Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
Recruiting · NCT06906081 · Interventional (participants receive a specific treatment) · Lead sponsor: Peter Rossing
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
2 locations listed.
- Steno Diabetes Center Northern Denmark - Gistrup, Denmark
- Steno Diabetes Center Copenhagen - Herlev, Denmark