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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Arrythmia
• Intervention / Treatment: Other: HeartLogic or TriageHF Algorithms for implantable devices

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).

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gonçalo Batista, MD; Phone Number: 00351 963596295; Email: goncalo96batista@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; 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; Activation of the HeartLogic and TriageHF algorithms for implantable devices and correctly act according to its design
No Intervention: Control Group; The algorithm will not be activated and follow-up will continue as if the patient was not included in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	2 years
Hospital admission for Heart Failure	Patient admission to the hospital with symptoms or signs of congestive heart failure, needing intravenous drugs for symptom relief, ultrafiltration therapy, or other parenteral therapy	2 years
Worsening Heart failure	Unscheduled hospital visit (to the emergency department or unscheduled consultation) due to signs or symptoms of heart failure, where intravenous diuretics were administered or ambulatory diuretic dosage was increased.	2 eras
Ventricular Arrhythmias	Detection of any ventricular arrhythmia through hospital visit, appropriate device therapy or device detection	2 years
Atrial Arrhytmias	Occurrence of any atrial arrhythmia prompting medical evaluation.	2 years

Collaborators and Investigators

• Sponsor: Centro Hospitalar e Universitário de Coimbra, E.P.E.
• Investigators: Principal Investigator: Gonçalo Batista, MD, ULS Coimbra

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; ICD; Remote Monitoring; CRT
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: RHF230808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No