Alert-HF: Early Detection and Intervention on Atrial Fibrillation in Heart Failure Patients
Heart Failure
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 266 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The goal of this clinical trial is to learn if using remote heart rhythm monitoring strategies can reduce unplanned cardiac care utilization and improve health-related quality of life 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) and do not have an existing pacemaker or implantable defibrillator.
The main questions the trial aims to answer are:
- Does a continuous rhythm monitor placed under the skin or a patient-driven portable home device decrease unplanned cardiac care utilization?
- Do these rhythm monitoring strategies influence therapeutic management?
- Do these rhythm monitoring strategies improve patient-reported quality of life and overall survival?
Researchers will compare two monitoring groups to a standard care group over an 18-month period to see which approach works best in heart failure treatment
Participants will:
- either have a small heart monitor placed under their chest skin for heart rhythm observation (arm 1), use a handheld device to take regular heart recordings at home (arm 2) or follow standard care (arm 3) for a period of 18 months
- Answer a health survey at the start of the study and after 18 months of follow-up.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Adult patients with HF and no history of documented AF on electrocardiogram (ECG)
Exclusion Criteria:
- Patients with CIED, such as an implantable cardioverter defibrillator (ICD), Cardiac Resynchronization Therapy Defibrillator (CRT-D), or pacemaker.
- Documented AF before inclusion
- Admission to hospices or palliative care
- Inability to communicate in Dutch or English.
- Participant under the age of 18 years old
- Participant is pregnant
- Mental disorders that, according to the treating physician, make participation unsafe
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento doble
Arm 1: Hospital-driven continuous monitoring with an implantable loop recorder
Arm 1: Hospital-driven continuous rhythm monitoring with an implantable loop recorder (ILR) placed subcutaneously in the left pectoral region.
Device: Implantable loop recorder
Arm 2: Patient-driven portable ECG monitoring
Patient-driven single-lead portable ECG monitoring in which patients are instructed to send ECG recordings of at least 30 seconds both on a scheduled routine basis and whenever experiencing symptoms suggestive of an arrhytmia.
Device: Patient-driven portable ECG monitoring
Arm 3: Usual Care
All patients are treated according to the ESC guidelines (ESC HF 2026). This includes periodic outpatient utilization.
Other: Usual Care
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
Usual care
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Number of unplanned cardiac care utilization
Plazo: 18 months
Unplanned cardiac healthcare utilization will be assessed through systematic review of patients' medical records. The number of healthcare episodes occurring during the study observation period will be recorded. Each unique healthcare episode will be classified according to the principal setting of care: outpatient clinic, daycare/day-case admission, emergency care without admission, or hospitalization. Both total and stratified care utilization will be reported.
An episode will be considered unplanned when healthcare is initiated in response to an acute, unexpected, worsening, or urgent cardiac health problem.
Healthcare episodes involving transfers between care settings as part of the same continuous episode will be counted once and classified according to the highest level of care reached, to avoid double counting.
Medidas secundarias
Number of planned cardiac care utilization
Plazo: 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 from inclusion to first diagnosis of AF
Plazo: 18 months
The clinical diagnosis of AF by a healthcare professional must be supported by ECG documentation demonstrating AF on a single-lead recording of at least 30 seconds or a standard 12-lead ECG, obtained using the assigned monitoring device or as part of routine clinical care.
The number of participants diagnosed with AF according to the electronic health rercords (EHR)
Plazo: 18 months
AF diagnosis will be established based on electrocardiographic (ECG) documentation obtained either through the assigned monitoring strategy or as part of routine clinical care, as assessed by a qualified healthcare professional.
Number of AF-related pharmacological and non-pharmacological management changes
Plazo: 18 months
Pharmacological changes include initiation, discontinuation, dose increase, dose decrease or switching of oral anticoagulants (OAC) and rate- and/or rhythm-control medications, including antiarrhythmic drugs.
Non-pharmacological interventions include electrical or pharmacological cardioversion, catheter ablation and AF-related CIED implantation or reprogramming.
The number of management changes will be grouped according to the treatment type and type of adjustment.
Number of HF-related pharmacological and non-pharmacological management changes during the study observation period.
Plazo: 18 months
Pharmacological changes include initiation, discontinuation, dose increase, dose decrease or switching of guideline-directed medical therapy (GDMT), including ARNI/ACEi/ARB, beta-blockers, mineralocorticoid receptor antagonists (MRA), sodium-glucose cotransporter-2 inhibitors (SGLT2i) and diuretics.
Non-pharmacological interventions include HF-related CIED implantation or device reprogramming.
The number of management changes will be grouped according to the treatment type and type of adjustment.
Number of overall arrhythmia diagnosis extracted from EHR
Plazo: 18 months
Number of overall arrhythmia diagnosis
Changes in Quality of life from baseline to 18 months follow-up as assessed by the Quality of life Kansas City Cardiomyopathy Questionnaire
Plazo: 18 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months.
The scores are represented on a scale from 0 to 100 points, where lower scores represent more severe symptoms and higher scores less or no symptoms.
Change in heart failure-related quality of life from baseline to 18-month follow-up, as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Plazo: 18 months
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be collected at baseline and 18 months.
The scores are represented on a scale from 0 to 100 points, where lower scores represent more severe symptoms and higher scores less or no symptoms.
Changes in overall Quality of Life from baseline to 18 months follow-up as assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Plazo: 18 months
The EQ-5D-5L is a standardized questionnaire assessing health-related quality of life across five dimensions on a score from 1 to 5, with one no problems to a score of five with extreme problems on that domain. This allows for direct comparison between baseline and follow-up. The questionnaire also includes a visual analogue scale (EQ-VAS), ranging from 0 (worst imaginable health) to 100 (best imaginable health), on which participants rate their overall health.
Furthermore, responses are used to calculate a health utility index score with values between 0 and 1. 0 indicates life valuation equal to death and one full health.
Mortality
Plazo: 18 months
Mortality
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Medisch Spectrum TwenteEnschede, NetherlandsEstado desconocido
Equipo y fechas
- Patrocinador principal
- Medisch Spectrum Twente
- Inicio del estudio
- 2027-01 Estimado
- Finalización primaria
- 2029-06 Estimado
- Finalización del estudio
- 2029-06 Estimado
- Primera publicación
- 11 sept 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Alert-HF: Early Detection and Intervention on Atrial Fibrillation in Heart Failure Patients
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026