Withdrawal of spironolactone treatment for heart failure with improved left ventricular ejection fraction: an open-label randomized controlled pilot study
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0005034
- Lead Sponsor
- Asan Medical Center
- Brief Summary
In this study, we confirmed that MRA can be safely discontinued in heart failure patients whose left ventricular ejection fraction has improved to over 50%, and that the risk of worsening cardiac dysfunction after stopping is low.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 62
1.Subject who was diagnosed with heart failure and reduced LV EF (HFrEF; LV EF = 35 %) and aged between 19 and
80 years old
2.Subject who was on medical therapy for heart failure management including spironolactone combined with ACEIs or
ARBs or ARNI or beta-blockers
3.LV EF = 50% documented with echocardiography performed within a month from screening period
4.Subject who has documented result of BNP or NT-proBNP level within a month from screening period
5.Subject who agrees to written consent voluntary
1.Dyspnea = New York Heart Association (NYHA) functional class III
2.Subject who needs to discontinue spironolactone owing to prior adverse event
3.Estimated glomerular filtration rate less than 30 mL/min per 1.73 m2
4.Uncontrolled hypertension defined as blood pressure more than 140/90 mmHg
5.Primary valvular heart disease with at least moderate degree
6.Presence of other clinical reason to continue spironolactone such as myocardial infarction, primary aldosteronism, and liver cirrhosis
7.Hyperkalemia defined as serum potassium level less than 3.5 mmol per liter
8.Pregnant and/or lactating women
9.Subject with life expectancy less than a year
10.Subject who is not suitable to enrollment by investigator’s discretion
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rates of LVEF decline after 6months
- Secondary Outcome Measures
Name Time Method BNP/ Change of NT-proBNP