Finerenone treatment for cardiovascular issues in diabetes
Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
This study is testing if a medication called finerenone can help people with type 2 diabetes who have early signs of heart and nerve problems feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Drugs / interventions | CART |
| Locations | 2 sites (Gistrup and 1 other locations) |
| Trial ID | NCT06906081 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of finerenone, a mineralocorticoid receptor antagonist, in treating cardiovascular autonomic neuropathy (CAN) in patients with type 2 diabetes. It is a double-blind, randomized, placebo-controlled trial involving 100 participants over 78 weeks. The study aims to determine if finerenone can improve symptoms of early-stage CAN and assess its impact on other types of neuropathy. Participants will be randomly assigned to receive either finerenone or a placebo.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 and older with type 2 diabetes and early-stage cardiovascular autonomic neuropathy.
Not a fit: Patients with definite cardiovascular autonomic neuropathy or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cardiovascular health and reduce complications for patients with type 2 diabetes suffering from CAN.
How similar studies have performed: While the approach of using finerenone is novel for treating CAN, similar studies targeting diabetic neuropathies have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gistrup and 1 other locations
- Steno Diabetes Center Northern Denmark — Gistrup, Denmark (Recruiting)
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Peter Rossing, Professor, MD — Steno Diabetes Center Copenhagen
- Study coordinator: Peter Rossing, Professor, MD
- Email: peter.rossing@regionh.dk
- Phone: +4530913383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.