finerenone treatment for diabetic cardiovascular autonomic neuropathy: the fibrocan study

Conditions: Cardiovascular Autonomic Neuropathy; Type 2 Diabetes; Diabetic Neuropathies

Summary: 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. this 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.


Eligibility criteria:
to be included in this study the participants must fulfill the following inclusion criteria. * given informed consent * type 2 diabetes defined by who criteria * aged 40 ≥ at inclusion * pathological e/i ratio (mean value of three measures) exclusion criteria participants will be excluded in one or more of the following criteria are met. * no can (no abnormal carts) * definite can (more than one abnormal cart) * hba1c \>100 mmol/l * 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. * atrial fibrillation/flutter * congestive heart failure (nyha class 3-4) * history of cardiac arrhythmia * severe forms of respiratory disease including asthma and copd * any nondiabetic cause of neuropathy * 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). * severe hepatic impairment * lactose intolerance * breastfeeding * nephropathy requiring dialysis * beta-blocker-use * hyperkalemia at screening visit (plasma potassium \>4.8 mmol/l) * egfr \< 25 ml/min/1.73m2 * potassium plasma \> 4.8 mmol/l (at randomization) * treatment with strong cyp3a4-inhibitors (e.g. itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit * 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 * have received chemotherapeutic treatment within last 12 months * grapefruit consumption that cannot be discontinued during the study period * inability to complete study protocol, assessed to investigator * not able to read, write and/or understand danish

Keywords: mineralocorticoid receptor antagonist (mra) cardiovascular autonomic neuropathy type 2 diabetes diabetic neuropathy