Heart Failure
Conditions
Keywords
Heart Failure, Implantable loop recorder (ILR), Portable ECG, Atrial fibrillation, Care consumption
Brief 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). 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.
Interventions
DEVICEImplantable loop recorder
Hospital-driven continuous monitoring with an implantable loop recorder
DEVICEPatient-driven portable ECG monitoring
Patient-driven portable ECG monitoring
OTHERUsual Care
Usual care
Sponsors
Medisch Spectrum Twente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of unplanned cardiac care utilization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of planned cardiac care utilization | 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. |
| Time to first diagnosis of AF | 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. |
| The number of participants diagnosed with AF | 18 months | AF diagnosis will be based on ECG documentation obtained through the assigned monitoring strategy or routine clinical care |
| Pharmaceutical and/or CIED implantation management changes | 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. |
| Number of overall arrhythmia diagnosis | 18 months | Number of overall arrhythmia diagnosis |
| Quality of life Kansas City Cardiomyopathy Questionnaire | 18 months | The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months. |
| Mortality | 18 months | Mortality |
Countries
Netherlands
Contacts
CONTACTDr. Schuuring, MD PhD
Outcome results
None listed