Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT04367051
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2020-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of left ventricular ejection fraction', 'timeFrame': '6 month', 'description': 'Proportion of patients with change of left ventricular ejection fraction declining more than 10%'}], 'secondaryOutcomes': [{'measure': 'Numerical change of left ventricular ejection fraction', 'timeFrame': '6 month', 'description': 'Comparison as continuous variable'}, {'measure': 'Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide', 'timeFrame': '6 months', 'description': 'Each serum level transformed with a log value and comparing with baseline level'}, {'measure': 'Change of serum level of biomarkers (e.g. soluble ST-2, galectin-3)', 'timeFrame': '6 months', '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'}, {'measure': 'Rates of death, re-hospitalization or visit on emergency department for heart failure', 'timeFrame': '6 months', 'description': 'Adverse clinical events'}, {'measure': 'results of each outcomes during extended follow-up period', 'timeFrame': '2 years', 'description': 'change of echocardiographic parameters, clinical events, natriuretic peptide'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '40736394', 'type': 'DERIVED', 'citation': '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 Jul 8. doi: 10.4070/kcj.2025.0052. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and capable of providing informed consent and agrees to follow the study protocol and schedule of clinical follow-up\n* Age between 19 and 80 years old\n* 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.\n* LV EF ≥ 50% documented with echocardiography performed within a month\n* Documented result of BNP or NT-proBNP level within a month\n\nExclusion Criteria:\n\n* Dyspnea ≥ New York Heart Association (NYHA) functional class III\n* Patients who need to discontinue spironolactone owing to prior adverse event\n* Primary valvular heart disease with at least moderate degree\n* Estimated glomerular filtration rate less than 30 mL/min per 1.73 m2\n* Uncontrolled hypertension defined as blood pressure more than 140/90 mmHg\n* Presence of other clinical reason to continue spironolactone such as myocardial infarction, primary aldosteronism, and liver cirrhosis\n* Hyperkalemia defined as serum potassium level less than 3.5 mmol per liter\n* Pregnant and/or lactating women\n* Life expectancy less than a year\n* Patients who are not suitable to enrollment by investigator's discretion"}, 'identificationModule': {'nctId': 'NCT04367051', 'briefTitle': 'Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Withdrawal of Spironolactone Treatment for Heart Failure With Improved Left Ventricular Ejection Fractraction: an Open-label Randomized Controlled Pilot Study (With-HF Trial)', 'orgStudyIdInfo': {'id': 'AMC_2020_0613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Withdrawal group', '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.', 'interventionNames': ['Drug: Withdrawal of Spironolactone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Continuation group', 'description': 'Spironolactone will be continued during the study period with other medical therapy in combination.', 'interventionNames': ['Drug: Continuation of spironolactone']}], 'interventions': [{'name': 'Withdrawal of Spironolactone', 'type': 'DRUG', 'description': 'Other recommended medications for heart failure than spironolactone will be continued for withdrawal group.', 'armGroupLabels': ['Withdrawal group']}, {'name': 'Continuation of spironolactone', 'type': 'DRUG', '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.", 'armGroupLabels': ['Continuation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor of medicine', 'investigatorFullName': 'Sang Eun Lee', 'investigatorAffiliation': 'Asan Medical Center'}}}}