Status:
RECRUITING
Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
Lead Sponsor:
Peter Rossing
Collaborating Sponsors:
Steno Diabetes Center Nordjylland
Aarhus University Hospital
Conditions:
Cardiovascular Autonomic Neuropathy
Type 2 Diabetes
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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 peo...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06906081
Start Date
May 2 2025
End Date
January 1 2028
Last Update
May 25 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Steno Diabetes Center Northern Denmark
Gistrup, Denmark, 9260
2
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730