Key result
Sacubitril/valsartan significantly increased the total clinical effective rate to 93.3% compared to 75.6% with ACEI/ARB therapy in maintenance hemodialysis patients with HFpEF.
Why the study?
Heart failure is common in maintenance hemodialysis (MHD) patients, with HFpEF being the main cause, but effective therapies are lacking and the effect of sacubitril/valsartan in this population remains unclear.
Does sacubitril/valsartan improve clinical symptoms, cardiac function, and exercise tolerance compared to ACEI/ARB in maintenance hemodialysis patients with HFpEF?
RCT (n=90)
Random number method
No
Does sacubitril/valsartan improve clinical symptoms, cardiac function, and exercise tolerance compared to ACEI/ARB in maintenance hemodialysis patients with HFpEF?
Absolute Event Rate: 93.3% vs 75.6%
p-value: p=0.020
Sacubitril/valsartan significantly improves clinical symptoms, cardiac function, and exercise tolerance compared to ACEI/ARB therapy in maintenance hemodialysis patients with HFpEF, while demonstrating a favorable safety profile.
May support sacubitril/valsartan in hemodialysis HFpEF; leaves open confirmation in larger randomized trials.
Background : Heart failure (HF) is a common comorbidity in maintenance hemodialysis (MHD) patients, of which ejection fraction preserved heart failure (HFpEF) is the main cause, resulting in substantial mortality and morbidity. However, there are still no effective therapeutic agents available for HFpEF. Sacubitril/valsartan (SV) has been shown to significantly improve clinical symptoms and reverse ventricular remodeling in patients with reduced ejection fraction of heart failure (HFrEF). The effect of SV in MHD patients with HFpEF remains unclear. Our study aimed to evaluate the efficacy and safety of SV in MHD patients with HFpEF. Methods : A total of 90 MHD patients with HFpEF admitted to the Department of Nephrology of Hefei Second People's Hospital from January 2021 to January 2022 were collected, and they were divided into control group and observation group according to random number method. Both groups received consistent basic treatment based on the results of the test, and at this baseline, one group received ACEI/ARB drugs as the control group, and the other group received SV as the observation group. The starting dose of SV was 50mg bid, and the dose was gradually increased according to blood pressure and blood potassium level until the target dose of 100mg bid was reached for 3 months.After 3 months of treatment, relevant indicators before and after treatment, such as NYHA grade, echocardiography related indicators, NT-proBNP, 6 minute walking distance (6 MWD), blood pressure level, serum potassium and incidence of adverse reactions, were collected and compared. Results : 1. A total of 90 patients with MHD and HFpEF, no patients stopped during the follow-up. There were no significant differences in general clinical data (age, number of months of dialysis, sex, primary disease), NYHA grade, serum NT-proBNP, serum potassium, blood creatinine, hemoglobin, LVEF, 6 MWD, SBP and DBP between the two groups (all P> 0.05).2. After 3 months of treatment, in terms of treatment effect, 41 people were significantly effective, 35 were effective and 14 were ineffective. The efficacy of the observation group was significantly higher than that of the control group, and the difference was statistically significant (P <0.05).3. After 3 months of treatment, LVEF in both groups increased significantly, LVEDD, LVESD, LVEDV, E/e' and PAP decreased compared with the previous group, and the difference before and after treatment in the observation group was more significant than that in the control group, and the difference before and after treatment in both groups was statistically significant (all P<0.05). The LVESV also decreased in both groups, and the difference between the observation group before and after treatment was statistically significant (P<0.05), while the difference between the control group was not statistically significant (P>0.05). 4.After 3 months of treatment, the 6MWD of patients in both groups increased compared with the previous group, and the NT-proBNP decreased compared with the previous group, and the difference before and after treatment in the observation group was higher than that in the control group, and the difference before and after treatment in both groups was statistically significant (both P<0.05). 5. After 3 months of treatment, the average SBP and DBP of the two groups decreased significantly compared with the previous group, and the difference before and after treatment in the observation group was significantly higher than that in the control group, and the difference before and after treatment between the two groups was statistically significant (both P<0.05); There was no significant change in serum potassium levels before and after treatment, and there was no significant difference (all P>0.05). 6. During the treatment follow-up process, the incidence of adverse reactions in the observation group was lower than that in the control group, and the difference was statistically significant (P <0.05). Conclusion : Our study shows that SV is effective and safe in the treatment of MHD patients with HFpEF.
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Zhao et al. (2023) conducted an RCT in Maintenance hemodialysis with HFpEF (n=90). Sacubitril/valsartan vs. ACEI/ARB was evaluated on Total effective rate (based on clinical symptoms and NYHA grade improvement) (p=0.020). Sacubitril/valsartan significantly increased the total clinical effective rate to 93.3% compared to 75.6% with ACEI/ARB therapy in maintenance hemodialysis patients with HFpEF.
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