Actively Recruiting
Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
Led by Peter Rossing · Updated on 2025-05-25
100
Participants Needed
2
Research Sites
139 weeks
Total Duration
On this page
Sponsors
P
Peter Rossing
Lead Sponsor
S
Steno Diabetes Center Nordjylland
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Given informed consent
- Diagnosed with type 2 diabetes according to WHO criteria
- Aged 40 years or older at inclusion
- Pathological E/I ratio measured as the mean of three tests
You will not qualify if you...
- No cardiovascular autonomic neuropathy (no abnormal CARTs)
- Definite cardiovascular autonomic neuropathy (more than one abnormal CART)
- HbA1C greater than 100 mmol/L
- Treatment with potassium-sparing diuretics or MRAs (e.g. spironolactone, eplerenone) that cannot be stopped 4 weeks before screening
- Atrial fibrillation or flutter
- Congestive heart failure (NYHA class 3-4)
- History of cardiac arrhythmia
- Severe respiratory diseases including asthma or COPD
- Any non-diabetic cause of neuropathy
- Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study
- Severe liver impairment
- Lactose intolerance
- Breastfeeding
- Nephropathy requiring dialysis
- Use of beta-blockers
- Hyperkalemia at screening (plasma potassium >4.8 mmol/l)
- eGFR less than 25 ml/min/1.73m2
- Potassium plasma > 4.8 mmol/l at randomization
- Treatment with strong CYP3A4 inhibitors or moderate to strong CYP3A4 inducers that cannot be stopped 4 weeks before screening
- Chemotherapy treatment within the last 12 months
- Grapefruit consumption that cannot be stopped during the study
- Inability to complete the study protocol as assessed by the investigator
- Not able to read, write, or understand Danish
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Steno Diabetes Center Northern Denmark
Gistrup, Denmark, 9260
Actively Recruiting
2
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
Not Yet Recruiting
Research Team
P
Peter Rossing, Professor, MD
CONTACT
C
Christian Stevns Hansen, Ph.D, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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