CHAPTER 2.1 16 METHODS Data sources Based on a collaboration with industry partners through the BigData@Heart Consortium11, data access to patient level information was obtained for five randomized clinical trials in HFrEF patients.. BEAUTIFUL and SHIFT were ivabradine trials (n= 15732)12,13, FAIR-HF and CONFIRM were studies on intravenous iron supplementation (n=763)14,15 and PANTHEON was a trial for neladenosone bialanate (n=427).16 Of these, three were phase III trials, one was phase II and lastly, one phase IV study. All RCTs included HFrEF patients based on left ventricular ejection fraction (LVEF) values (ranging from ≤ 35 to ≤ 45%) except for the BEAUTIFUL study, which recruited coronary artery disease (CAD) patients who had left ventricular dysfunction. To maintain comparability between patients from the RCTs, only patients with New York Heart Association (NYHA) class II-IV from BEAUTIFUL (n=9227) were included. Aggregated data from both treatment and placebo arms of each RCT were pooled and compared against the HFrEF population from two observational data sources: the CHECK-HF and the SwedeHF registries.17,18 Detailed information on the methods for both registries can be found elsewhere.17,18 Briefly, the CHECK-HF registry included patients with chronic HF if they had an HF diagnosis based on ESC 2012 guidelines between 2013 and 2016.17 The ongoing SwedeHF registry enrolled patients with clinician-judged HF patients in Sweden.18 For the current analysis, outpatients registered between 2000 to 2016 (n=40 230) were included to ensure consistency with CHECK-HF. Data from both registries were combined for describing patient characteristics and treatment but only SwedeHF data was used in the reporting on clinical outcomes because CHECK-HF did not have follow-up data. For each of the five trials, ethics approval and written informed consent were obtained by the respective study investigators.12–16 CHECK-HF registry was granted ethics approval for anonymised analysis of existing patient data, while in the SwedeHF registry, enrolment was based on specific health centres’ participation and patients allowed to opt-out should they wish not to participate.17,18
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