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

Heart Failure Clinical Trial

Official title:

Withdrawal of Spironolactone Treatment for Heart Failure With Improved Left Ventricular Ejection Fractraction: an Open-label Randomized Controlled Pilot Study (With-HF Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04367051
• Other study ID #: AMC_2020_0613
• Status: Completed
• Phase: N/A
• Start date: August 13, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 30, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Withdrawal of Spironolactone
Other recommended medications for heart failure than spironolactone will be continued for withdrawal group.
• Continuation of spironolactone
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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of left ventricular ejection fraction	Proportion of patients with change of left ventricular ejection fraction declining more than 10%	6 month
Secondary	Numerical change of left ventricular ejection fraction	Comparison as continuous variable	6 month
Secondary	Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide	Each serum level transformed with a log value and comparing with baseline level	6 months
Secondary	Change of serum level of biomarkers (e.g. soluble ST-2, galectin-3)	Serum biomarkers such as soluble ST-2, galectin-3 are checked and compared with baseline value for prediction of decreased left ventricular ejection fraction	6 months
Secondary	Rates of death, re-hospitalization or visit on emergency department for heart failure	Adverse clinical events	6 months
Secondary	results of each outcomes during extended follow-up period	change of echocardiographic parameters, clinical events, natriuretic peptide	2 years