Heart FailurePhase 4Alert-HFNCT07816458
Alert-HF: Early Detection and Intervention on Atrial Fibrillation in Heart Failure Patients
A Phase 4 study testing Implantable loop recorder and Patient-driven portable ECG monitoring in people with Heart Failure, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to learn if using heart monitoring devices can lower unplanned hospital visits in adults with heart failure (HF). It focuses on adults with heart failure who have no history of an irregular heartbeat called atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implantable loop recorder and Patient-driven portable ECG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2027to Jun 2029
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with HF and no history of documented AF on electrocardiogram (ECG) are eligible.
Who cannot join
- Patients with CIED such as an implantable cardioverter defibrillator (ICD), Cardiac Resyn-chronization Therapy Defibrillator (CRT-D), or pacemaker.
- Documented AF before inclusion
- Admission to hospices or palliative care
- Inability to communicate in Dutch or English.
- Participant is under age of 18 years old
- Participant is pregnant
- Mental disorders that, according to the treating physician, make participation unsafe
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Medisch Spectrum Twente
Enschede, 7512 KZ
Dr Schuuring, MD PhD, 0031534872000, mark.schuuring@utwente.nl
About this study
The goal of this clinical trial is to learn if using heart monitoring devices can lower unplanned hospital visits in adults with heart failure (HF). It focuses on adults with heart failure who have no history of an irregular heartbeat called atrial fibrillation (AF).
The main questions the trial aims to answer are:
Read more
Does a heart monitor placed under the skin lower unplanned hospital visits? Does a portable home device lower unplanned hospital visits?
Researchers will compare these two groups to a standard care group to see which monitoring approach works best.
Participants will:
Answer a health survey at the start of the study and after 18 months. Have a small heart monitor placed under their chest skin to watch their heart rhythm, if they are in the first group.
Use a handheld device to take weekly heart readings at home, if they are in the second group.
Follow standard care from their regular doctor without any extra devices, if they are in the third group.
- Conditions
- Heart Failure
- Being tested
- Implantable loop recorder, Patient-driven portable ECG monitoring, Usual Care
- Keywords
- Heart Failure, Implantable loop recorder (ILR), Portable ECG, Atrial fibrillation, Care consumption
- Medical subject headings
- Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable loop recorderDevice
Hospital-driven continuous monitoring with an implantable loop recorder
Patient-driven portable ECG monitoringDevice
Patient-driven portable ECG monitoring
Usual CareOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder | Active comparator | Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder (ILR) Receives: Device: Implantable loop recorder |
| Arm 2: Patient-driven portable ECG monitoring | Active comparator | Patient-driven portable ECG monitoring Receives: Device: Patient-driven portable ECG monitoring |
| Arm 3: Usual Care | Active comparator | All patients are treated according to the ESC guidelines (ESC HF 2026).6 The data flow includes peri-odic outpatient utilization. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of unplanned cardiac care utilization
Number of unplanned cardiac care utilization. Healthcare utilization will be assessed as the number of healthcare episodes occurring during the study observation period. Each unique healthcare episode will be classified to the principal setting of care (hospitalization, emergency care, daycare/day case, or outpatient clinic). Healthcare episodes involving transfer from one setting to another will be counted according to the highest level of care reached, to avoid double counting. Unplanned healthcare utilization comprises unscheduled healthcare episodes initiated because of an acute, unexpected, worsening, or urgent health problem. This includes unplanned hospitalizations, emergency-care visits, and unplanned outpatient or urgent-care visits.
Measured: 18 months
Secondary outcomes (7)
Number of planned cardiac care utilization
Planned healthcare utilization comprises healthcare episodes scheduled or arranged in advance for routine, preventive, diagnostic, therapeutic, monitoring, rehabilitation, or follow-up care. This includes planned hospitalizations, planned daycare/day-case encounters, and planned outpatient clinic visits.
Measured: 18 months
Time to first diagnosis of AF
The clinical diagnosis of AF must be supported by ECG documentation showing a single-lead recording of 30 seconds or a standard 12-lead ECG, captured via the assigned monitoring de-vice or routine clinical care.
Measured: 18 months
The number of participants diagnosed with AF
AF diagnosis will be based on ECG documentation obtained through the assigned monitoring strategy or routine clinical care
Measured: 18 months
Pharmaceutical and/or CIED implantation management changes
Derived parameters will include the initiation/dose adjustment of oral anticoagulants (OAC), initiation of new rate/rhythm control medications to treat AF, performance of electrical/pharmacological cardioversion, or referral for catheter ablation.
Measured: 18 months
Number of overall arrhythmia diagnosis
Number of overall arrhythmia diagnosis
Measured: 18 months
Quality of life Kansas City Cardiomyopathy Questionnaire
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months.
Measured: 18 months
Mortality
Mortality
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816458
- Sponsor's protocol ID
- Alert-HF
- Acronym
- Alert-HF
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Santhanakrishnan R, Wang N, Larson MG, Magnani JW, McManus DD, Lubitz SA, Ellinor PT, Cheng S, Vasan RS, Lee DS, Wang TJ, Levy D, Benjamin EJ, Ho JE. Atrial Fibrillation Begets Heart Failure and Vice Versa: Temporal Associations and Differences in Preserved Versus Reduced Ejection Fraction. Circulation. 2016 Feb 2;133(5):484-92. doi: 10.1161/CIRCULATIONAHA.115.018614. Epub 2016 Jan 8.
PubMed 26746177Bhatnagar R, Fonarow GC, Heidenreich PA, Ziaeian B. Expenditure on Heart Failure in the United States: The Medical Expenditure Panel Survey 2009-2018. JACC Heart Fail. 2022 Aug;10(8):571-580. doi: 10.1016/j.jchf.2022.05.006. Epub 2022 Jul 6.
PubMed 35902161Kober L, Adamo M, Ruwald AC, Tomasoni D, Anderson LJ, Andersson C, Brugts JJ, Chioncel O, Donal E, Ferdinandy P, Jhund PS, Leyva F, Lorusso R, Madigan M, Mullens W, Paolillo S, Ryan N, Simpson M, Thiele H, Thune JJ, Van Craenenbroeck EM, Van Laake LW, Verbakel M; ESC Guidelines Advisory Group. 2026 ESC Guidelines for the management of heart failure. Eur Heart J. 2026 Aug 28:ehag100. doi: 10.1093/eurheartj/ehag100. Online ahead of print. No abstract available.
PubMed 42661420Baez-Ferrer N, Rodriguez-Cabrera CM, Parra-Esquivel PC, Burillo-Putze G, Dominguez-Rodriguez A. Prognostic Impact of Hospital Discharge After Heart Failure Admission Without Structured Heart Failure Follow-Up. J Clin Med. 2024 Dec 13;13(24):7589. doi: 10.3390/jcm13247589.
PubMed 39768511Kwok CS, Seferovic PM, Van Spall HG, Helliwell T, Clarson L, Lawson C, Kontopantelis E, Patwala A, Duckett S, Fung E, Mallen CD, Mamas MA. Early Unplanned Readmissions After Admission to Hospital With Heart Failure. Am J Cardiol. 2019 Sep 1;124(5):736-745. doi: 10.1016/j.amjcard.2019.05.053. Epub 2019 Jun 6.
PubMed 31300202Jansen C, Otterspoor LC, van Pol PEJ, IJff GC, Sinkeler SJ, van den Heuvel M, Jansen MEP, Scholten M, van Zutphen K, Verstappen CCAG, Hermanides N, Joosen IA, Heinen S, Valk JG, Vollenbroek-Hutten MMR, Schuuring MJ, van Hout GPJ. Structuring telemonitoring in heart failure care in The Netherlands: design and operational protocol of a nationwide initiative. Eur Heart J Digit Health. 2025 Nov 5;7(2):ztaf130. doi: 10.1093/ehjdh/ztaf130. eCollection 2026 Mar.
PubMed 41624560Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.
PubMed 35150240
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alert-HF: Early Detection and Intervention on Atrial Fibrillation in Heart Failure Patients
- ClinicalTrials.gov ID
- NCT07816458
- Acronym / sponsor ID
- Alert-HF / Alert-HF
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Implantable loop recorder (ILR), Portable ECG, Atrial fibrillation, Care consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 11 Sep 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.
The goal of this clinical trial is to learn if using heart monitoring devices can lower unplanned hospital visits in adults with heart failure (HF). It focuses on adults with heart failure who have no history of an irregular heartbeat called atrial fibrillation (AF).
The main questions the trial aims to answer are:
Does a heart monitor placed under the skin lower unplanned hospital visits? Does a portable home device lower unplanned hospital visits?
Researchers will compare these two groups to a standard care group to see which monitoring approach works best.
Participants will:
Answer a health survey at the start of the study and after 18 months. Have a small heart monitor placed under their chest skin to watch their heart rhythm, if they are in the first group.
Use a handheld device to take weekly heart readings at home, if they are in the second group.
Follow standard care from their regular doctor without any extra devices, if they are in the third group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder | Active comparator | Device: Implantable loop recorderArm 1: Hospital-driven continuous monitoring with an implantable loop recorder (ILR) |
| Arm 2: Patient-driven portable ECG monitoring | Active comparator | Device: Patient-driven portable ECG monitoringPatient-driven portable ECG monitoring |
| Arm 3: Usual Care | Active comparator | Other: Usual CareAll patients are treated according to the ESC guidelines (ESC HF 2026).6 The data flow includes peri-odic outpatient utilization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with HF and no history of documented AF on electrocardiogram (ECG) are eligible.
Key exclusion criteria (7 listed)
- Patients with CIED such as an implantable cardioverter defibrillator (ICD), Cardiac Resyn-chronization Therapy Defibrillator (CRT-D), or pacemaker.
- Documented AF before inclusion
- Admission to hospices or palliative care
- Inability to communicate in Dutch or English.
- Participant is under age of 18 years old
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 |
|---|---|---|
| Implantable loop recorderHospital-driven continuous monitoring with an implantable loop recorder | Device | Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder |
| Patient-driven portable ECG monitoringPatient-driven portable ECG monitoring | Device | Arm 2: Patient-driven portable ECG monitoring |
| Usual CareUsual care | Other | Arm 3: Usual Care |
Primary outcome
Number of unplanned cardiac care utilization
Time frame: 18 months
Number of unplanned cardiac care utilization. Healthcare utilization will be assessed as the number of healthcare episodes occurring during the study observation period. Each unique healthcare episode will be classified to the principal setting of care (hospitalization, emergency care, daycare/day case, or outpatient clinic). Healthcare episodes involving transfer from one setting to another will be counted according to the highest level of care reached, to avoid double counting. Unplanned healthcare utilization comprises unscheduled healthcare episodes initiated because of an acute, unexpected, worsening, or urgent health problem. This includes unplanned hospitalizations, emergency-care visits, and unplanned outpatient or urgent-care visits.
7 secondary outcomes
Number of planned cardiac care utilization
Time frame: 18 months
Time to first diagnosis of AF
Time frame: 18 months
The number of participants diagnosed with AF
Time frame: 18 months
Pharmaceutical and/or CIED implantation management changes
Time frame: 18 months
Number of overall arrhythmia diagnosis
Time frame: 18 months
Quality of life Kansas City Cardiomyopathy Questionnaire
Time frame: 18 months
Mortality
Time frame: 18 months
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 11 Sep 2026.
- Background: PubMed 26746177Santhanakrishnan R, Wang N, Larson MG, Magnani JW, McManus DD, Lubitz SA, Ellinor PT, Cheng S, Vasan RS, Lee DS, Wang TJ, Levy D, Benjamin EJ, Ho JE. Atrial Fibrillation Begets Heart Failure and Vice Versa: Temporal Associations and Differences in Preserved Versus Reduced Ejection Fraction. Circulation. 2016 Feb 2;133(5):484-92. doi: 10.1161/CIRCULATIONAHA.115.018614. Epub 2016 Jan 8.
- Background: PubMed 35902161Bhatnagar R, Fonarow GC, Heidenreich PA, Ziaeian B. Expenditure on Heart Failure in the United States: The Medical Expenditure Panel Survey 2009-2018. JACC Heart Fail. 2022 Aug;10(8):571-580. doi: 10.1016/j.jchf.2022.05.006. Epub 2022 Jul 6.
- Background: PubMed 42661420Kober L, Adamo M, Ruwald AC, Tomasoni D, Anderson LJ, Andersson C, Brugts JJ, Chioncel O, Donal E, Ferdinandy P, Jhund PS, Leyva F, Lorusso R, Madigan M, Mullens W, Paolillo S, Ryan N, Simpson M, Thiele H, Thune JJ, Van Craenenbroeck EM, Van Laake LW, Verbakel M; ESC Guidelines Advisory Group. 2026 ESC Guidelines for the management of heart failure. Eur Heart J. 2026 Aug 28:ehag100. doi: 10.1093/eurheartj/ehag100. Online ahead of print. No abstract available.
- Background: PubMed 39768511Baez-Ferrer N, Rodriguez-Cabrera CM, Parra-Esquivel PC, Burillo-Putze G, Dominguez-Rodriguez A. Prognostic Impact of Hospital Discharge After Heart Failure Admission Without Structured Heart Failure Follow-Up. J Clin Med. 2024 Dec 13;13(24):7589. doi: 10.3390/jcm13247589.
- Background: PubMed 31300202Kwok CS, Seferovic PM, Van Spall HG, Helliwell T, Clarson L, Lawson C, Kontopantelis E, Patwala A, Duckett S, Fung E, Mallen CD, Mamas MA. Early Unplanned Readmissions After Admission to Hospital With Heart Failure. Am J Cardiol. 2019 Sep 1;124(5):736-745. doi: 10.1016/j.amjcard.2019.05.053. Epub 2019 Jun 6.
- Background: PubMed 41624560Jansen C, Otterspoor LC, van Pol PEJ, IJff GC, Sinkeler SJ, van den Heuvel M, Jansen MEP, Scholten M, van Zutphen K, Verstappen CCAG, Hermanides N, Joosen IA, Heinen S, Valk JG, Vollenbroek-Hutten MMR, Schuuring MJ, van Hout GPJ. Structuring telemonitoring in heart failure care in The Netherlands: design and operational protocol of a nationwide initiative. Eur Heart J Digit Health. 2025 Nov 5;7(2):ztaf130. doi: 10.1093/ehjdh/ztaf130. eCollection 2026 Mar.
- Background: PubMed 35150240Savarese G, Becher PM, Lund LH, Seferovic P, Rosano GMC, Coats AJS. Global burden of heart failure: a comprehensive and updated review of epidemiology. Cardiovasc Res. 2023 Jan 18;118(17):3272-3287. doi: 10.1093/cvr/cvac013.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Implantable loop recorder and Patient-driven portable ECG monitoring in people with Heart Failure, run by Medisch Spectrum Twente at 1 site in Netherlands.
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 1 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: opening soon, as of the sponsor's last update on 11 Sep 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Dr. Schuuring, MD PhD (0031534872000, mark.schuuring@utwente.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of unplanned cardiac care utilization (time frame: 18 months). 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 NCT07816458, which also lists 7 linked publications.
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 11 Sep 2026.