## Protocol Section
### Identification Module
**NCT ID:** NCT06422832

**Acronym:** REMOTI-HF

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

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

#### Organization Study ID Info
**ID:** RHF230808
#### Organization
**Class:** OTHER
**Full Name:** Centro Hospitalar e Universitário de Coimbra, E.P.E.
### Status Module
#### Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-02-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centro Hospitalar e Universitário de Coimbra, E.P.E.

#### Responsible Party

**Investigator Affiliation:** Centro Hospitalar e Universitário de Coimbra, E.P.E.

**Investigator Full Name:** Goncalo Terleira Batista

**Investigator Title:** Cardiology Resident

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Heart Failure

- Arrythmia

**Keywords:**

- Heart Failure

- Remote Monitoring

- ICD

- CRT

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** 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.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 270

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: HeartLogic or TriageHF Algorithms for implantable devices

**Label:** Interventional group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Interventional group

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

**Name:** HeartLogic or TriageHF Algorithms for implantable devices

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Primary Composite Outcome

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** All-cause mortality

**Measure:** All-cause mortality

**Time Frame:** 2 years

**Description:** 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

**Measure:** Hospital admission for Heart Failure

**Time Frame:** 2 years

**Description:** 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.

**Measure:** Worsening Heart failure

**Time Frame:** 2 eras

**Description:** Detection of any ventricular arrhythmia through hospital visit, appropriate device therapy or device detection

**Measure:** Ventricular Arrhythmias

**Time Frame:** 2 years

**Description:** Occurrence of any atrial arrhythmia prompting medical evaluation.

**Measure:** Atrial Arrhytmias

**Time Frame:** 2 years

### Eligibility Module

**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

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** goncalo96batista@gmail.com

**Name:** Gonçalo Batista, MD

**Phone:** 963596295

**Phone Ext:** 00351

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** ULS Coimbra

**Name:** Gonçalo Batista, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-31
