Heart FailureREMOTE-HEARTNCT06173089
REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
An observational study of Heart Failure, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
Trial summary
However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Remote monitoring
- Type of treatment
- Medical device
- How many people
- 800 participants
- Where
- 1 siteHungary
- Study dates
- 30 Jan 2023to 30 Aug 2025
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: chronic heart failure with reduced ejection fraction (HFrEF) with an implanted CIED (CRT/ICD) eligible for home monitoring
Who may be able to join
- CRT-P/CRT-D patients with a feasible device for home monitoring
- ICD (VVI/VDD/DDD) patients with a feasible device for home monitoring
- SR/AFib
- Transmission performance >80% in the first 2 weeks with new device
- Informed consent
Who cannot join
- Life expectancy<1 year
- Unable to transmit data
- Patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts
- Expected non-compliance
- Pregnancy
- Known drug, alcohol abuse
- Participation in other study or HM system concept
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University - Heart and Vascular Center
Budapest, 1122
Béla Merkely, PhD,DSc, +36 20 825 8000, rektor@semmelweis.hu
Annamaria Kosztin, MD,PhD, + 36 20 666 3236, kosztin.annamaria@semmelweis.hu
About this study
However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (HFrEF). The only randomized trial, which proved the efficacy of RM on mortality was the IN-TIME trial, which used a strict protocol for detection and intervention of the heart failure events.
The primary aim of this study is to optimize the use of remote monitoring system in HFrEF patients already implanted an implantable cardiac defibrillator (ICD) or a cardiac resynchronization therapy (CRT). By creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. The primary endpoint is the non-fatal heart failure event or all-cause mortality. Secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, NYHA functional class.
Read more
By using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. Additionally, cost-effectiveness to reduce the hospitalizations will be calculated.
Due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.
- Conditions
- Heart Failure
- Being tested
- Remote monitoring
- Keywords
- remote monitoring, home monitoring, heart failure, cardiac resynchronization therapy, implantable cardioverter defibrillator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote monitoringDevice
Remote monitoring for patients with an ICD/CRT device
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of all-cause mortality, heart failure events
Measured: 12 months
Secondary outcomes (3)
cardiovascular mortality
Measured: 12 months
cardiovascular hospitalization
Measured: 12 months
unscheduled visits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start30 Jan 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University Heart and Vascular Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173089
- Sponsor's protocol ID
- 4279-1/2022
- Acronym
- REMOTE-HEART
- Status last verified
- Jan 2023
- First submitted
- 28 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REmote MOnitoring of paTiEnts witH pacEmaker or implAntable cardioverteR defibrillaTor
- ClinicalTrials.gov ID
- NCT06173089
- Acronym / sponsor ID
- REMOTE-HEART / 4279-1/2022
- Conditions
- Heart Failure
- Keywords
- remote monitoring, home monitoring, heart failure, cardiac resynchronization therapy, implantable cardioverter defibrillator
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Semmelweis University Heart and Vascular CenterUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 15 Dec 2023 (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.
However, the current guidelines recommend the use of remote monitoring (RM) in patients with cardiac implantable electronic devices (CIED) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (HFrEF). The only randomized trial, which proved the efficacy of RM on mortality was the IN-TIME trial, which used a strict protocol for detection and intervention of the heart failure events.
The primary aim of this study is to optimize the use of remote monitoring system in HFrEF patients already implanted an implantable cardiac defibrillator (ICD) or a cardiac resynchronization therapy (CRT). By creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. The primary endpoint is the non-fatal heart failure event or all-cause mortality. Secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, NYHA functional class.
By using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. Additionally, cost-effectiveness to reduce the hospitalizations will be calculated.
Due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chronic heart failure with reduced ejection fraction (HFrEF) with an implanted CIED (CRT/ICD) eligible for home monitoring
Key inclusion criteria (5 listed)
- CRT-P/CRT-D patients with a feasible device for home monitoring
- ICD (VVI/VDD/DDD) patients with a feasible device for home monitoring
- SR/AFib
- Transmission performance >80% in the first 2 weeks with new device
- Informed consent
Key exclusion criteria (7 listed)
- Life expectancy<1 year
- Unable to transmit data
- Patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts
- Expected non-compliance
- Pregnancy
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 |
|---|---|---|
| Remote monitoringRemote monitoring for patients with an ICD/CRT device | Device | – |
Primary outcome
The composite of all-cause mortality, heart failure events
Time frame: 12 months
3 secondary outcomes
cardiovascular mortality
Time frame: 12 months
cardiovascular hospitalization
Time frame: 12 months
unscheduled visits
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Individual participant dataSharing planned: Yes
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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.
Semmelweis University - Heart and Vascular Center
Budapest, Hungary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Semmelweis University Heart and Vascular Center at 1 site in Hungary.
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 5 inclusion and 7 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The composite of all-cause mortality, heart failure events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2023.