Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data

Korábbi kezelés

• Has acute coronary syndrome within the last 30 days before randomization.
• Has acute inflammatory heart disease, (for instance, acute myocarditis), within 90 days prior to randomization.
• Has known current alcohol or illicit drug abuse.

Más betegség

• Has a planned revascularisation, cardiac resynchronization therapy (CRT) implantation or any valvular procedures within 3 months after randomization
• Shows significant impairment or unwillingness to use the telemonitoring equipment (for instance, dementia, impaired self-determination, lacking ability to communicate).
• Has any severe non-cardiovascular disease limiting life expectancy to less than 1 year.

Egyéb

• Is clinically unstable at the time of randomization as defined by: administration of intravenous diuretics during the last 12 hours or intravenous vasodilators or inotropes during the last 48 hours before randomization.
• Is pregnant.
• Participates currently in other telemonitoring programs/studies using smart devices

• Age of 18-75 years.
• Ability to understand and provide consent in order to participate in the study.
• Have a cognitive assessment score of > 22 as assessed by the Montreal Cognitive Assessment (MoCA), ( adults without or with mild cognitive impairment at most).
• Have a depression score as assessed by Personal Health Questionnaire-9 (PHQ-9) score < 10.
• Provide written informed consent.
• For Heart Failure patients: 1) have a diagnosis of symptomatic heart failure (class II or III according to the New York Heart Association Classification); 2) have echocardiographically determined left ventricular ejection fraction (LVEF) ≤40%; 3) have been hospitalized due to cardiovascular reasons or had urgent visit to the Emergency Department due to decompensated HF that required administration of intravenous diuretics within the last 12 months before randomization (Currently hospitalized patients can be included provided they do not fulfill exclusion criterion of being currently with in-hospital administration of IV diuretics/vasoactive/inotropic drugs).
• For patients with ventricular assist devices (VAD): have left ventricular assist device (LVAD) implanted either as destination therapy or as bridge-to-transplantation, within at least 90 days and no longer than 48 months before randomization
• for heart transplant recipients: have been discharged following heart transplantation within at least 30 days and no longer than 36 months before study randomization.