Study of Finerenone to Treat Cardiovascular Autonomic Neuropathy in People with Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the potential of finerenone to treat cardiovascular autonomic neuropathy CAN, a serious complication affecting about 20% of people with type 2 diabetes. CAN increases the risk of heart disease, kidney damage, and death, and this phase 2, double-blind, randomized, placebo-controlled trial aims to better understand if finerenone can improve early-stage CAN and other neuropathies in patients with type 2 diabetes. Participants will receive either finerenone or a placebo for 78 weeks. The finerenone dosage will be adjusted based on kidney function and potassium levels, starting at 10mg, 20mg, or 40mg daily as tablets taken by mouth. Those with better kidney function start higher and may increase dose if potassium levels allow. The study will compare changes between the finerenone group and the placebo group over this treatment period. During the trial, participants will attend visits at screening, baseline, and at weeks 12, 24, 36, 52, and 78. Tests will measure heart rate variability, responses to cardiovascular autonomic reflex tests, and fibrosis markers in blood and skin biopsies. Researchers will monitor safety, medication adherence, and neuropathy progression. The study will last about 78 weeks per participant, with ongoing assessments to evaluate finerenones effects on CAN and related conditions.

Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study