and cumulative heart failure hospitalizations and intravenous diuretic visits, days admitted in the hospital for heart failure, days admitted in the hospital for any cause, days alive outside the hospital, rate of all cause hospitalizations, total rate of planned hospital contacts (out- patient clinic and admissions), total rate of unplanned hospital contacts (out-patient clinic, emergency ward and admissions), time to first clinically manifest worsening heart failure episode, cumulative change in heart failure medications (guideline dictated therapy), frequency of HeartLogic alerts, positive and negative predictive value of HeartLogic alerts, sensitivity and specificity of HeartLogic alerts, patient and clinic compliance, patient anxiety (with the use of the HADS anxiety questionnaire), generic health-related quality of life and health utility (with the use of the EQ-5D-5L questionnaire), cost- effectiveness and environmental impact (carbon footprint) between HeartLogic based versus standard of care heart failure management. | — |
Countries
Netherlands
Contacts
Public ContactS.L.M.A. Beeres
Leids Universitair Medisch Centrum
Outcome results
None listed