Status:
COMPLETED
Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction
Lead Sponsor:
Asan Medical Center
Conditions:
Heart Failure
Eligibility:
All Genders
19-80 years
Phase:
NA
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 failu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04367051
Start Date
August 13 2020
End Date
June 30 2022
Last Update
October 5 2023
Active Locations (1)
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1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 138-736