Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)
NCT05653726
Summary
The goal of this clinical trial is to know if telemonitoring and telematic follow-up reduces the healthcare resources utilization, healthcare costs and non-healthcare costs of patients with high-risk heart failure. The main questions it aims to answer are: * Does telematic follow-up reduce de use of healthcare resource utilization of patients with heart failure? * Is telematic follow-up cost-efficient in terms of reducing direct healthcare costs in heart failure patients? * Is telematic follow-up cost-efficient in terms of reducing non-healthcare costs in heart failure patients? Participants will be randomized to usual care (control group) or telematic care (interventional group). Patients randomized to the interventional group will be included in a protocol of daily automatic telemonitoring of arterial pressure, peripheral oximetry, heart rate and weight, and telematic consultations lead by a heart failure clinical specialized team. Researchers will compare the healthcare resource utilization, healthcare and non-healthcare costs of patients randomized to control vs. interventional group.
Eligibility
Inclusion Criteria: * Diagnosis of HF according to the 2021 guidelines of the European Society of Cardiology criteria for ≥3 months. * Admitted for decompensation of chronic HF. * Admitted for HF decompensation ≥30 days and ≤6 months. * HF decompensation in ≥30 days and ≤6 months but discharged directly from the emergency department or managed on an outpatient basis, but requiring intravenous diuretic administration in an ambulatory basis, or \>50% increase in loop diuretic dose. * With previous optimized prognostic medical treatment. * Under treatment with loop diuretic drugs. * New York Heart Association functional class II, III or IV. Exclusion Criteria: * Inclusion in other intervention studies. * Hemodynamic instability. * Acute myocardial infarction, acute pulmonary thromboembolism or stroke in the previous 40 days. * Uncontrolled arrhythmias * On waiting list for transplantation (any organ) or other cardiac surgery. * Advanced mechanical circulatory support. * Chronic renal disease on hemodialysis. * Life expectancy less than 1 year. * Moderate-severe cognitive impairment. * Manifest inability to use a technological system. * Institutionalized. * Limiting psychiatric pathology.
Conditions2
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NCT05653726