Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

Instituto Cardiovascular de Buenos Aires

Status: Enrolling

Conditions: Acute Heart Failure; Heart Failure

Treatments: Device: Telemonitoring with electronic alerts; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT05972746

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Details and patient eligibility

About

This pragmatic clinical trial aims to evaluate the impact of a telemonitoring program with an electronic alert system compared to standard treatment on the perception of self-care in patients after hospitalization for decompensated HF at 3 months post-discharge. And secondarily to evaluate its impact on clinical events, NT-proBNP and efficacy and safety to facilitate the use and titration of the recommended drugs in patients with reduced ejection fraction at 90 days.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Hospitalized for acute heart failure (regardless of the level of left ventricular ejection fraction) within 24 hours of discharge, or with a history of hospitalization for acute HF within 10 days prior to randomization.
• Own a smartphone (Smartphone) with internet Ability to speak and read Spanish.
• Residence in the metropolitan area of Buenos Aires

Exclusion criteria

• Pregnancy
• Alcohol or drug abuse
• Kidney failure in hemodialysis,
• Inability to use the app (Ex: cognitive impairment, lack of social support, lack of ability to communicate)
• Active cancer
• Life expectancy less than 1 year
• Candidates for care home or institutional end of life
• Severe psychiatric illness
• Planned cardiac surgery
• Patient unable or unwilling to give informed consent to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups, including a placebo group

Telemonitoring program with electronic alerts + Standard of care

Experimental group

Treatment:

Other: Standard of care

Device: Telemonitoring with electronic alerts

Standard of care

Placebo Comparator group

Treatment:

Other: Standard of care