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

NCT ID: NCT06422832

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-07-01

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.

Detailed Description

Patients will be randomized into two arms: one with the activation of the algorithm and the other with no active algorithm. The algorithm is programmed to alert our team upon detecting a patient at risk of worsening heart failure. When an alarm is triggered, the patient will receive a telephone call from the investigation team. Subsequently, the patient may be scheduled for a hospital visit, or ambulatory medication adjustments can be made.

For patients in whom the algorithm is deactivated, no such alarm mechanism will be in place.

Patients in both arms will undergo comparison based on relevant heart failure events, defined as follows:

• All-Cause Mortality
• Hospital Admission for Heart Failure
• Hospital Visit for Worsening Heart Failure
• Ventricular Arrhythmias
• Atrial Arrhythmias

Additionally, the study will explore the association between physical activity measured by the devices and these specified events.

In addition to evaluating patient outcomes, a correlation analysis will be conducted to examine the relationship between the absolute value provided by the algorithm and absolute NT-proBNP values. This analysis aims to assess the concordance and potential predictive value of the algorithm's output with established biomarkers, specifically NT-proBNP, in the context of heart failure progression and severity (if possible).

Conditions

Heart Failure; Arrythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Interventional group

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

Group Type: EXPERIMENTAL

HeartLogic or TriageHF Algorithms for implantable devices

Intervention Type: OTHER

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

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HeartLogic or TriageHF Algorithms for implantable devices

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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%.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unidade Local de Saúde de Coimbra, EPE

OTHER

Sponsor Role: lead

Responsible Party

Goncalo Terleira Batista

Cardiology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gonçalo Batista, MD

Role: PRINCIPAL_INVESTIGATOR

ULS Coimbra

Central Contacts

Gonçalo Batista, MD

Role: CONTACT

goncalo96batista@gmail.com

963596295 ext. 00351

Other Identifiers

RHF230808

Identifier Type: -

Identifier Source: org_study_id