[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05174052":3,"trial-entities:NCT05174052":105,"trial-summary:NCT05174052":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":68,"locations":71,"central_contacts":90,"overall_officials":100,"references":103,"see_also_links":104},"NCT05174052","13694","Dapagliflozin in Patients With Atrial Fibrillation (DAPA-AF)","Dapagliflozin in Patients With Atrial Fibrillation","RECRUITING","2027-12","2026-03","2026-04-01","2022-06-01","University of Oklahoma","OTHER",false,"The study will investigate the effect of Dapagliflozin on atrial fibrillation (AF) burden. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months, quality of life (QOL) and validated echocardiographic indices of atrial myopathy. This knowledge will enable us to study the therapeutic potential of SGLT2i as a novel adjunct treatment for patients with DM and AF. Patients with paroxysmal AF (AF that terminates spontaneously or with intervention within seven days of onset) and DM and randomize them to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden will be used, measure of QOL with the help of AF Effect on Quality-of-life survey and perform an echocardiogram with measurement of left atrial volume index, left atrial strain and atrial tissue dopplers. All measurements will be performed at baseline and at study completion. The central hypothesis is that SGLT2i will lead to reduced AF burden that will translate into improvement in QOL, and the underlying mechanism is improvement in atrial myopathy.","Patients with diabetes mellitus (DM) and atrial fibrillation (AF) represent a high-risk cohort that is at an increased risk of cardiovascular complications as compared to AF patients without DM. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are a new class of diabetic drugs and large clinical trials have established their multiple cardiovascular benefits. However, none of these clinical trials studied AF as a primary outcome. SGLT2i have multiple properties that can be protective against AF and the role of SGLT2i in preventing recurrent AF remains an important knowledge gap.\n\nIn this translational research proposal, we aim to fill this knowledge gap by studying the effect of Dapagliflozin on AF burden. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months, quality of life (QOL) and validated echocardiographic indices of atrial myopathy. This knowledge will enable us to study the therapeutic potential of SGLT2i as a novel adjunct treatment for patients with DM and AF. Patients with paroxysmal AF (AF that terminates spontaneously or with intervention within seven days of onset) and DM will be enrolled. Subjects will be randomized to Dapagliflozin or placebo. Continuous heart rhythm monitoring patch for AF burden, measure QOL with the help of AF Effect on Quality-of-life survey and perform an echocardiogram with measurement of left atrial volume index, left atrial strain and atrial tissue dopplers. All measurements will be performed at baseline and at study completion. Our central hypothesis is that SGLT2i will lead to reduced AF burden that will translate into improvement in QOL, and the underlying mechanism is improvement in atrial myopathy.",[19,20],"Diabetes Mellitus","Atrial Fibrillation",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},28,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Dapagliflozin 10Mg Tab","Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily.",[35],"Intervention Arm (Dapagliflozin)",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Placebo","Subjects will take 1 blinded capsule of placebo drug dosed once daily",[40],"Control Arm (Placebo)",[42],{"measure":43,"description":44,"timeFrame":45},"The effect of Dapagliflozin on change in burden of atrial fibrillation","To determine the effect of Dapagliflozin on change in AF burden in patients with AF and DM. AF burden will be defined as the percent of time spent in AF over a 2-week period, assessed by noninvasive continuous heart rhythm monitoring at baseline and at 3 months. The AF burden between Dapagliflozin vs Placebo will be compared.","Baseline and 3 months",[47],{"measure":48,"description":49,"timeFrame":45},"Effect of Dapagliflozin on change in AF Effect on Quality of Life Survey","To determine the effect of Dapagliflozin on change in quality of life in patients with AF and DM. AF Effect on Quality of Life Survey will be used to compare QOL between Dapagliflozin vs Placebo.","ALL","18 Years","85 Years",{"inclusion":54,"exclusion":57,"raw_text":67},[55,56],"Diagnosed with DM","Paroxysmal AF",[58,59,60,61,62,63,64,65,66],"Type 1 DM,","Symptoms of hypotension or systolic blood pressure \\\u003C90mmHg,","Severe renal impairment with eGFR\\\u003C30mL\u002Fminute\u002F1.73m2,","History of lower limb amputation,","Hypersensitivity to Dapagliflozin,","Currently taking any SGLT2i,","Pregnancy,","Currently taking anti-arrhythmic drugs","Undergoing catheter ablation will be excluded","Inclusion Criteria:\n\n* Diagnosed with DM\n* Paroxysmal AF\n\nExclusion Criteria:\n\n* Type 1 DM,\n* Symptoms of hypotension or systolic blood pressure \\\u003C90mmHg,\n* Severe renal impairment with eGFR\\\u003C30mL\u002Fminute\u002F1.73m2,\n* History of lower limb amputation,\n* Hypersensitivity to Dapagliflozin,\n* Currently taking any SGLT2i,\n* Pregnancy,\n* Currently taking anti-arrhythmic drugs\n* Undergoing catheter ablation will be excluded",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":87},"University of Oklahoma Health Sciences Center","Oklahoma City","Oklahoma","73104","United States",[79,84],{"name":80,"role":81,"phone":82,"email":83},"Antwanya Shaw","CONTACT","405-271-9060","Antwanya-Shaw-1@ouhsc.edu",{"name":85,"role":86},"Zain Asad, MD","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},35.46756,-97.51643,[91,96],{"name":92,"role":81,"phone":93,"phoneExt":94,"email":95},"Aurora Vera","405-271-8001","45319","Aurora-Vera@ouhsc.edu",{"name":97,"role":81,"phone":98,"email":99},"Natalia Wells-Serrano","405-271-4742","natalia-wellsserrano@ouhsc.edu",[101],{"name":102,"affiliation":13,"role":86},"Zain Ul Abideen Asad, MD",[],[],{"nct_id":4,"conditions":106,"biomarkers":107},[20,19],[],{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study where participants will be randomly assigned to receive either Dapagliflozin or a placebo. The study is blinded, meaning neither you nor your doctor will know which treatment you are receiving.","completed","Dapagliflozin for Atrial Fibrillation in Patients with Diabetes","This study is looking at how a medication called Dapagliflozin might affect atrial fibrillation (AF), a type of irregular heartbeat, in people who also have diabetes. Researchers want to see if Dapagliflozin can reduce the amount of time you spend in AF. You would take either Dapagliflozin 10mg or a placebo (an inactive pill) once a day. This study is for adults aged 18 to 85 who have been diagnosed with diabetes and paroxysmal AF (AF that stops on its own or with help within seven days). You cannot join if you have Type 1 diabetes, very low blood pressure, severe kidney problems, or are taking certain other medications. The study aims to enroll 28 participants.","The primary endpoint for measuring the effect of Dapagliflozin is at 3 months.",116,"You would take one blinded tablet daily. Your heart rhythm will be monitored continuously for two weeks at the beginning and again at three months.","Not stated in the trial record.",[37],"v2"]