Heart FailureREMOTI-HFNCT06422832
Remote Monitoring To Identify Worsening Heart Failure The REMOTI-HF Randomized Clinical Trial
A study testing HeartLogic or TriageHF Algorithms for implantable devices in people with Heart Failure and Arrythmia, run by Unidade Local de Saúde de Coimbra, EPE.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Arrythmia
- What is being tested?
- HeartLogic or TriageHF Algorithms for implantable devices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- HeartLogic or TriageHF Algorithms for implantable devices
- Keywords
- Heart Failure, Remote Monitoring, ICD, CRT
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartLogic or TriageHF Algorithms for implantable devicesOther
Activation of the HeartLogic and TriageHF algorithms for implantable devices and correctly act according to its design
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | In this group the respective algorithm will be activated and alerts will be sent according to its design Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite Outcome
All-cause mortality, Hospital Admission for Heart Failure, Ventricular Arrhythmias and Worsening Heart Failure as defined in the secondary outcome area.
Measured: 2 years
Secondary outcomes (5)
All-cause mortality
All-cause mortality
Measured: 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
Measured: 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.
Measured: 2 eras
Ventricular Arrhythmias
Detection of any ventricular arrhythmia through hospital visit, appropriate device therapy or device detection
Measured: 2 years
Atrial Arrhytmias
Occurrence of any atrial arrhythmia prompting medical evaluation.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPE
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Goncalo Terleira Batista, Unidade Local de Saúde de Coimbra, EPE
- Investigators
- Gonçalo Batista, MD, Principal investigator, ULS Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422832
- Sponsor's protocol ID
- RHF230808
- Acronym
- REMOTI-HF
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batista GT, Antonio N, Primo MJ, Lopes V, Rocha L, Franco F, Costa M, Jordao I, Paiva P, Dias P, Parente F, Goncalves L. Design and Rationale of the REmote Monitoring to Identify worsening Heart Failure: The REMOTI-HF Randomized Clinical Trial. Int J Heart Fail. 2026 Jun 4;8(3):271-279. doi: 10.36628/ijhf.2025.0064. eCollection 2026 Jul.
PubMed 42568431
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring To Identify Worsening Heart Failure: The REMOTI-HF Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06422832
- Acronym / sponsor ID
- REMOTI-HF / RHF230808
- Conditions
- Heart Failure, Arrythmia
- Keywords
- Heart Failure, Remote Monitoring, ICD, CRT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Unidade Local de Saúde de Coimbra, EPEUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: HeartLogic or TriageHF Algorithms for implantable devicesIn this group the respective algorithm will be activated and alerts will be sent according to its design |
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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%.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartLogic or TriageHF Algorithms for implantable devicesActivation of the HeartLogic and TriageHF algorithms for implantable devices and correctly act according to its design | Other | Interventional group |
Primary outcome
Primary Composite Outcome
Time frame: 2 years
All-cause mortality, Hospital Admission for Heart Failure, Ventricular Arrhythmias and Worsening Heart Failure as defined in the secondary outcome area.
5 secondary outcomes
All-cause mortality
Time frame: 2 years
Hospital admission for Heart Failure
Time frame: 2 years
Worsening Heart failure
Time frame: 2 eras
Ventricular Arrhythmias
Time frame: 2 years
Atrial Arrhytmias
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Derived from this study: PubMed 42568431Batista GT, Antonio N, Primo MJ, Lopes V, Rocha L, Franco F, Costa M, Jordao I, Paiva P, Dias P, Parente F, Goncalves L. Design and Rationale of the REmote Monitoring to Identify worsening Heart Failure: The REMOTI-HF Randomized Clinical Trial. Int J Heart Fail. 2026 Jun 4;8(3):271-279. doi: 10.36628/ijhf.2025.0064. eCollection 2026 Jul.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonçalo Batista, MD principal investigator
ULS Coimbra
Questions about this trial
What is this clinical trial studying?
A study testing HeartLogic or TriageHF Algorithms for implantable devices in people with Heart Failure and Arrythmia, run by Unidade Local de Saúde de Coimbra, EPE.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gonçalo Batista, MD (963596295 ext. 00351, goncalo96batista@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Composite Outcome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06422832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.