The FibroCAN study. Mineralocorticoid receptor antagonist treatment for diabetic cardiovascular autonomic neuropathy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516597-30-00

Enrollment

100

Registered

2024-11-20

Start date

2025-05-02

Completion date

Unknown

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic cardiovascular autonomic neuropathy

Brief summary

The CART E/I ratio (by the Vagustm device)

Detailed description

Cardiovascular reflex tests: R/S ratio, Valsalva manoeuvre (CARTs), HRV indices (SDNN, RMSSD, Low and high-frequency power) (by the Vagustm device), Fibrosis markers (serum PRO-C6 and C3M assessed by ELISA), Fibrosis markers in skin biopsies (Pro-C6 and C3M by immunostaining (Only week 0, 36, 78)

Interventions

DRUGFinerenone

DRUGBAY 94-8862

DRUGMatching filmcoated placebo tablets will be provided by Bayer (see 2024-516258-23-00)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The CART E/I ratio (by the Vagustm device)	—

Secondary

Measure	Time frame
Cardiovascular reflex tests: R/S ratio, Valsalva manoeuvre (CARTs), HRV indices (SDNN, RMSSD, Low and high-frequency power) (by the Vagustm device), Fibrosis markers (serum PRO-C6 and C3M assessed by ELISA), Fibrosis markers in skin biopsies (Pro-C6 and C3M by immunostaining (Only week 0, 36, 78)	—

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026