Heart FailureNCT04367051
Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction
A study testing Withdrawal of Spironolactone and Continuation of spironolactone in people with Heart Failure, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Withdrawal of Spironolactone and Continuation of spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Aug 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Heart Failure
- Being tested
- Withdrawal of Spironolactone, Continuation of spironolactone
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of SpironolactoneDrug
Other recommended medications for heart failure than spironolactone will be continued for withdrawal group.
Continuation of spironolactoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Withdrawal group | Experimental | 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. Receives: Drug: Withdrawal of Spironolactone |
| Continuation group | Active comparator | Spironolactone will be continued during the study period with other medical therapy in combination. Receives: Drug: Continuation of spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of left ventricular ejection fraction
Proportion of patients with change of left ventricular ejection fraction declining more than 10%
Measured: 6 month
Secondary outcomes (5)
Numerical change of left ventricular ejection fraction
Comparison as continuous variable
Measured: 6 month
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
Measured: 6 months
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
Measured: 6 months
Rates of death, re-hospitalization or visit on emergency department for heart failure
Adverse clinical events
Measured: 6 months
results of each outcomes during extended follow-up period
change of echocardiographic parameters, clinical events, natriuretic peptide
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start13 Aug 2020
- Primary completion10 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Eun Lee, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367051
- Sponsor's protocol ID
- AMC_2020_0613
- Status last verified
- Oct 2023
- First submitted
- 27 Apr 2020
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hyun J, Lee SA, Lee SE, Hong JA, Kim MS, Kim JJ. Withdrawal of Spironolactone for Heart Failure With Improved Ejection Fraction: An Open-Label, Pilot, Randomized Controlled Trial (With-HF Trial). Korean Circ J. 2025 Dec;55(12):1077-1089. doi: 10.4070/kcj.2025.0052. Epub 2025 Jul 8.
PubMed 40736394
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04367051
- Acronym / sponsor ID
- AMC_2020_0613
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Withdrawal group | Experimental | Drug: Withdrawal of SpironolactoneSpironolactone 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. |
| Continuation group | Active comparator | Drug: Continuation of spironolactoneSpironolactone will be continued during the study period with other medical therapy in combination. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of SpironolactoneOther recommended medications for heart failure than spironolactone will be continued for withdrawal group. | Drug | Withdrawal group |
| Continuation of spironolactoneSpecific 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. | Drug | Continuation group |
Primary outcome
Change of left ventricular ejection fraction
Time frame: 6 month
Proportion of patients with change of left ventricular ejection fraction declining more than 10%
5 secondary outcomes
Numerical change of left ventricular ejection fraction
Time frame: 6 month
Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide
Time frame: 6 months
Change of serum level of biomarkers (e.g. soluble ST-2, galectin-3)
Time frame: 6 months
Rates of death, re-hospitalization or visit on emergency department for heart failure
Time frame: 6 months
results of each outcomes during extended follow-up period
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Derived from this study: PubMed 40736394Hyun J, Lee SA, Lee SE, Hong JA, Kim MS, Kim JJ. Withdrawal of Spironolactone for Heart Failure With Improved Ejection Fraction: An Open-Label, Pilot, Randomized Controlled Trial (With-HF Trial). Korean Circ J. 2025 Dec;55(12):1077-1089. doi: 10.4070/kcj.2025.0052. Epub 2025 Jul 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withdrawal of Spironolactone and Continuation of spironolactone in people with Heart Failure, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of left ventricular ejection fraction (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04367051, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.