Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction

Not Applicable

Completed

Interventions: Drug: Continuation of spironolactone
Drug: Withdrawal of Spironolactone

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Willing and capable of providing informed consent and agrees to follow the study protocol and schedule of clinical follow-up
Age between 19 and 80 years old
Prior diagnosis of heart failure with reduced left ventricular ejection fraction (LV EF ≤ 35%) and on medical therapy including spironolactone combined with angiotensin-converting enzyme or angiotensin receptor blocker or antiotensin receptior neprilysin blocker, beta-blocker.
LV EF ≥ 50% documented with echocardiography performed within a month
Documented result of BNP or NT-proBNP level within a month

Exclusion Criteria

Dyspnea ≥ New York Heart Association (NYHA) functional class III
Patients who need to discontinue spironolactone owing to prior adverse event
Primary valvular heart disease with at least moderate degree
Estimated glomerular filtration rate less than 30 mL/min per 1.73 m2
Uncontrolled hypertension defined as blood pressure more than 140/90 mmHg
Presence of other clinical reason to continue spironolactone such as myocardial infarction, primary aldosteronism, and liver cirrhosis
Hyperkalemia defined as serum potassium level less than 3.5 mmol per liter
Pregnant and/or lactating women
Life expectancy less than a year
Patients who are not suitable to enrollment by investigator's discretion

Arm && Interventions

Group	Intervention	Description
Continuation group	Continuation of spironolactone	Spironolactone will be continued during the study period with other medical therapy in combination.
Withdrawal group	Withdrawal of Spironolactone	Spironolactone will be discontinued in patients who were receiving optimal medical therapy including angiotensin-converting enzyme or angiotensin receptor blocker or angiotensin receptor neprilysin, beta-blocker, and spironolactone.

Primary Outcome Measures

Name	Time	Method
Change of left ventricular ejection fraction	6 month	Proportion of patients with change of left ventricular ejection fraction declining more than 10%

Secondary Outcome Measures

Name	Time	Method
Numerical change of left ventricular ejection fraction	6 month	Comparison as continuous variable
Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide	6 months	Each serum level transformed with a log value and comparing with baseline level
Change of serum level of biomarkers (e.g. soluble ST-2, galectin-3)	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
Rates of death, re-hospitalization or visit on emergency department for heart failure	6 months	Adverse clinical events
results of each outcomes during extended follow-up period	2 years	change of echocardiographic parameters, clinical events, natriuretic peptide

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