Heart Failure AcuteTELE_HFNCT07699874
Continuous Remote ECG Monitoring to Predict 30-day Outcome After Hospital Discharge in Patients With Heart Failure : A Pilot Study Using a New Wearable Sensor
An observational study of Heart Failure Acute and Telemonitoring, run by University of Monastir at 1 site in Tunisia.
Trial summary
Heart failure (HF) is a growing global public health concern. Worldwide, the estimated prevalence of HF has increased to >64.3 million cases. Despite improvement in outcomes with medication, HF is a leading cause of hospitalization among individuals >65 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure Acute, Telemonitoring
- What is being tested?
- ECG Monitoting
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: All patients with HF decompensation who will be discharged from the emergency department of Fattouma Bourguiba University Hospital (Monastir, Tunisia) and emergency department of Sahloul University Hospital following HF decompensation.
Inclusion Criteria: (1) Patients having an HF decompensation diagnosis, patients with reduced ejection fraction<50%, (2) having a documented AF (3) have a plan for discharging with partnering home health services, (4) agree to use the wearable ECG patch for 30 days (5) with a permanent residential address (6) without significant cognitive impairment and (7) understand English language.
-
Exclusion Criteria: (1) patients having implanted pacemaker or any electrical devices; (2) having an allergy to hydrocolloid gel adhesive or skin diseases; (3) unstable vital signs, (4) being on dialysis; (5) having a documented visual, cognitive, or physical impairment that would interfere with the ability to comply with the study procedures, (6) pregnant women (7) having inability to give an informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Remote ECG Monitoring to Predict 30-day Outcome After Hospital Discharge in Patients With Heart Failure and Atrial Fibrillation: A Pilot Study Using a New Wearable Sensor
Heart failure (HF) is a growing global public health concern. Worldwide, the estimated prevalence of HF has increased to >64.3 million cases. Despite improvement in outcomes with medication, HF is a leading cause of hospitalization among individuals >65 years. Approximately 30-40% of HF patients have a history of hospitalization, and 50% are re- admitted with 1 year within their initial diagnosis of HF . In Tunisia, the current statistics (2017) show that the all-cause 1-year mortality rate among acute HF patient was 22.8%, the 1-year rate of hospitalization because of HF was 7.3%, and the 1-year incidence rates of the combined event (all-cause mortality or HF hospitalization) was 18.7%. Available literature highlighted that patient monitoring using wearable biosensors is a promising strategy to improve cardiovascular patients care and have potential to support clinical practice and improve patient outcomes .
The objective of this protocol is to evaluate the feasibility and effectiveness of continuous tele- ECG monitoring in predicting hospital readmission and other clinical relevant outcome in patients with AF discharged from the emergency department (ED) after HF decompensation using a novel device "VIVALINK ECG Patch".
- Conditions
- Heart Failure Acute, Telemonitoring
- Being tested
- ECG Monitoting
- Keywords
- heart failure, acute decompensation, telemedicine, telemonitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG MonitotingDevice
Participants will be provided with a chest-worn biosensor ECG patch (Vivalink's multi-vital wearable ECG monitor, VIVALINK California, USA) , which collects real-time continuous ECG and heart rate variability. This multi-function cardiac patch can live stream multiple parameters to a mobile device or the cloud. It is reusable, rechargeable. The related platform offers both raw vital and analysis data: (1) Raw vital data records the ECG, heart rate, respiratory rate, and acceleration with timestamps, (2) Analysis data: arrhythmia detection. Continuous monitoring will be insured for 30 days after patient discharge to identify patients potentially at risk of hospital readmission. The daily statistics include mean heart rate, mean respiratory rate, acceleration index, number of premature ventricular contractions and ventricular arrythmia and other potential arrhythmias.
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission
Hospital readmission and death after ED discharge. Factors associated with hospital readmission and death will be determined.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure AcuteStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Collaborators
- Vivalink
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699874
- Sponsor's protocol ID
- Emergency Departement
- Acronym
- TELE_HF
- Status last verified
- Jan 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Remote ECG Monitoring to Predict 30-day Outcome After Hospital Discharge in Patients With Heart Failure and Atrial Fibrillation: A Pilot Study Using a New Wearable Sensor
- ClinicalTrials.gov ID
- NCT07699874
- Acronym / sponsor ID
- TELE_HF / Emergency Departement
- Conditions
- Heart Failure Acute, Telemonitoring
- Keywords
- heart failure, acute decompensation, telemedicine, telemonitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Collaborators
- Vivalink
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jul 2026 (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 (HF) is a growing global public health concern. Worldwide, the estimated prevalence of HF has increased to >64.3 million cases. Despite improvement in outcomes with medication, HF is a leading cause of hospitalization among individuals >65 years. Approximately 30-40% of HF patients have a history of hospitalization, and 50% are re- admitted with 1 year within their initial diagnosis of HF . In Tunisia, the current statistics (2017) show that the all-cause 1-year mortality rate among acute HF patient was 22.8%, the 1-year rate of hospitalization because of HF was 7.3%, and the 1-year incidence rates of the combined event (all-cause mortality or HF hospitalization) was 18.7%. Available literature highlighted that patient monitoring using wearable biosensors is a promising strategy to improve cardiovascular patients care and have potential to support clinical practice and improve patient outcomes .
The objective of this protocol is to evaluate the feasibility and effectiveness of continuous tele- ECG monitoring in predicting hospital readmission and other clinical relevant outcome in patients with AF discharged from the emergency department (ED) after HF decompensation using a novel device "VIVALINK ECG Patch".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with HF decompensation who will be discharged from the emergency department of Fattouma Bourguiba University Hospital (Monastir, Tunisia) and emergency department of Sahloul University Hospital following HF decompensation.
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 |
|---|---|---|
| ECG MonitotingParticipants will be provided with a chest-worn biosensor ECG patch (Vivalink's multi-vital wearable ECG monitor, VIVALINK California, USA) , which collects real-time continuous ECG and heart rate variability. This multi-function cardiac patch can live stream multiple parameters to a mobile device or the cloud. It is reusable, rechargeable. The related platform offers both raw vital and analysis data: (1) Raw vital data records the ECG, heart rate, respiratory rate, and acceleration with timestamps, (2) Analysis data: arrhythmia detection. Continuous monitoring will be insured for 30 days after patient discharge to identify patients potentially at risk of hospital readmission. The daily statistics include mean heart rate, mean respiratory rate, acceleration index, number of premature ventricular contractions and ventricular arrythmia and other potential arrhythmias. | Device | – |
Primary outcome
Readmission
Time frame: 30 days
Hospital readmission and death after ED discharge. Factors associated with hospital readmission and death will be determined.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Heart Failure Acute
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Not yet recruitingPhase 3
Early Discharge With Subcutaneous Furosemide Versus Standard Care in Acute Heart Failure
Heart Failure, Acute Decompensated Heart Failure
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute and Telemonitoring, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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 Tunisia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission (time frame: 30 days). 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 13 Jul 2026.