Heart Failure With Reduced Ejection Fraction Clinical Trial
Official title:
Assessment of Clinical Effect and Treatment Quality of Rapid Release Carvedilol Versus SLOW Release Carvedilol-SR in HEART FAILURE Patient (SLOW-HF): A Prospective Randomized, Open-label, Multicenter Study
Assessment of clinical effect and treatment quality of immediate release carvedilol (IR) versus slow release carvedilol (SR) in patients with HFrEF
The SLOW-HF trial is a phase 4, randomized, open label, multicenter study to evaluate the
therapeutic efficacy of carvedilol-SR compared to carvedilol-IR in patients with heart
failure with reduced ejection fraction. Patients with stable HFrEF will be randomly assigned
(1:1) to carvedilol SR group (160 patients) and carvedilol IR group (160 patients).
After randomization, patients will be followed for 6 months. The primary endpoint is the
change in NT-proBNP level from baseline to the study end. The secondary endpoints include the
frequency of NT-proBNP increment >10% from baseline, composite of all-cause mortality and
readmission, mortality rate, readmission rate, changes in blood pressure, quality of life,
and drug compliance.
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