[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494556":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":62,"collaborators":65,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":18,"eligibilityCriteria":76,"healthyVolunteers":73,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":18,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Northwestern University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Thirty individuals will be randomized to dapagliflozin 10mg to be taken daily for six months.",[13],"Drug: Dapagliflozin 10 MG [Farxiga]",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care group","NO_INTERVENTION","Thirty individuals will be randomized to standard of care treatment.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Dapagliflozin 10 MG [Farxiga]","10mg (milligram) tablet to be taken orally once daily for 6 months. Manufacturer: Astrazeneca. Study drug will be stored and dispensed by the Interventional Drug Service Pharmacy at Northwestern University.",[9],[26],{"name":27,"affiliation":28,"role":29},"Rupal Mehta, MD","Northwestern Univeristy","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","(312) 503-1536","rupal.mehta@northwestern.edu",{"name":36,"role":32,"phone":37,"phoneExt":18,"email":38},"Tamara Isakova, MD","(312) 503-6921","tamara.isakova@northwestern.edu",[40],{"facility":5,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Chicago","Illinois","60607","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-87.65005,41.85003,{"lat":51,"lon":50},[54,57,59,60],{"name":55,"role":32,"phone":56,"phoneExt":18,"email":34},"Rupal C Mehta, MD","312-503-1536",{"name":36,"role":32,"phone":58,"phoneExt":18,"email":38},"312-926-2000",{"name":27,"role":29,"phone":18,"phoneExt":18,"email":18},{"name":36,"role":61,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":29,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Rupal Mehta","Doctor of Medicine",[66,69],{"name":67,"class":68},"National Institutes of Health (NIH)","NIH",{"name":70,"class":68},"National Heart, Lung, and Blood Institute (NHLBI)","100494556","phase-1-effect-of-dapagliflozin-on-metabolomics-and-cardiac-mechanics-in-chronic-kidney-disease-100494556",false,"NCT05719714","Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease","Inclusion Criteria:\n\n1. \\>18 years of age\n2. eGFR 25-60 ml\u002Fmin\u002F1,73m2 (eGFR = estimated glomerular filtration rate)\n3. On stable doses of diuretics and\u002For angiotensin converting enzyme inhibitor or angiotensin receptor blocker\n4. Evidence of subclinical heart failure with preserved ejection fraction at their pre-exercise echocardiogram (defined as meeting 3\u002F5 of the American Society of Echocardiography (ASE) criteria for diastolic dysfunction \\[septal e'\\\u003C7 cm\u002Fwc, average E\u002Fe' ratio\\>14, left atrial volume index \\>34 mL\u002Fm2, and peak TR velocity \\>2.8 m\u002Fsec\\] or absolute left ventricular longitudinal strain \\\u003C 18%, left atrial reservoir strain (LARS) \\\u003C 25% on 2d speckle tracking echocardiography), lack of augmentation of LVLS or LARS during exercise, or peak VO2 Females: ≤ 18 mL\u002Fkg\u002Fmin, peak VO2 Males: ≤ 20 mL\u002Fkg\u002Fmin on cardiopulmonary exercise testing.\n\nExclusion Criteria:\n\n1. presence or history of diabetes\n2. coronary revascularization within the last 6 months\n3. hemodynamically significant valvular disease\n4. significant lung disease requiring home oxygen\n5. angina (chest pain)\n6. non-revascularized myocardial ischemia\n7. systolic BP \\\u003C100 or \\>180 mmHg\n8. pregnancy\n9. clinical heart failure symptoms\n10. history of systemic disease processes that can cause HFpEF such as amyloidosis or sarcoidosis\n11. any musculoskeletal or chronic condition that will interfere with completion of cardiac testing\n12. active cancer\n13. immunosuppressive therapy\n14. baseline or pre-exercise echocardiogram demonstrates a reduced ejection fraction \\\u003C 50%\n15. currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy\n16. Hypersensitivity to a SGLT2i\n17. Pre-existing liver disease\n18. ALT\u002FAST\\> 3x normal (ALT = alanine aminotransferase AST = aspartate aminotransferase)\n19. history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months","ALL","18 Years","85 Years",{"count":81,"type":82},60,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","The goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to standard of care on heart and lung function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with chronic kidney disease.",[89,90,91,92],"Chronic Kidney Diseases","Heart Failure With Preserved Ejection Fraction","Kidney Diseases","Heart Failure",[94,95,96],"kidney","heart failure","kidney diseases","2026-04-06",{"date":99,"type":100},"2026-04-13","ACTUAL",{"date":102,"type":100},"2024-01-16",{"date":104,"type":82},"2026-09-30",{"name":5,"class":6},1]