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

NCT06422832 | Not Yet Recruiting DMC

• 1 other identifier: RHF230808
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief 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

Heart Failure; Arrythmia

Keywords

Heart Failure; Remote Monitoring; ICD; CRT

Outcome Measures

Primary Outcomes (1)

• Primary Composite Outcome

  All-cause mortality, Hospital Admission for Heart Failure, Ventricular Arrhythmias and Worsening Heart Failure as defined in the secondary outcome area.

  2 years

Secondary Outcomes (5)

• All-cause mortality

  2 years

• Hospital admission for Heart Failure

  2 years

• Worsening Heart failure

  2 eras

• Ventricular Arrhythmias

  2 years

• Atrial Arrhytmias

  2 years

Study Arms (2)

Interventional group

EXPERIMENTAL

In this group the respective algorithm will be activated and alerts will be sent according to its design

Other: HeartLogic or TriageHF Algorithms for implantable devices

Control Group

NO INTERVENTION

The algorithm will not be activated and follow-up will continue as if the patient was not included in the study.

Interventions

HeartLogic or TriageHF Algorithms for implantable devices OTHER

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

Interventional group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Possession of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device that is compatible with the HeartLogic or TriageHF algorithms.
• Left ventricular ejection fraction at the time of device implantation must be equal to or less than 35%.

You may not qualify if:

• Younger than 18 years old or older than 85 years old.
• Unable to be contacted when out of the hospital.
• Presence of severe cognitive impairment.
• Currently on the heart transplant waiting list

Sponsors & Collaborators

• Unidade Local de Saúde de Coimbra, EPE: lead

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gonçalo Batista, MD

  ULS Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonçalo Batista, MD

CONTACT

963596295; goncalo96batista@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will not know whether the algorithms was activated or not at the beginning of the study. However, if a contact with the patient is made due to the algorithm, the patient will then understand they are not on the control group. The person responsible for contacts will also know if an individual patient is on the control or intervention group.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Resident

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: July 1, 2024
• Primary Completion: February 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share