Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-29 @ 9:56 PM
Study NCT ID:
NCT05633758
Status:
WITHDRAWN
Last Update Posted:
2022-12-01
First Post:
2022-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008788', 'term': 'Metolazone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no participants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-21', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-11-21', 'lastUpdatePostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total urinary output and negative fluid balance', 'timeFrame': '48 hours', 'description': 'Total urinary output and negative fluid balance in milliliters (ml) at 48 hours following administration of first dose of intravenous diuretic.'}], 'secondaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': 'Day 2', 'description': 'Change in weight from admission to day 2'}, {'measure': 'Degree of improvement in dyspnea', 'timeFrame': '6, 12, 24, 36, and 48 hours', 'description': 'Dyspnea assessed at 6, 12, 24, 36, and 48 hours with Modified Borg Scale (1-10)'}, {'measure': 'All cause mortality', 'timeFrame': '30 days', 'description': 'All-cause mortality at 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Decompensated Heart Failure']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.', 'detailedDescription': 'AS DESCRIBED BY THE PRINCIPAL INVESTIGATOR (DR. HEYWOOD): The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 18 years of age at time of enrollment.\n* Admitted with acute decompensated heart failure based on history, physical exam, and laboratory parameters, must include both:\n\n 1. At least 1 symptom of either dyspnea, orthopnea, or edema.\n 2. At least 1 sign of rales on auscultation, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.\n* Be willing to comply with protocol-specified instructions\n* Able to understand and grant informed consent.\n\nExclusion Criteria:\n\n* Inability to give informed consent.\n* Systolic BP \\< 90 mmHg\n* Creatinine clearance less than 20ml/min or creatinine greater than 2.5mg/dl.\n* Serum Sodium less than 128meq/L, potassium levels less than 3.5meq/L\n* Known adverse reaction to metolazone\n* Inability to take oral medications\n* Severe Aortic Stenosis (AVA \\< 0.8cm³)\n* History of Hypertrophic Obstructive Cardiomyopathy.\n* Metastatic Carcinoma\n* Severe Chronic Obstructive Pulmonary Disease (COPD), FEV \\< 1L\n* Severe dyspnea requiring prolonged CPAP or intubation\n* Moderate/Severe Dementia'}, 'identificationModule': {'nctId': 'NCT05633758', 'acronym': 'MELT-HF', 'briefTitle': 'Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Health'}, 'officialTitle': 'Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF): A Multicenter, Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'IRB-14-6311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'SOC heart failure therapy and placebo pill (Arm A)', 'description': 'This group will receive all standard heart failure therapy and placebo pill.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SOC heart failure therapy with addition of metolazone (Arm B)', 'description': 'This group will receive all standard heart failure therapy with addition of metolazone.', 'interventionNames': ['Drug: Metolazone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['NA-placebo'], 'description': 'All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of administration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose.', 'armGroupLabels': ['SOC heart failure therapy and placebo pill (Arm A)']}, {'name': 'Metolazone', 'type': 'DRUG', 'otherNames': ['NA-Metolazone'], 'description': 'All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of administration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose.', 'armGroupLabels': ['SOC heart failure therapy with addition of metolazone (Arm B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Green Torrey Pines', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'James T Heywood, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}