Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Given informed consent

• Type 2 diabetes defined by WHO criteria

• Aged 40 ≥ at inclusion

• Pathological E/I ratio (Mean value of three measures)

Locations
Other Locations
Denmark
Steno Diabetes Center Northern Denmark
RECRUITING
Gistrup
Steno Diabetes Center Copenhagen
NOT_YET_RECRUITING
Herlev
Contact Information
Primary
Peter Rossing, Professor, MD
peter.rossing@regionh.dk
+4530913383
Backup
Christian Stevns Hansen, Ph.D, MD
christian.stevns.hansen@regionh.dk
+4561671618
Time Frame
Start Date: 2025-05-02
Estimated Completion Date: 2028-01
Participants
Target number of participants: 100
Treatments
Placebo_comparator: Placebo
Experimental: Finerenone (active)
Sponsors
Collaborators: Steno Diabetes Center Nordjylland, Aarhus University Hospital
Leads: Peter Rossing

This content was sourced from clinicaltrials.gov