[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04600115":3,"trial-entities:NCT04600115":125,"trial-summary:NCT04600115":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":60,"secondary_outcomes":65,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":14,"eligibility_criteria":73,"std_ages":90,"locations":93,"central_contacts":113,"overall_officials":118,"references":123,"see_also_links":124},"NCT04600115","IRB 94980","New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)","RECRUITING","2027-03-03","2026-07","2026-07-07","2017-03-03","University of Utah","OTHER",true,"This study's main specific aims are;\n\n1. To develop robust acquisition and reconstruction methods specifically for the study of microvascular cardiac remodeling with MRI which will include very innovative quantitative perfusion methods, as well as fibrosis quantification, longitudinal strain, and phase contrast imaging for flow.\n2. Test the new methods for identifying the clinical task of characterizing HFpEF.","Heart failure with preserved ejection fraction (HFpEF) is currently being studied intensely as several large trials of drug therapies have failed to benefit patients. Better characterization of these patients is important, and there are open questions regarding microvascular disease and remodeling in the HFpEF population. New MRI methods could be ideal to better characterize and understand HFpEF and its response to treatments. This project seeks to develop, evaluate and apply new MRI methods for high-end perfusion imaging. These methods will estimate endo\u002Fepi ratios across the cardiac cycle in free-breathing studies, which will provide new information about microvascular disease. This is of particular value for assessing HFpEF.\n\nThe idea of this project is to combine new techniques for quantitative cardiac perfusion MRI imaging that would be ideally suited for answering open questions regarding HFpEF and for studying microvascular disease. The methods could potentially also predict patients who might respond to particular drug therapies.\n\nThe new techniques include \"simultaneous multi-slice\" imaging which has not been used this way for myocardial perfusion imaging. In particular, we are developing an innovative hybrid of the standard saturation pulse and steady state spoiled gradient echo acquisitions. We also are developing a new method for using 3D \"stack of stars\" + 2D slice in the same scan for arterial input function assessment to quantify perfusion, and new methods for measuring T1.",[18],"MRI Scans",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[23],"EARLY_PHASE1",{"count":25,"type":26},100,"ESTIMATED",[28,37,43,49,54],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":34},"DRUG","Adenosine","Adenosine: 0.14mg\u002Fkg\u002Fmin for 6 min. IV injection for MRI perfusion",[33],"MRI vs.PET with\u002Fwithout Cardiac disease",[35,36],"Adenoscan","Adenocard",{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Regadenoson","0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.",[33],[42],"Lexiscan",{"type":29,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"O-15 labeled radioactive water","O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging",[33],[48],"O-15 water",{"type":50,"name":51,"description":52,"armGroupLabels":53},"DEVICE","MRI","Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson",[33],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"PET Imaging","Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day",[33],[59],"Positron Emission Tomography Imaging",[61],{"measure":62,"description":63,"timeFrame":64},"Myocardial perfusion measured with MRI","Myocardial perfusion measured with Magnetic Resonance Imaging (MRI) at rest and vasodilation","Time in the scanner to be 60-90 minutes.",[66],{"measure":67,"description":68,"timeFrame":69},"ECV measures","Extracellular volume (ECV) measures from T1 mapping pre- and post-contrast","One year","ALL","18 Years",null,{"inclusion":74,"exclusion":78,"raw_text":89},[75,76,77],"All participants will be over the age of 18 and able to provide consent","Group A (volunteers, with or without cardiac disease): Volunteers will be available for at least one study visit","Group B (HFpEF patient volunteers): Volunteers will have a diagnosis of HFpEF and be safe to be imaged with MRI",[79,80,81,82,83,84,85,86,87,88],"minors","Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded.","Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl).","Patients with contraindication to MRI (metal implants, or certain types of heart valves),","pregnant patients, , mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers).","Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR\\\u003C30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents.","This threshold may be modified, depending on practices determined by the Radiology Department and the IRB.","Patients with a known allergy or contraindication to Adenosine and\u002For Regadenoson will be excluded from stress MRI cohorts.","All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each MRI","Subjects with a known contraindication to Adenosine and\u002For Regadenoson will only be enrolled in scans where no stress agent will be administered","Inclusion Criteria:\n\n* All participants will be over the age of 18 and able to provide consent\n\n  * Group A (volunteers, with or without cardiac disease): Volunteers will be available for at least one study visit\n  * Group B (HFpEF patient volunteers): Volunteers will have a diagnosis of HFpEF and be safe to be imaged with MRI\n\nExclusion Criteria:\n\n* minors\n* Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded.\n* Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl).\n* Patients with contraindication to MRI (metal implants, or certain types of heart valves),\n* pregnant patients, , mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers).\n* Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR\\\u003C30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents.\n* This threshold may be modified, depending on practices determined by the Radiology Department and the IRB.\n* Patients with a known allergy or contraindication to Adenosine and\u002For Regadenoson will be excluded from stress MRI cohorts.\n* All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each MRI\n* Subjects with a known contraindication to Adenosine and\u002For Regadenoson will only be enrolled in scans where no stress agent will be administered",[91,92],"ADULT","OLDER_ADULT",[94],{"facility":95,"status":7,"city":96,"state":97,"zip":98,"country":99,"contacts":100,"geoPoint":110},"university of Utah, Radiology Research","Salt Lake City","Utah","84108","United States",[101,106],{"name":102,"role":103,"phone":104,"email":105},"Olivia Pratt, BS","CONTACT","801-585-6142","u0447662@umail.utah.edu",{"name":107,"role":103,"phone":108,"email":109},"Collin Arsenault, BS","801-587-8638","Collin.arsenault@hsc.utah.edu",{"lat":111,"lon":112},40.76078,-111.89105,[114,115],{"name":102,"role":103,"phone":104,"email":105},{"name":116,"role":103,"phone":108,"email":117},"Collin Arsenault, BS.","collin.arsenault@hsc.utah.edu",[119],{"name":120,"affiliation":121,"role":122},"Edward DiBella, Ph.D.","Faculty","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":126,"biomarkers":130},[127,128,129],"Healthy Volunteers","Heart Disorder","Heart failure with normal ejection fraction",[],{"nct_id":4,"found":14,"summary":132,"prompt_version":142},{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This interventional study plans to enroll 100 participants. It is not specified if the study is randomized or blinded.","completed","New MRI Methods for Heart Failure with Preserved Ejection Fraction (HFpEF)","This study is exploring new ways to use MRI (Magnetic Resonance Imaging) to better understand heart failure with preserved ejection fraction (HFpEF). Researchers are testing new MRI techniques, along with medications like Adenosine or Regadenoson, and O-15 labeled radioactive water for PET imaging. The goal is to improve how we characterize HFpEF and understand microvascular disease in these patients. Success will be measured by how well these new MRI methods can measure blood flow to the heart muscle. You may be able to join if you are over 18, with or without heart disease, or have a diagnosis of HFpEF and can safely undergo an MRI. The current status of this study is unclear.","Not specified.",114,"You would undergo MRI scans at rest and during hyperemia (increased blood flow) caused by Adenosine or Regadenoson. You would also have PET imaging with O-15 labeled radioactive water on a different day. The MRI scan itself is expected to take 60-90 minutes.","Not stated in the trial record.",[30,38,44,51,55],"v2"]