Analysis of Echocardiographic Outcome Measures in Randomized Controlled Trials in Heart Failure with Preserved Ejection Fraction postprint

Abstract: Background　The selection of echocardiographic indexes for efficacy evaluation of heart failure with preserved ejection fraction（HFpEF）lacks a uniform standard. Objective　Analyze the echocardiographic outcome measures in randomized controlled trials（RCT）of HFpEF to provide a reference for the development of a standardized efficacy evaluation system for HFpEF. Methods PubMed，Embase and Cochrane Central Register of Controlled Trials were searched for RCT related to HFpEF from January 1，2021 to November 3，2023. Echocardiographic outcome measures and other information were extracted after literature screening according to eligibility criteria. The frequency and percentage of echocardiographic outcome measures were analyzed and an association rule analysis was conducted. Results　A total of 825 literatures were obtained and 14 literatures were finally included after screening. A total of 39 echocardiographic outcome measures were used in 14 studies. The minimum number of echocardiographic outcome measures used in a single study was 2，and the maximum was 18. The top 10 echocardiographic outcome measures in terms of usage frequency were ratio of mitral peak velocity of early filling（E）to mitral peak velocity of late filling（A），left ventricular ejection fraction（LVEF），average ratio of E to early diastolic mitral annular velocity（e'），left atrial volume index（LAVI），left ventricular end-diastolic diameter（LVEDD），left atrial diameter（LAD），septal E/e'，left ventricular mass index（LVMI），E deceleration time（EDT）and tricuspid annular plane systolic excursion（TAPSE）. The association rule analysis showed that when different quantitative indicators were combined，the rules with the highest support were respectively average E/e' → LAVI，LVEF+E/A → LVEDD and LAVI+average E/e'+LVEF → LVEDD. Conclusion　In HFpEF RCTs，the commonly used echocardiographic outcome measures are E/A，LVEF，and average E/e'. Moreover，LAVI and LVEDD are often used in combination with the above indicators. Lack of consistency，rationality，recognition and standardization are the problems of echocardiographic outcome measures selection in HFpEF RCTs. The development of a core outcome set may be an effective way to solve the above problems.