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

Launched by PUERTA DE HIERRO UNIVERSITY HOSPITAL · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on improving the care of patients with chronic heart failure, heart transplant recipients, and those with left ventricular assist devices (LVADs). The researchers aim to develop a digital platform that continuously monitors these patients' health and gathers important information about their medical condition, lifestyle, and emotional well-being. By using this data, doctors can make better treatment decisions and hopefully reduce hospital visits and improve the overall quality of life for participants.

To participate in this study, individuals need to be between 18 and 75 years old and have specific heart-related conditions. They will receive wearable devices to track vital signs, physical activity, and other health indicators, all through a user-friendly mobile app. The study will last for 18 months, during which participants will have regular check-ins with their doctors, but their usual medical care will not be affected. Importantly, there will be two groups: one where doctors can see the data collected and another where they cannot. This will help researchers understand the impact of continuous monitoring on patient care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • 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 a planned revascularisation, cardiac resynchronization therapy (CRT) implantation or any valvular procedures within 3 months after randomization
• • Has known current alcohol or illicit drug abuse.
• • 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.
• • Is pregnant.
• • Participates currently in other telemonitoring programs/studies using smart devices