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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Continuation group | Active Comparator | Spironolactone will be continued during the study period with other medical therapy in combination. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Withdrawal of Spironolactone | Drug | Other recommended medications for heart failure than spironolactone will be continued for withdrawal group. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of left ventricular ejection fraction | Proportion of patients with change of left ventricular ejection fraction declining more than 10% | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical change of left ventricular ejection fraction | Comparison as continuous variable | 6 month |
| Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Songpa-gu | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40736394 | Derived | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Continuation of spironolactone | Drug | 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. |
|
Each serum level transformed with a log value and comparing with baseline level
| 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 | 6 months |
| Rates of death, re-hospitalization or visit on emergency department for heart failure | Adverse clinical events | 6 months |
| results of each outcomes during extended follow-up period | change of echocardiographic parameters, clinical events, natriuretic peptide | 2 years |