Alert-HF: Early Detection and Intervention on Atrial Fibrillation in Heart Failure Patients (Alert-HF)

September 7, 2026 updated by: Medisch Spectrum Twente

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

258

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients with HF and no history of documented AF on electrocardiogram (ECG) are eligible.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder
Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder (ILR)
Device: Implantable loop recorder
Hospital-driven continuous monitoring with an implantable loop recorder
Active Comparator: Arm 2: Patient-driven portable ECG monitoring
Patient-driven portable ECG monitoring
Device: Patient-driven portable ECG monitoring
Patient-driven portable ECG monitoring
Active Comparator: Arm 3: Usual Care
All patients are treated according to the ESC guidelines (ESC HF 2026).6 The data flow includes peri-odic outpatient utilization.
Other: Usual Care
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of planned cardiac care utilization
Time Frame: 18 months
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.
18 months
Time to first diagnosis of AF
Time Frame: 18 months
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.
18 months
The number of participants diagnosed with AF
Time Frame: 18 months
AF diagnosis will be based on ECG documentation obtained through the assigned monitoring strategy or routine clinical care
18 months
Pharmaceutical and/or CIED implantation management changes
Time Frame: 18 months
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.
18 months
Number of overall arrhythmia diagnosis
Time Frame: 18 months
Number of overall arrhythmia diagnosis
18 months
Quality of life Kansas City Cardiomyopathy Questionnaire
Time Frame: 18 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months.
18 months
Mortality
Time Frame: 18 months
Mortality
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medisch Spectrum Twente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

September 7, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alert-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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