CHAPTER 2.2 60 patients. Drugs were the most commonly investigated intervention, accounting for 68% of phase III trials. By primary source of funding, half (51%) were industry-funded. Inclusion and exclusion criteria applied in HFrEF trials Figure 1 displays the most frequently used eligibility criteria. HFrEF trials predominantly selected participants by NYHA class (69%) while almost a quarter included patients based on previous worsening or hospitalization for heart failure (23%) and natriuretic peptide level (20%). A range of patient medical history or comorbidities were generally applied as exclusion criteria and the most common were acute coronary syndrome (64%), valvular heart disease (47%), pregnancy or lactation (44%), previous or planned implantation of cardiac devices (44%), coronary revascularization (37%), stroke (33%), respiratory disease (28%) and cancer (25%). Measures of organ dysfunction and performance status often used were renal function (55%), hepatic function (21%) and anaemia (anaemia status or hemoglobin cut-off) (17%). Also gaining importance are concomitant background treatment. Half (48%) required participants to be on standard of care medical and/or device therapies, in which a quarter specified ACEI /ARB (28%) or BB (25%) background therapy and a smaller percentage required participants to be on MRA (11%). Current use of intravenous therapy including diuretics, inotropes and vasopressors were specified in two percent of HFrEF trials, largely as exclusion criterion. Eligibility for trial enrolment by Asian and European populations To determine the proportion of patients who were trial-eligible, 2545 and 4868 patients from the BIOSTAT-CHF and Asian HF registry were included for analysis. Baseline characteristics are presented in Supplementary table 2. Compared to the Asian registry, European patients were older (median age 70 vs 61 years), more frequently in NYHA classes III or IV (38% vs 30%) and had lower prevalence of prior HF hospitalization (30% in 12 months vs 39% in 6 months). Rate of comorbidities were generally higher in European patients most notably ischaemic heart disease (68% vs 52%), AF (43% vs 18%) and COPD (17% vs 8%) with the exception of chronic renal disease (31% vs 47%). Use of HF medications between populations were similar for ACEI/ARB, BB and MRA. Almost all of the European registry patients were on
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