Nctid:
NCT00001629
Payload:
{"FullStudy"=>{"Rank"=>473360, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 01, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000006333", "ConditionMeshTerm"=>"Heart Failure"}, {"ConditionMeshId"=>"D000009203", "ConditionMeshTerm"=>"Myocardial Infarction"}, {"ConditionMeshId"=>"D000050197", "ConditionMeshTerm"=>"Atherosclerosis"}, {"ConditionMeshId"=>"D000007238", "ConditionMeshTerm"=>"Infarction"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000014652", "ConditionAncestorTerm"=>"Vascular Diseases"}, {"ConditionAncestorId"=>"D000002318", "ConditionAncestorTerm"=>"Cardiovascular Diseases"}, {"ConditionAncestorId"=>"D000006331", "ConditionAncestorTerm"=>"Heart Diseases"}, {"ConditionAncestorId"=>"D000007511", "ConditionAncestorTerm"=>"Ischemia"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000009336", "ConditionAncestorTerm"=>"Necrosis"}, {"ConditionAncestorId"=>"D000017202", "ConditionAncestorTerm"=>"Myocardial Ischemia"}, {"ConditionAncestorId"=>"D000001161", "ConditionAncestorTerm"=>"Arteriosclerosis"}, {"ConditionAncestorId"=>"D000001157", "ConditionAncestorTerm"=>"Arterial Occlusive Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9111", "ConditionBrowseLeafName"=>"Heart Failure", "ConditionBrowseLeafAsFound"=>"Heart Failure, Congestive", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6236", "ConditionBrowseLeafName"=>"Coronary Artery Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M19196", "ConditionBrowseLeafName"=>"Myocardial Ischemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6239", "ConditionBrowseLeafName"=>"Coronary Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9714", "ConditionBrowseLeafName"=>"Hypertension", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11845", "ConditionBrowseLeafName"=>"Myocardial Infarction", "ConditionBrowseLeafAsFound"=>"Myocardial Infarction", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9972", "ConditionBrowseLeafName"=>"Infarction", "ConditionBrowseLeafAsFound"=>"Infarction", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M14668", "ConditionBrowseLeafName"=>"Respiratory Tract Infections", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M25878", "ConditionBrowseLeafName"=>"Atherosclerosis", "ConditionBrowseLeafAsFound"=>"Atherosclerosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17090", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9109", "ConditionBrowseLeafName"=>"Heart Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10233", "ConditionBrowseLeafName"=>"Ischemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11974", "ConditionBrowseLeafName"=>"Necrosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4159", "ConditionBrowseLeafName"=>"Arteriosclerosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4155", "ConditionBrowseLeafName"=>"Arterial Occlusive Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Infections", "ConditionBrowseBranchAbbrev"=>"BC01"}, {"ConditionBrowseBranchName"=>"Respiratory Tract (Lung and Bronchial) Diseases", "ConditionBrowseBranchAbbrev"=>"BC08"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000000804", "InterventionMeshTerm"=>"Angiotensin II"}, {"InterventionMeshId"=>"C000627694", "InterventionMeshTerm"=>"Giapreza"}, {"InterventionMeshId"=>"D000000808", "InterventionMeshTerm"=>"Angiotensinogen"}, {"InterventionMeshId"=>"D000047228", "InterventionMeshTerm"=>"Angiotensin II Type 1 Receptor Blockers"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000014662", "InterventionAncestorTerm"=>"Vasoconstrictor Agents"}, {"InterventionAncestorId"=>"D000015842", "InterventionAncestorTerm"=>"Serine Proteinase Inhibitors"}, {"InterventionAncestorId"=>"D000011480", "InterventionAncestorTerm"=>"Protease Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000057911", "InterventionAncestorTerm"=>"Angiotensin Receptor Antagonists"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M3822", "InterventionBrowseLeafName"=>"Angiotensin II", "InterventionBrowseLeafAsFound"=>"Semen", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M289298", "InterventionBrowseLeafName"=>"Giapreza", "InterventionBrowseLeafAsFound"=>"Semen", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3825", "InterventionBrowseLeafName"=>"Angiotensinogen", "InterventionBrowseLeafAsFound"=>"Semen", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M28606", "InterventionBrowseLeafName"=>"Angiotensin Receptor Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25479", "InterventionBrowseLeafName"=>"Angiotensin II Type 1 Receptor Blockers", "InterventionBrowseLeafAsFound"=>"11C-Methionine", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M17099", "InterventionBrowseLeafName"=>"Vasoconstrictor Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M14033", "InterventionBrowseLeafName"=>"Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M18081", "InterventionBrowseLeafName"=>"Serine Proteinase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M19299", "InterventionBrowseLeafName"=>"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T18", "InterventionBrowseLeafName"=>"Serine", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Vasoconstrictor Agents", "InterventionBrowseBranchAbbrev"=>"VaCoAg"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Anti-Infective Agents", "InterventionBrowseBranchAbbrev"=>"Infe"}, {"InterventionBrowseBranchName"=>"Amino Acids", "InterventionBrowseBranchAbbrev"=>"AA"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignPrimaryPurpose"=>"Treatment"}, "EnrollmentInfo"=>{"EnrollmentCount"=>"49"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"July 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"June 1999", "CompletionDateStruct"=>{"CompletionDate"=>"September 2000"}, "LastUpdateSubmitDate"=>"March 3, 2008", "StudyFirstSubmitDate"=>"November 3, 1999", "StudyFirstSubmitQCDate"=>"December 9, 2002", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"March 4, 2008", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"December 10, 2002", "StudyFirstPostDateType"=>"Estimate"}}, "OversightModule"=>{}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Angiotensin AT-1 Receptor", "Angiotensin Receptor Antagonist", "Atherosclerosis", "Blood Flow", "Cold Pressor Test", "Endothelium", "Exercise", "Coronary Artery Disease", "Heart Failure"]}, "ConditionList"=>{"Condition"=>["Atherosclerosis", "Heart Failure, Congestive", "Hypertension", "Myocardial Infarction"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"7505360", "ReferenceType"=>"background", "ReferenceCitation"=>"Cockcroft JR, Sciberras DG, Goldberg MR, Ritter JM. Comparison of angiotensin-converting enzyme inhibition with angiotensin II receptor antagonism in the human forearm. J Cardiovasc Pharmacol. 1993 Oct;22(4):579-84. doi: 10.1097/00005344-199310000-00011."}, {"ReferencePMID"=>"8491505", "ReferenceType"=>"background", "ReferenceCitation"=>"Goldberg MR, Tanaka W, Barchowsky A, Bradstreet TE, McCrea J, Lo MW, McWilliams EJ Jr, Bjornsson TD. Effects of losartan on blood pressure, plasma renin activity, and angiotensin II in volunteers. Hypertension. 1993 May;21(5):704-13. doi: 10.1161/01.hyp.21.5.704."}, {"ReferencePMID"=>"8383016", "ReferenceType"=>"background", "ReferenceCitation"=>"Sudhir K, MacGregor JS, Gupta M, Barbant SD, Redberg R, Yock PG, Chatterjee K. Effect of selective angiotensin II receptor antagonism and angiotensin converting enzyme inhibition on the coronary vasculature in vivo. Intravascular two-dimensional and Doppler ultrasound studies. Circulation. 1993 Mar;87(3):931-8. doi: 10.1161/01.cir.87.3.931."}]}}, "DescriptionModule"=>{"BriefSummary"=>"The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve both endothelial dysfunction and metabolic coronary vasodilation, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on endothelial function are also partly due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity.", "DetailedDescription"=>"The renin angiotensin system (RAS) plays an important physiological and pathophysiological role in the control of blood pressure and plasma volume. Inhibition of the RAS is useful in the treatment of hypertension, cardiac failure and in some patients with myocardial infarction. Several recent clinical trials with angiotensin converting enzyme inhibitors (ACEI) have shown that they also reduce the incidence of myocardial infarction, but the mechanisms underlying this anti-ischemic effect are poorly understood. ACEI reduce angiotensin II synthesis and prevent bradykinin degradation. Results from ongoing studies in the Cardiology Branch (Protocol 95-H-0099) designed to investigate the link between ACEI and the vascular endothelium indicate that ACEI improve both endothelial dysfunction and metabolic coronary vasodilation, an effect that is partially mediated by bradykinin. The current protocol is designed to investigate whether the beneficial effects of ACEI on endothelial function are also partly due to inhibition of angiotensin II. The recent development of selective angiotensin II type 1 (AT1) receptor antagonists allows us to specifically examine the effects of angiotensin II on vasomotor activity."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Patient must be over 18 years of age requiring diagnostic cardiac catheterization will participate.\n\nWomen on chronic estrogen therapy are eligible for the study.\n\nPatients investigated for chest pain syndrome with normal coronary arteries with and without risk factors for atherosclerosis, patients with coronary artery disease, and patients with heart failure.\n\nNo patients with unstable angina; significant left main disease (greater than 50% stenosis); Recent myocardial infarction (less than 1 month); Pregnancy, lactation; Allergy to losartan; Renal failure (creatinine greater than 2.5 mg/dl); Inability to withdraw ACE inhibitors."}, "IdentificationModule"=>{"NCTId"=>"NCT00001629", "BriefTitle"=>"The Role of Angiotensin Type I Receptor in the Regulation of Human Coronary Vascular Function", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institutes of Health Clinical Center (CC)"}, "OfficialTitle"=>"The Role of Angiotensin Type I Receptor in the Regulation of Human Coronary Vascular Function", "OrgStudyIdInfo"=>{"OrgStudyId"=>"970142"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"97-H-0142"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Angiotensin II type 1 receptor antagonists", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20892", "LocationCity"=>"Bethesda", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"National Heart, Lung and Blood Institute (NHLBI)"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
