ArticleJACC. Heart failure2025
Symptoms Burden as a Clinical Outcomes Assessment in Heart Failure Patients With Atrial Fibrillation.
Article in JACC. Heart failure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01970501 (GENETIC-AF - A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients With Heart Failure), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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GENETIC-AF - A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients With Heart Failure
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7 authors.
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Abstract
backgroundSafe and effective pharmacologic therapy for atrial fibrillation (AF) in heart failure (HF) is an unmet need. In AF clinical trials, the standard primary endpoint of time to first symptomatic AF event (TTFSE) has several disadvantages, which could theoretically be overcome by measurement of AF-specific symptoms burden during an entire follow-up period.
objectivesThe authors sought to develop and validate a method of measuring symptom burden of AF in a HF population.
methodsThe authors constructed a patient-reported outcome instrument (AFSQ [Atrial Fibrillation Symptoms Questionnaire]) to function in the setting of AF/HF, and used it to measure symptoms throughout long-term follow-up. The AFSQ queries the presence of 10 new or worsening symptoms, equally divided between those associated with AF or HF. In a 267 patient AF/HF trial comparing 2 AF prevention treatments, the AFSQ was linked to electrocardiography documented AF to form a 2-component clinical outcome assessment (SxB
resultsSxB
conclusionsMeasurement of symptoms burden throughout clinical trial follow-up is feasible in AF/HF and should be useful for evaluating patient-centered outcomes in AF prevention trials. (Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure [GENETIC-AF]; NCT01970501).
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