Heart Failure Clinical Trial
— HERMeSOfficial title:
Heart Failure Events Reduction With Remote Monitoring and eHealth Support Investigator Initiated Trial
Verified date | October 2022 |
Source | Hospital Universitari de Bellvitge |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of the study is to evaluate the efficacy of a telemedicine-based follow-up strategy compared with usual care in the management of patients with chronic heart failure (HF) at high risk of clinical events.
Status | Completed |
Enrollment | 510 |
Est. completion date | October 25, 2022 |
Est. primary completion date | October 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years old. - Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study or in the process of discharge planning. - Heart Failure diagnosis according to European Society of Cardiology (ESC) criteria. - Written informed consent must be obtained before any assessment is performed. - Patients receiving oral standard medication for chronic heart failure (CHF). - All patients will be eligible regardless the level of left ventricular ejection fraction (LVEF). Exclusion Criteria: - Age<18 years old. - Participation in another clinical trial. - Moderate or severe cognitive impairment without a competent caregiver. - Lack of social support. - Institutionalized patients. - Life expectancy less than 1 year (excluding HF). - Candidates for home-based or institutional end-of-life care. - Serious psychiatric illness. - Planned cardiac surgery. - Planned Heart transplantation or left ventricular assist device (LVAD) implant. - Patients in hemodialysis program. - Death before hospital discharge. - The patient is unable or unwilling to give the informed consent to participate. - The patient is considered not to be an adequate candidate for this study according to the decision of the local investigator. - Unstable patients with signs of fluid overload or low cardiac output. |
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital Bellvitge | L'Hospitalet de Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitari de Bellvitge | Institut d'Investigació Biomèdica de Bellvitge |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of cardiovascular death or non-fatal heart failure events. | Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (<24 hours) or requiring unplanned hospital admission (>24 hours) or complicating the course of a non-cardiovascular admission. | Six months after inclusion of the patient | |
Secondary | Readmission (all-cause, HF and cardiovascular) rate and total number. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | |
Secondary | Days in hospital (all-cause, HF and cardiovascular). | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | |
Secondary | Rate of emergency visits. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | |
Secondary | Rate of non-fatal HF events. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | |
Secondary | Mortality for any cause and cardiovascular mortality. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | |
Secondary | Improvement of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale). | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | |
Secondary | Improvement of quality of life using a validated questionnaire (EUROQOL - 5D). | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. | |
Secondary | Patient satisfaction using a Likert-type scale. | Comparison of both strategies at the end of follow-up. | Six months after inclusion of the patient. |
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