Nctid:
NCT00000525
Payload:
{"FullStudy"=>{"Rank"=>474370, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000006973", "ConditionMeshTerm"=>"Hypertension"}, {"ConditionMeshId"=>"D000002318", "ConditionMeshTerm"=>"Cardiovascular Diseases"}, {"ConditionMeshId"=>"D000006331", "ConditionMeshTerm"=>"Heart Diseases"}, {"ConditionMeshId"=>"D000006323", "ConditionMeshTerm"=>"Heart Arrest"}, {"ConditionMeshId"=>"D000016757", "ConditionMeshTerm"=>"Death, Sudden, Cardiac"}, {"ConditionMeshId"=>"D000003645", "ConditionMeshTerm"=>"Death, Sudden"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000014652", "ConditionAncestorTerm"=>"Vascular Diseases"}, {"ConditionAncestorId"=>"D000003643", "ConditionAncestorTerm"=>"Death"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9109", "ConditionBrowseLeafName"=>"Heart Diseases", "ConditionBrowseLeafAsFound"=>"Heart Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9714", "ConditionBrowseLeafName"=>"Hypertension", "ConditionBrowseLeafAsFound"=>"Hypertension", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9101", "ConditionBrowseLeafName"=>"Heart Arrest", "ConditionBrowseLeafAsFound"=>"Heart Arrest", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6535", "ConditionBrowseLeafName"=>"Death", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4143", "ConditionBrowseLeafName"=>"Arrhythmias, Cardiac", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M18808", "ConditionBrowseLeafName"=>"Death, Sudden, Cardiac", "ConditionBrowseLeafAsFound"=>"Death, Sudden, Cardiac", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6537", "ConditionBrowseLeafName"=>"Death, Sudden", "ConditionBrowseLeafAsFound"=>"Death, Sudden", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17090", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000006852", "InterventionMeshTerm"=>"Hydrochlorothiazide"}, {"InterventionMeshId"=>"D000002752", "InterventionMeshTerm"=>"Chlorthalidone"}, {"InterventionMeshId"=>"D000014223", "InterventionMeshTerm"=>"Triamterene"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000959", "InterventionAncestorTerm"=>"Antihypertensive Agents"}, {"InterventionAncestorId"=>"D000004232", "InterventionAncestorTerm"=>"Diuretics"}, {"InterventionAncestorId"=>"D000045283", "InterventionAncestorTerm"=>"Natriuretic Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000049993", "InterventionAncestorTerm"=>"Sodium Chloride Symporter Inhibitors"}, {"InterventionAncestorId"=>"D000049990", "InterventionAncestorTerm"=>"Membrane Transport Modulators"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000062686", "InterventionAncestorTerm"=>"Epithelial Sodium Channel Blockers"}, {"InterventionAncestorId"=>"D000026941", "InterventionAncestorTerm"=>"Sodium Channel Blockers"}, {"InterventionAncestorId"=>"D000062865", "InterventionAncestorTerm"=>"Diuretics, Potassium Sparing"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M9600", "InterventionBrowseLeafName"=>"Hydrochlorothiazide", "InterventionBrowseLeafAsFound"=>"Oral tablet", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M5683", "InterventionBrowseLeafName"=>"Chlorthalidone", "InterventionBrowseLeafAsFound"=>"Enteric-", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M7101", "InterventionBrowseLeafName"=>"Diuretics", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M16666", "InterventionBrowseLeafName"=>"Triamterene", "InterventionBrowseLeafAsFound"=>"Recombinant human chorionic gonadotropin", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3967", "InterventionBrowseLeafName"=>"Antihypertensive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25842", "InterventionBrowseLeafName"=>"Sodium Chloride Symporter Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M22867", "InterventionBrowseLeafName"=>"Sodium Channel Blockers", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M29715", "InterventionBrowseLeafName"=>"Diuretics, Potassium Sparing", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Antihypertensive Agents", "InterventionBrowseBranchAbbrev"=>"AnAg"}, {"InterventionBrowseBranchName"=>"Natriuretic Agents", "InterventionBrowseBranchAbbrev"=>"NaAg"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Channel Blockers", "InterventionBrowseBranchAbbrev"=>"ChanBlk"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}}, "EnrollmentInfo"=>{"EnrollmentType"=>"Actual", "EnrollmentCount"=>"233"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"July 1986"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"September 2013", "LastUpdateSubmitDate"=>"September 18, 2013", "StudyFirstSubmitDate"=>"October 27, 1999", "StudyFirstSubmitQCDate"=>"October 27, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"September 19, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"October 28, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"September 1989", "PrimaryCompletionDateType"=>"Actual"}}, "OversightModule"=>{}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Cardiovascular Diseases", "Death, Sudden, Cardiac", "Heart Arrest", "Heart Diseases", "Hypertension"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"2138408", "ReferenceType"=>"background", "ReferenceCitation"=>"Siegel D, Cheitlin MD, Black DM, Seeley D, Hearst N, Hulley SB. Risk of ventricular arrhythmias in hypertensive men with left ventricular hypertrophy. Am J Cardiol. 1990 Mar 15;65(11):742-7. doi: 10.1016/0002-9149(90)91381-f."}, {"ReferencePMID"=>"1746997", "ReferenceType"=>"background", "ReferenceCitation"=>"Chang SW, Fine R, Siegel D, Chesney M, Black D, Hulley SB. The impact of diuretic therapy on reported sexual function. Arch Intern Med. 1991 Dec;151(12):2402-8."}, {"ReferencePMID"=>"1734646", "ReferenceType"=>"background", "ReferenceCitation"=>"Siegel D, Black DM, Seeley DG, Hulley SB. Circadian variation in ventricular arrhythmias in hypertensive men. Am J Cardiol. 1992 Feb 1;69(4):344-7. doi: 10.1016/0002-9149(92)90231-m."}, {"ReferencePMID"=>"1735925", "ReferenceType"=>"background", "ReferenceCitation"=>"Siegel D, Hulley SB, Black DM, Cheitlin MD, Sebastian A, Seeley DG, Hearst N, Fine R. Diuretics, serum and intracellular electrolyte levels, and ventricular arrhythmias in hypertensive men. JAMA. 1992 Feb 26;267(8):1083-9."}, {"ReferencePMID"=>"1615875", "ReferenceType"=>"background", "ReferenceCitation"=>"Siegel D, Cheitlin MD, Seeley DG, Black DM, Hulley SB. Silent myocardial ischemia in men with systemic hypertension and without clinical evidence of coronary artery disease. Am J Cardiol. 1992 Jul 1;70(1):86-90. doi: 10.1016/0002-9149(92)91395-k."}, {"ReferencePMID"=>"8206564", "ReferenceType"=>"background", "ReferenceCitation"=>"Siegel D, Saliba P, Haffner S. Glucose and insulin levels during diuretic therapy in hypertensive men. Hypertension. 1994 Jun;23(6 Pt 1):688-94. doi: 10.1161/01.hyp.23.6.688."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine whether hypertensive patients with ECG abnormalities and receiving hydrochlorothiazide diuretics were at increased risk of sudden death.", "DetailedDescription"=>"BACKGROUND:\n\nThe Multiple Risk Factor Intervention Trial (MRFIT) revealed an unexpected subgroup finding: an association between diuretic therapy (especially with hydrochlorothiazide) and an increased rate of sudden death in hypertensive men with left ventricular hypertrophy and other ECG abnormalities. The Diuretics, Hypertension, and Arrhythmias Clinical Trial sought to determine whether the finding resulted from random variation or represented a serious toxic response to hydrochlorothiazide.\n\nDESIGN NARRATIVE:\n\nRandomized, double-blind. Following one month of withdrawal from all diuretics and repletion with oral potassium and magnesium, the study participants were randomized to two months of treatment with one of six treatment groups: hydrochlorothiazide; hydrochlorothiazide with oral potassium; hydrochlorothiazide with oral potassium and magnesium; hydrochlorothiazide and triamterene; chlorthalidone; or placebo. The main outcome measures were ventricular arrhythmias on 24-hour Holter monitoring and serum and intracellular potassium and magnesium levels."}, "EligibilityModule"=>{"Gender"=>"Male", "MaximumAge"=>"70 years", "MinimumAge"=>"35 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Men, ages 35 to 70, with ECG abnormalities, diastolic blood pressure less than 95 mm Hg at entry.\n\nSubjects had been treated for at least six months by their own physicians with hydrochlorothiazide (HCT), HCT and potassium supplementation, triamteren"}, "IdentificationModule"=>{"NCTId"=>"NCT00000525", "BriefTitle"=>"Diuretics, Hypertension, and Arrhythmias Clinical Trial", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"University of California, San Francisco"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"44"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01HL036821", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01HL036821", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"hydrochlorothiazide", "InterventionType"=>"Drug"}, {"InterventionName"=>"diet, potassium supplementation", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"diet, magnesium supplementation", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"triamterene", "InterventionType"=>"Drug"}, {"InterventionName"=>"chlorthalidone", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Stephen Hulley", "OverallOfficialAffiliation"=>"University of California"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"University of California, San Francisco", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "CollaboratorClass"=>"NIH"}]}}}}}}
