Tests finerenone for nerve damage affecting the heart in type 2 diabetes

Trial details

Who runs it

Peter Rossing

Trial code

NCT06906081EU 2024-516597-30-00

Record updated

25 May 2025

Original description

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.Read full original descriptionShow less

Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

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.

Exclusion: 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; Congestive heart failure (NYHA class 3-4); History of cardiac arrhythmia; Severe forms of respiratory disease including asthma and COPD; Severe hepatic impairment; 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; Hyperkalemia at screening visit (plasma potassium >4.8 mmol/l); eGFR < 25 ml/min/1.73m2; Potassium plasma > 4.8 mmol/l (at randomization); No CAN (no abnormal CARTs); Definite CAN (more than one abnormal CART); Atrial fibrillation/flutter; 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); Lactose intolerance; Breastfeeding; Nephropathy requiring dialysis; Beta-blocker-use; 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.

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).

ClinicalTrials.gov NCT06906081 · EU CTIS 2024-516597-30-00