Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)
NCT ID: NCT05653726
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
390 participants
INTERVENTIONAL
2023-11-29
2025-12-31
Brief Summary
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* 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Telemonitoring group
Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram.
Telemonitoring follow-up using medical devices and telematic consultations
Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months
Control gropu
Usual care follow-up group
No interventions assigned to this group
Interventions
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Telemonitoring follow-up using medical devices and telematic consultations
Home telemonitoring of blood pressure, heart rate and peripheral oxygen saturation on a daily basis during 12 months
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Consorcio Centro de Investigación Biomédica en Red (CIBER)
OTHER_GOV
Fundacion Investigacion Biomedica Hospital 12 de Octubre
UNKNOWN
Hospital Universitario Puerta de Hierro de Majadahonda
UNKNOWN
Hospital Universitario 12 de Octubre
OTHER
Responsible Party
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Juan Carlos López-Azor
Principal Investigator, Doctor in Medicine
Locations
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Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HU12Octubre
Identifier Type: -
Identifier Source: org_study_id