Heart Failure Clinical Trial
Official title:
A Multi-center, Randomized, Open-label, Active-controlled, 12-week Study to Evaluate the Efficacy and Safety of Sacubitril/Valsartan in Maintenance Hemodialysis Patients With Heart Failure
Sacubitril/valsartan reduces the risk of cardiovascular mortality among patients with heart
failure with reduced ejection fraction, and has been recently indicated as a new treatment
option with a strong level of recommendation (class I, level of evidence B) in the main
international guidelines. Cardiovascular disease (CVD) is the most common cause of death in
end stage renal disease (ESRD) patients undergoing hemodialysis (HD). Hence, treatments to
improve mortality and specifically cardiovascular outcomes in this population are greatly
needed. So far, no data available about the efficacy and safety of sacubitril/valsartan in
ESRD patients undergoing hemodialysis, although this medication was noted to be effective and
comparably well tolerable in those with estimated glomerular filtration rate(eGFR) 20 to 60
mL/min/1.73 m2 in the United Kingdom Heart and Renal Protection-III trial.
The purpose of this open label, randomized controlled study with prospective data collection
is to assess the efficacy and safety of sacubitril/valsartan in maintenance hemodialysis
patients with heart failure.
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