Telemonitoring Program in the Vulnerable Phase After Hospitalization for Heart Failure

NCT ID: NCT05972746

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-07
• Study Completion Date: 2023-11-07

Brief Summary

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.

Conditions

Heart Failure; Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telemonitoring program with electronic alerts + Standard of care

Group Type: EXPERIMENTAL

Telemonitoring with electronic alerts

Intervention Type: DEVICE

Patients assigned to this group will receive standard care plus a telemonitoring program.

Standard of care

Intervention Type: OTHER

Standard of care

Standard of care

Group Type: PLACEBO_COMPARATOR

Standard of care

Intervention Type: OTHER

Standard of care

Interventions

Telemonitoring with electronic alerts

Patients assigned to this group will receive standard care plus a telemonitoring program.

Intervention Type: DEVICE

Standard of care

Standard of care

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Cardiovascular de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

Lucrecia Maria Burgos

Unit coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto Cardiovascular de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Site Status: RECRUITING

Countries

Argentina

Facility Contacts

Lucrecia Maria Burgos

Role: primary

lburgos@icba.com.ar

541141057500

Other Identifiers

0

Identifier Type: -

Identifier Source: org_study_id