Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT03574857
Status:
TERMINATED
Last Update Posted:
2021-02-16
First Post:
2018-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-08-15', 'mcpReleaseN': 2, 'releaseDate': '2022-07-20'}], 'estimatedResultsFirstSubmitDate': '2022-07-20'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008788', 'term': 'Metolazone'}, {'id': 'D002740', 'term': 'Chlorothiazide'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D052999', 'term': 'Quinazolinones'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D049971', 'term': 'Thiazides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-06-20', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Electrolyte disturbances', 'timeFrame': '48 hours', 'description': 'Frequency of hypokalemia, hypomagnesemia, hyponatremia'}, {'measure': 'Worsening renal function', 'timeFrame': '48 hours', 'description': "increase in serum creatinine greater that 0.5 mg/dL from the patient's baseline value on the day of the first dose of chlorothiazide or metolazone"}, {'measure': 'Hospital length of stay', 'timeFrame': 'Assessed until hospital discharge, an average of 7 days', 'description': 'Number of days hospitalized'}, {'measure': 'ICU length of stay', 'timeFrame': 'Assessed until hospital discharge, an average of 7 days', 'description': 'Number of days patient is located in an ICU'}, {'measure': 'In-hospital mortality', 'timeFrame': 'Assessed until hospital discharge, an average of 7 days', 'description': 'Incidence of in-hospital mortality'}], 'primaryOutcomes': [{'measure': 'Net urine output at 24 hours', 'timeFrame': '24 hours', 'description': 'Milliliters of urine output minus the oral plus intravenous intake'}], 'secondaryOutcomes': [{'measure': 'Net urine output at 48 hours', 'timeFrame': '48 hours', 'description': 'Milliliters of urine output minus the oral plus IV intake'}, {'measure': 'Net fluid balance over 12 hours', 'timeFrame': '24 hours', 'description': 'the net fluid balance over 12 and 24 hours prior to the addition of metolazone or chlorothiazide compared to the 12 hours after addition of the study drug'}, {'measure': 'Net fluid balance over 24 hours', 'timeFrame': '48 hours', 'description': 'Net fluid balance over 24 hours prior to the addition of metolazone or chlorothiazide compared to the 24 hours after addition of the study drug'}, {'measure': 'Weight change', 'timeFrame': '48 hours', 'description': 'Change in documented weight in kg at 48 hours after starting metolazone or chlorothiazide'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Loop diuretics', 'Heart failure', 'Diuretic resistance', 'Thiazide diuretics'], 'conditions': ['Heart Failure', 'Heart Failure With Reduced Ejection Fraction', 'Heart Failure Acute', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Admitted for acute decompensated HF with left ventricular ejection fraction (LVEF) \\<40%\n* Refractory fluid overload:\n* Unresponsive (\\<500 mL net negative over previous 24 hours) AND ineffective diuresis (determined by HF team) to moderate intensity push or low intensity continuous infusion loop diuretic (80 mg IV furosemide or equivalent bumetanide dose of 4 mg)\n* English or Spanish-speaking subjects\n* Willing and able to comply with study procedures\n\nExclusion Criteria:\n\n* Baseline thiazide use prior to admission or prior to study enrollment\n* Renal replacement therapies (RRT) or glomerular filtration rate (GFR) \\<30 mL/min at the time of enrollment\n* Pregnant women\n* Cognitive impairment\n* Prisoners\n* Left ventricular assist devices (LVAD) or temporary mechanical circulatory support devices\n* History of cardiac transplant\n* Reported allergy to thiazides\n* No enteral access or unable to take medications enterally\n* Palliative diuretics\n* Systolic blood pressure (SBP) \\<90 mm Hg prior to randomization\n* Patients receiving concomitant lithium therapy'}, 'identificationModule': {'nctId': 'NCT03574857', 'briefTitle': 'Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance', 'orgStudyIdInfo': {'id': '20455'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metolazone', 'description': 'Metolazone 5 mg by mouth once daily for 2 days', 'interventionNames': ['Drug: Metolazone Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorothiazide', 'description': 'Chlorothiazide 500 mg IV once daily for 2 days', 'interventionNames': ['Drug: Chlorothiazide Injection']}], 'interventions': [{'name': 'Metolazone Oral Tablet', 'type': 'DRUG', 'otherNames': ['Zaroxolyn'], 'description': 'Day 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO', 'armGroupLabels': ['Metolazone']}, {'name': 'Chlorothiazide Injection', 'type': 'DRUG', 'otherNames': ['Diuril'], 'description': 'Day 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV', 'armGroupLabels': ['Chlorothiazide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Emily Burns', 'investigatorAffiliation': 'University of Virginia'}}}}