None listed
Conditions
Interventions
Drug : Eligible subjects providing written informed consent will be randomly assigned in a ratio of 1:1 to either spironolactone withdrawal group or continuation group. Randomization will be performed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rates of LVEF decline after 6months | — |
Secondary
| Measure | Time frame |
|---|---|
| BNP/ Change of NT-proBNP | — |
Countries
Korea, Republic of
Contacts
Public ContactMihyeon Hwang
Asan Medical Center
Outcome results
None listed