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Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)

RECRUITINGN/ASponsored by Hospital Universitario 12 de Octubre
Actively Recruiting
PhaseN/A
SponsorHospital Universitario 12 de Octubre
Started2023-11-29
Est. completion2025-06-15
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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

Heart DiseaseHeart Failure

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