Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
NCT Number: NCT04367051
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.
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Notify Me19 year–80 year
All sexes
Interventional
Not applicable
Seoul, Songpa-gu, 138-736, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 month
Proportion of patients with change of left ventricular ejection fraction declining more than 10%
Time frame: 6 month
Comparison as continuous variable
Time frame: 6 months
Each serum level transformed with a log value and comparing with baseline level
Time frame: 6 months
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
Adverse clinical events
Time frame: 2 years
change of echocardiographic parameters, clinical events, natriuretic peptide
Asan Medical Center
Other
Withdrawal of Spironolactone Treatment for Heart Failure With Improved Left Ventricular Ejection Fractraction: an Open-label Randomized Controlled Pilot Study (With-HF Trial)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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