Health TrialsbyHealthPanel

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

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedisch Spectrum Twente

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Implantable loop recorder

    Device

    Hospital-driven continuous monitoring with an implantable loop recorder

  • Patient-driven portable ECG monitoring

    Device

    Patient-driven portable ECG monitoring

  • Usual Care

    Other intervention

    Usual care

Treatment groups

258 Participants
are divided into 3 treatment groups
Group A: Arm 1: Hospital-driven continuous monitoring with an implantable loop recorderActive comparator 1 intervention
Group B: Arm 2: Patient-driven portable ECG monitoringActive comparator 1 intervention
Group C: Arm 3: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
18 months

Secondary outcomes

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.

Time frame
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.

Time frame
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

Time frame
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.

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medisch Spectrum Twente

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: