[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540123":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":70,"centralContacts":75,"locations":86,"responsibleParty":104,"collaborators":106,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":45,"eligibilityCriteria":115,"healthyVolunteers":112,"sex":116,"minAge":117,"maxAge":45,"enrollmentInfo":118,"targetDuration":45,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":88,"whyStopped":45,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"VA Office of Research and Development","FED",[8,15,21,27,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"L-Citrulline, Then Placebo","EXPERIMENTAL","Participants will receive a 90-day supply of L-Citrulline and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity\u002Fpulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.",[13,14],"Drug: L-Citrulline","Drug: Placebo for L-Citrulline",{"label":16,"type":10,"description":17,"interventionNames":18},"BH4, Then Placebo","Participants will receive a 90-day supply of BH4 and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity\u002Fpulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.",[19,20],"Drug: BH4","Drug: Placebo for BH4",{"label":22,"type":10,"description":23,"interventionNames":24},"Atorvastatin, Then Placebo","Participants will receive a 90-day supply of Atorvastatin and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity\u002Fpulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Placebo and perform baseline and follow-up assessments as above.",[25,26],"Drug: Atorvastatin","Drug: Placebo for Atorvastatin",{"label":28,"type":10,"description":29,"interventionNames":30},"Placebo, Then L-Citrulline","Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity\u002Fpulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of L-Citrulline and perform baseline and follow-up assessments as above.",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Placebo, Then BH4","Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity\u002Fpulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of BH4 and perform baseline and follow-up assessments as above.",[19,20],{"label":36,"type":10,"description":37,"interventionNames":38},"Placebo, Then Atorvastatin","Participants will receive a 90-day supply of Placebo and perform baseline assessments of resting arterial blood pressure, ECT, arterial elasticity\u002Fpulse contour analysis, flow-mediated vasodilation and passive limb movement procedures. Participants will return to the laboratory for up to 5 additional study visits (days 10, 20, 30, 60, and 90) and repeat the experimental protocol. After a two-week washout period, participants will receive a 90-day supply of Atorvastatin and perform baseline and follow-up assessments as above.",[25,26],[40,46,50,56,60,66],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","L-Citrulline","100 mg tablet",[9,28],null,{"type":41,"name":47,"description":48,"armGroupLabels":49,"otherNames":45},"Placebo for L-Citrulline","L-Citrulline-matched Placebo tablet",[9,28],{"type":41,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"BH4","10mg\u002Fkg",[16,32],[55],"Kuvan®, sapropterin dihydrochloride",{"type":41,"name":57,"description":58,"armGroupLabels":59,"otherNames":45},"Placebo for BH4","BH4-matched Placebo",[16,32],{"type":41,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Atorvastatin","10 mg tablet",[22,36],[65],"Lipitor®",{"type":41,"name":67,"description":68,"armGroupLabels":69,"otherNames":45},"Placebo for Atorvastatin","Atorvastatin-matched Placebo",[22,36],[71],{"name":72,"affiliation":73,"role":74},"David W. Wray, PhD","VA Salt Lake City Health Care System, Salt Lake City, UT","PRINCIPAL_INVESTIGATOR",[76,82],{"name":77,"role":78,"phone":79,"phoneExt":80,"email":81},"David W Wray, PhD","CONTACT","(801) 582-1565","4162","David.Wray2@va.gov",{"name":83,"role":78,"phone":79,"phoneExt":84,"email":85},"Misti R Seppi, MBA BS AAS","4860","Misti.Seppi@va.gov",[87],{"facility":73,"status":88,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"RECRUITING","Salt Lake City","Utah","84148-0001","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-111.89105,40.76078,{"lat":98,"lon":97},[101,103],{"name":77,"role":78,"phone":102,"phoneExt":80,"email":81},"801-582-1565",{"name":72,"role":74,"phone":45,"phoneExt":45,"email":45},{"type":105,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[107],{"name":108,"class":109},"University of Utah","OTHER","100540123","phase-1-novel-approaches-for-improving-vascular-function-in-veterans-with-hfpef-100540123",false,"NCT06312748","Novel Approaches for Improving Vascular Function in Veterans With HFpEF","Inclusion Criteria:\n\n* Age 18 years or older and able to give written informed consent.\n* New York Heart Association (NYHA) functional class I, II, or III.\n* Left Ventricular Ejection Fraction (LVEF) \\> 50%.\n* Plasma Brain Natriuretic Peptide (BNP) equal to or greater than 150 pg\u002FmL or NT-proBNP equal to or greater than 600 pg\u002FmL at Visit 1, or a BNP equal to or great than 100 pg\u002FmL (or NT-proBNP equal to or greater than 400 pg\u002FmL) and a hospitalization for heart failure within the last 12 months.\n\nExclusion Criteria:\n\n* History of hypersensitivity or allergy to any lipophilic statin.\n* Prior EF \\\u003C50%.\n* NYHA Class IV.\n* Patients with HFpEF secondary to significant uncorrected primary valvular disease.\n* Active liver disease or unexplained persistent elevations in serum transaminase.\n* Women who are pregnant or may become pregnant.\n* Patients currently treated with antioxidants, nitrates, PDE-5 inhibitors, or statins.","ALL","18 Years",{"count":119,"type":120},90,"ESTIMATED","INTERVENTIONAL",[123],"PHASE1","This project will evaluate the impact of L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin administration on physical capacity and vascular function in Veterans with heart failure with preserved ejection fraction (HFpEF).",[126,127],"Heart Failure With Preserved Ejection Fraction","Inflammation",[129,130,131,132],"vascular health","exercise tolerance","HFpEF","nitric oxide","2026-04-20",{"date":135,"type":136},"2026-04-23","ACTUAL",{"date":138,"type":136},"2021-05-19",{"date":140,"type":120},"2030-09-30",{"name":5,"class":6},1]