Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial

NCT06422832 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2024-05-21

No results posted yet for this study

Summary

Heart failure, characterized by high mortality and morbidity rates, frequent hospital admissions, and prolonged stays in cardiology wards, significantly impacts patients' quality of life.

The REMOTI-HF is a single-center randomized controlled trial designed to assess the impact of remote monitoring, utilizing the HeartLogic and TriageHF algorithms, in patients with heart failure with implantable cardioverter defibrillator or cardiac resynchronization therapy. The primary endpoints include mortality, hospital admissions related to heart failure, and visits for worsening heart failure.

Moreover, we will explore the full capabilities of these algorithms, by analysing the association of physical activity, measured by the devices, with the same key outcomes. Additionally, the research will explore the relationship between the absolute values provided by the algorithms and NT-proBNP values.

Conditions

Interventions

OTHER

HeartLogic or TriageHF Algorithms for implantable devices

Activation of the HeartLogic and TriageHF algorithms for implantable devices and correctly act according to its design

Sponsors & Collaborators

  • Unidade Local de Saúde de Coimbra, EPE

    lead OTHER

Principal Investigators

  • Gonçalo Batista, MD · ULS Coimbra

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-02-01
Completion
2026-07-01

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06422832 on ClinicalTrials.gov