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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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.

Dr. Schuuring, MD PhD contact

0031534872000

mark.schuuring@utwente.nl

Netherlands1 site

  • Medisch Spectrum Twente

    Enschede, 7512 KZ

    Dr Schuuring, MD PhD, 0031534872000, mark.schuuring@utwente.nl

Other trials in Netherlands

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 groups in NCT07816458
Study groupRoleWhat they receive
Arm 1: Hospital-driven continuous monitoring with an implantable loop recorderActive comparatorArm 1: Hospital-driven continuous monitoring with an implantable loop recorder (ILR)
Receives: Device: Implantable loop recorder
Arm 2: Patient-driven portable ECG monitoringActive comparatorPatient-driven portable ECG monitoring
Receives: Device: Patient-driven portable ECG monitoring
Arm 3: Usual CareActive comparatorAll 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. Number of overall arrhythmia diagnosis

    Number of overall arrhythmia diagnosis

    Measured: 18 months

  6. 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

  7. 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.

  1. First posted11 Sep 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionJun 2029 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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)
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 26746177

  • Bhatnagar 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 35902161

  • Kober 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 42661420

  • Baez-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 39768511

  • Kwok 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 31300202

  • Jansen 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 41624560

  • Savarese 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

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.

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