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Not Yet Recruiting NCT07816458

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

Conditions: Heart Failure

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 266
Sponsor: Medisch Spectrum Twente

Location: Medisch Spectrum Twente Enschede

Summary

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07816458). StuddyBuddy aggregates publicly available trial information.