Back to resultsPilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Withdrawal of Spironolactone
Continuation of spironolactone
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Withdrawal group
Continuation group
Arm Description
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.
Spironolactone will be continued during the study period with other medical therapy in combination.
Outcomes
Primary Outcome Measures
Change of left ventricular ejection fraction
Proportion of patients with change of left ventricular ejection fraction declining more than 10%
Secondary Outcome Measures
Numerical change of left ventricular ejection fraction
Comparison as continuous variable
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
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
Rates of death, re-hospitalization or visit on emergency department for heart failure
Adverse clinical events
results of each outcomes during extended follow-up period
change of echocardiographic parameters, clinical events, natriuretic peptide
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04367051
Brief Title
Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 13, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Withdrawal group
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuation group
Arm Type
Active Comparator
Arm Description
Spironolactone will be continued during the study period with other medical therapy in combination.
Intervention Type
Drug
Intervention Name(s)
Withdrawal of Spironolactone
Intervention Description
Other recommended medications for heart failure than spironolactone will be continued for withdrawal group.
Intervention Type
Drug
Intervention Name(s)
Continuation of spironolactone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of left ventricular ejection fraction
Description
Proportion of patients with change of left ventricular ejection fraction declining more than 10%
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Numerical change of left ventricular ejection fraction
Description
Comparison as continuous variable
Time Frame
6 month
Title
Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide
Description
Each serum level transformed with a log value and comparing with baseline level
Time Frame
6 months
Title
Change of serum level of biomarkers (e.g. soluble ST-2, galectin-3)
Description
Serum biomarkers such as soluble ST-2, galectin-3 are checked and compared with baseline value for prediction of decreased left ventricular ejection fraction
Time Frame
6 months
Title
Rates of death, re-hospitalization or visit on emergency department for heart failure
Description
Adverse clinical events
Time Frame
6 months
Title
results of each outcomes during extended follow-up period
Description
change of echocardiographic parameters, clinical events, natriuretic peptide
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction
We'll reach out to this number within 24 hrs