Introduction:
Cardiovascular disease affects more than half of dialysis patients and is the leading cause of death. Sacubitril-valsartan (SV) forms part of standard of care (SOC) for heart failure, however its use in advanced CKD is uncertain. Our pilot RCT aims to evaluate the efficacy and safety of SV in dialysis patients with systolic and diastolic dysfunction.
Methods:
In this open label, stratified randomized trial (based on ejection fraction), we assigned 100 hemodialysis patients with systolic or diastolic dysfunction to receive SV (starting dose 50mg) along with SOC or SOC alone. All the patients were given thrice weekly hemodialysis and standard of care for chronic kidney disease. The primary outcome was a composite of cardiovascular death, acute coronary events, hospitalization for heart failure and all-cause mortality. The secondary outcomes included changes in echocardiographic parameters and changes in NYHA (New York Heart Association) scoring. Safety outcomes included hypotension and serious hyperkalemia.
Results:
Over 6 months, there was significant improvement in NYHA scoring at 6 months in the SV group versus SOC (24% vs 0, p = 0.0002). The risk of primary outcome (RR = 0.54, 95% CI:0.31 to 0.94, p=0.023) and risk of all-cause mortality (RR= 0.27, 95% CI: 0.09 to 0.75, p= 0.005) were significantly lower in SV group. There was no significant difference in the echocardiographic parameters in the two groups. The safety outcomes – hypotension (14% Vs 26%) and serious hyperkalemia episodes (10% Vs 0%) were comparable in SV and SOC groups, likely due to limited sample size.
Conclusions:
Sacubitril-Valsartan lowers the risk of cardiovascular events in patients with end-stage kidney disease and cardiac dysfunction compared to current SOC with comparable safety profiles. There was no significant difference in echocardiographic parameters.
I have no potential conflict of interest to disclose.
I did not use generative AI and AI-assisted technologies in the writing process.