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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Study details
    Heart Failure

NCT05653726

Hospital Universitario 12 de Octubre

15 October 2025

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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