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

Heart Failure Clinical Trial

— REMOTI-HF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422832
• Other study ID #: RHF230808
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Centro Hospitalar e Universitário de Coimbra, E.P.E.
• Contact: Gonçalo Batista, MD
• Phone: 963596295
• Email: goncalo96batista[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: July 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrythmia
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar e Universitário de Coimbra, E.P.E.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality	All-cause mortality	2 years
Secondary	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
Secondary	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
Secondary	Ventricular Arrhythmias	Detection of any ventricular arrhythmia through hospital visit, appropriate device therapy or device detection	2 years
Secondary	Atrial Arrhytmias	Occurrence of any atrial arrhythmia prompting medical evaluation.	2 years