[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cardiovascular-autonomic-neuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cardiovascular-autonomic-neuropathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100585723","phase-2-finerenone-treatment-for-diabetic-cardiovascular-autonomic-neuropathy-the-fibrocan-study-100585723",false,"NCT06906081","Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study","FibroCAN","To be included in this study the participants must fulfill the following inclusion criteria.\n\n* Given informed consent\n* Type 2 diabetes defined by WHO criteria\n* Aged 40 ≥ at inclusion\n* Pathological E\u002FI ratio (Mean value of three measures)\n\nExclusion criteria Participants will be excluded in one or more of the following criteria are met.\n\n* No CAN (no abnormal CARTs)\n* Definite CAN (more than one abnormal CART)\n* HbA1C \\>100 mmol\u002FL\n* Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient's primary physician, who is not involved in this study, will determine if discontinuation is possible.\n* Atrial fibrillation\u002Fflutter\n* Congestive heart failure (NYHA class 3-4)\n* History of cardiac arrhythmia\n* Severe forms of respiratory disease including asthma and COPD\n* Any nondiabetic cause of neuropathy\n* All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A).\n* Severe hepatic impairment\n* Lactose intolerance\n* Breastfeeding\n* Nephropathy requiring dialysis\n* Beta-blocker-use\n* Hyperkalemia at screening visit (plasma potassium \\>4.8 mmol\u002Fl)\n* eGFR \\\u003C 25 ml\u002Fmin\u002F1.73m2\n* Potassium plasma \\> 4.8 mmol\u002Fl (at randomization)\n* Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit\n* Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit\n* Have received chemotherapeutic treatment within last 12 months\n* Grapefruit consumption that cannot be discontinued during the study period\n* Inability to complete study protocol, assessed to investigator\n* Not able to read, write and\u002For understand Danish","ALL","40 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Diabetic neuropathy is a serious and common complication of diabetes that currently has no cure. One form of this condition is cardiovascular autonomic neuropathy (CAN), which affects about 20% of people with diabetes-an estimated 100 million people worldwide. CAN is a significant risk factor for death and health problems like heart disease and kidney damage, and may contribute to the high rates of cardiovascular-related deaths in people with diabetes.\n\nThis study is a double-blind, randomized, placebo-controlled, two-center trial. The study aims to test whether finerenone can treat cardiovascular autonomic neuropathy in patients with type 2 diabetes. The trial will evaluate the effects of 78 weeks of treatment with finerenone or a placebo, assigned randomly in a 1:1 ratio, on early-stage cardiovascular autonomic neuropathy. The trial will include 100 participants with type 2 diabetes. Additionally, the study will investigate how the treatment impacts other types of neuropathy and related pathological mechanisms.",[26,27,28],"Cardiovascular Autonomic Neuropathy","Type 2 Diabetes","Diabetic Neuropathies",[30,31,27,32],"Mineralocorticoid receptor antagonist (MRA)","Cardiovascular autonomic neuropathy","Diabetic Neuropathy","RECRUITING","2025-05-23",{"date":36,"type":37},"2025-05-25","ACTUAL",{"date":39,"type":37},"2025-05-02",{"date":41,"type":20},"2028-01",{"name":43,"class":44},"Peter Rossing","OTHER",2]