Abstract
This study aimed to analyze the outcomes, outcome domains, and prevalence of the use of clinical outcome endpoints (COE) in clinical trials on sodium-glucose cotransporter 2 (SGLT2) inhibitors for chronic heart failure (CHF) registered on ClinicalTrials.gov and compare them to COE for cardiovascular trials. We conducted a cross-sectional methodological study. Trials and trial outcomes were extracted from ClinicalTrials.gov, classified, and analyzed. For pivotal trials, registrations were compared with matching publications and supplementary documentation. The adherence of outcomes in pivotal clinical trials to COE developed by the European Society of Cardiology (ESC) was checked. In 71 included trials we found 170 individual clinical outcomes and divided them into 11 groups (10 clinical outcome groups, and ESC COE). Heart failure with reduced ejection fraction (HFrEF) was analyzed in 33 (46%) trials, and heart failure with preserved ejection fraction (HFpEF) in 25% of trials. ESC COE outcomes were used in less than 30% of trials, and only in 9 as primary outcomes (13%). Trials included 59 different biomarker endpoints. Patient-reported outcomes were highly heterogeneous, utilizing various non-validated questionnaires. All five pivotal trials used primary outcomes from ESC COE. The adherence of pivotal trials to the ESC COE was moderately high, with insufficient data on dyspnea and heart failure events such as intensification of diuretic therapy. All pivotal trials had at least one change in study protocol at one point during the trial, in outcome measures, statistical model, enrollment, or trial duration. Outcomes used in CHF trials of SGLT2 inhibitors were highly heterogeneous. Core outcome sets developed especially for CHF were underutilized. Standardization of outcomes is needed in the CHF field to enable between-trial comparisons and evidence syntheses.
Published Version
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