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Not Yet Recruiting
NCT05653726
Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)
Conditions: Heart Failure
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 390
Sponsor: Hospital Universitario 12 de Octubre
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 Criteria
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 arrhythmiasOn 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.
Source: ClinicalTrials.gov (NCT05653726). StuddyBuddy aggregates publicly available trial information.