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While there are several completed clinical trials that address treatment strategies in patients with symptomatic and recurrent atrial fibrillation (AF), there are no randomized clinical trials that address first-line rhythm control of new-onset AF. Recent data suggest that early initiation of rhythm control within 1 year can improve outcomes. In this open-label pragmatic clinical trial nested within the Get with The Guidelines Atrial Fibrillation registry, approximately 3,000 patients with first-detected AF will be enrolled at approximately 200 sites. Participants will be randomized (1:1) to treatment with dronedarone in addition to usual care versus usual care alone. The primary endpoint will be time to first cardiovascular (CV) hospitalization or death from any cause through 12 months from randomization. Secondary endpoints will include a WIN ratio (all-cause death, ischemic stroke or systemic embolism, heart failure hospitalization, acute coronary hospitalization), CV hospitalization, and all-cause mortality. Patient reported outcomes will be analyzed based on change in Atrial Fibrillation Effect on Quality of Life (AFEQT) and change in Mayo AF-Specific Symptom Inventory (MAFSI) from baseline to 12 months. CHANGE AFIB will determine if treatment with dronedarone in addition to usual care is superior to usual care alone for the prevention of CV hospitalization or death from any cause in patients with first-detected AF. The trial will also determine whether initiation of rhythm control at the time of first-detected AF affects CV events or improves patient reported outcomes. - NCT05130268

Accepted: 29 October 2020 / Published online: 23 December 2020 © The Author(s) 2020 1 Background The 21st Century Cures and Prescription Drug User Fee (Sixth Reauthorization) Acts include provisions directing US FDA actions regarding (1) using real-world evidence (RWE) to support regulatory decision making (e.g., new indications for approved drugs) and (2) development of guidance on patient engagement in drug development [1, 2]. Specifically, the objectives were to 1. better understand patient perspectives on living with AF and anticoagulant use for reducing risk of AF-related stroke, 2. obtain patient input on outcomes considered important to patients with AF and gather feedback on endpoints commonly evaluated in previous anticoagulant RWD studies (and those being explored for future RWD studies), and 3. gain insights on opportunities to educate patients with AF and patient organizations about RWE understanding, generation, and use. [...]researchers should recognize limitations in using diagnostic codes to capture AF onset and may consider sensitivity analyses with AF onset starting with AF symptoms (e.g., gastrointestinal disorders, fatigue, syncope, anxiety) preceding a formal AF diagnosis. Obtain Input on Outcomes Important to Patients with AF The outcomes that patients agreed were most important were as follows: * Ischemic stroke-The effects of a debilitating stroke and the burden it would place on caregiver(s) (family/friends) was a significant concern * Major bleeding-Patients are most worried about bleeding not easily seen or resolved * Health-related quality of life-Patients do not want AF to hinder mobility and lifestyle 3.3 Session 3:

In Pool 19 of the Mississippi River, the fingernail clam, Sphaerium transversum, appears to feed non—selectively on phytoplankton, although green algae were in higher percentages in guts than in plankton samples. Diatoms were of paramount importance in clam guts and water samples during most sampling periods, especially from December to April when mean monthly water temperatures were less than 4 degrees C. Ingestion by clams was heaviest in spring, early summer, and fall. Clams appeared to stop ingesting when water temperatures fell to about 2—4 degrees C. In February and March, 80—90% of the clams had ceased ingesting. Ingestion did not cease simultaneously in all clams. Throughout the year some contained little or no phytoplankton. Much of the phytoplankton in the gut near the anus appeared completely undigested. Phytoplankton diversity (d) in clam guts and in water was high in July and August and low in February and March. A maximum of 33 phytoplankton genera occurred in clams in August; 38 genera were present in water samples in July and August. Concentrations of over 50,000 plankters/ml (primarily Stephanodiscus hantzschii) occurred in March 1968; minimum concentrations occurred in July.