Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Launched by PETER ROSSING · Mar 25, 2025

Keywords

ClinConnect Summary

The FibroCAN Study is a clinical trial looking at a medication called finerenone to see if it can help treat a serious condition known as cardiovascular autonomic neuropathy (CAN) in people with type 2 diabetes. CAN affects how the heart and blood vessels work and can lead to significant health issues, including heart disease and kidney damage. This study will involve 100 participants aged 40 and older who have type 2 diabetes and specific test results indicating early-stage CAN. Participants will be randomly assigned to receive either finerenone or a placebo (a harmless pill with no active medication) for 78 weeks.

To join this study, individuals must provide consent and meet certain health criteria, such as having type 2 diabetes and specific test results for CAN. However, those with certain heart conditions, severe respiratory disease, or who are pregnant or breastfeeding cannot participate. Throughout the study, participants will be monitored to see how well the treatment works and whether it has any effects on other types of nerve-related issues. This trial is vital as it may offer new hope for managing a challenging complication of diabetes, but please note that the study is not yet recruiting participants.

Gender

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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