The study is a randomized controlled pilot trial to evaluate whether withdrawal of spironolactone is safe and associated with re-deterioration of left ventricular function in patients with heart failure with improved ejection fraction. The aim of current trial is to test the hypothesis that withdrawal of spironolactone would not be associated with relapse of significant clinical deterioration of left ventricular systolic function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Other recommended medications for heart failure than spironolactone will be continued for withdrawal group.
Specific dose of spironolactone for continuation group is on each physician's discretion with acceptable range of 12.5 mg - 50 mg once or twice daily.
Asan Medical Center
Seoul, Songpa-gu, South Korea
Change of left ventricular ejection fraction
Proportion of patients with change of left ventricular ejection fraction declining more than 10%
Time frame: 6 month
Numerical change of left ventricular ejection fraction
Comparison as continuous variable
Time frame: 6 month
Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide
Each serum level transformed with a log value and comparing with baseline level
Time frame: 6 months
Change of serum level of biomarkers (e.g. soluble ST-2, galectin-3)
Serum biomarkers such as soluble ST-2, galectin-3 are checked and compared with baseline value for prediction of decreased left ventricular ejection fraction
Time frame: 6 months
Rates of death, re-hospitalization or visit on emergency department for heart failure
Adverse clinical events
Time frame: 6 months
results of each outcomes during extended follow-up period
change of echocardiographic parameters, clinical events, natriuretic peptide
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.