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

Madrid Health Service

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Telemonitoring follow-up using medical devices and telematic consultations

Study type: Interventional

Funder types: Other

Identifiers

NCT05653726

HU12Octubre

Details and patient eligibility

About

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.

Enrollment: 390 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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390 participants in 2 patient groups

Telemonitoring group

Experimental group

Description:

Follow-up group by telematic consultations and non-invasive daily telemonitoring of weight, blood pressure, heart rate, peripheral oxygen saturation and electrocardiogram.

Treatment:

Other: Telemonitoring follow-up using medical devices and telematic consultations

Control gropu

No Intervention group

Description:

Usual care follow-up group