Objective:The purpose of this study is to evaluate the therapeutic effectiveness and safety of dapagliflozin in patients with HFrEF and HFpEF who do not have diabetes,on the standard basic medication of chronic heart failure.Methods:This was a prospective randomized single-center trial.From September,2020 to October,2020,60 chronic heart failure patients without diabetic who were diagnosed in the Department of Cardiology in Shanxi Provincial People’s Hospital were recruited.According to Chinese Heart Failure Diagnosis and Therapy 2018,patients were categorized into two groups basing on their left ventricular ejection fraction(LVEF)respectively : HFrEF group(LVED<40%)and HFpEF group(LVED≥50%).Both HFrEF and HFpEF groups were divided into experimental groups(n=15 patients)and control groups(n=15 patients)respectively by random number table method.Patients in the experimental group received standard basic heart failure treatment plus dapagliflozin 10 mg,whereas those in their respective control group received standard basic heart failure treatment plus placebo.After one month of treatment,changes in heart rate,blood pressure,plasma N-terminal forebrain natriuretic peptide(NT-prob NP),KCCQ score,left anteroposterior atrial diameter(LAD),left ventricular end-diastolic diameter(LVEDD),left ventricular ejection fraction(LVEF),and left ventricular mass index(LVMI)were observed in the HFrEF and HFpEF groups.Results:1.Gender,age,height,weight,BMI,blood pressure,heart rate,e GFR,medication history,and previous history were not significantly different between the HFrEF and the HFpEF experimental groups and control groups before dapagliflozin treatment(P >0.05).2.A total of 59 people were included after a one-month follow-up,and one person in the HFrEF control group who had lost contact was eliminated.Comparied to their respcective control groups,both HFrEF and the HFpEF experimental groups’ systolic blood pressure and NT-pro BNP level decreased(P<0.05),KCCQ score level increased(P < 0.05)and heart rate did not change significantly(P>0.05).After 1 month of treatment,compared to previous self-parameters,LAD,LVEDD,LVEF,and LVMI in the HFrEF experimental group were lower,while LAD decreased and LVEDD、 LVEF、LVMI did not change significantly in the HFpEF experimental group.Furthermore,when compared to their respective control groups,there were no statistical difference for those parameters in HFrEF and the HFpEF experimental groups(P > 0.05).3.During a month of dapagliflozin therapy,no adverse events such as hypotension,hypoglycemia or urinary tract infection were seen in the HFrEF and HFpEF experimental groups.Conclusion:For patients in HFrEF and HFpEF experimental groups,dapagliflozin enhanced short-term 1 month quality of life and reduced blood pressure without raising heart rate.However,there were no short-term statistically significant improvement in terms of LAD,LVEDD,LVEF,and LVMI,and long-term follow-up observation was necessary. |