Study on the Effects of Finerenone for Patients with Type 2 Diabetes and Early Diabetic Cardiovascular Autonomic Neuropathy

2 1

What is this study about?

The FibroCAN study is focused on understanding the effects of a medication called Finerenone on a condition known as diabetic cardiovascular autonomic neuropathy, which affects people with type 2 diabetes. This condition involves damage to the nerves that control the heart and blood vessels, leading to issues with heart function. The study will explore how Finerenone, a type of medication known as a mineralocorticoid receptor antagonist, might help modify the disease in its early stages.

The purpose of the study is to investigate the potential benefits of Finerenone in improving nerve function, reducing fibrosis (a process where tissues become thickened and scarred), and decreasing inflammation in the body. Participants will be randomly assigned to receive either Finerenone or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This approach is known as a double-blind study, which helps ensure the results are unbiased.

The study will last for 78 weeks, during which participants will undergo various tests to assess nerve function, heart health, and levels of fibrosis and inflammation. These tests will help researchers understand how Finerenone affects the body and whether it can provide benefits for people with early-stage diabetic cardiovascular autonomic neuropathy. The findings from this study could lead to better treatment options for managing this condition in the future.

1 joining the study

Upon joining the study, the participant is required to provide informed consent, confirming understanding and agreement to participate.

Eligibility is confirmed based on criteria such as having type 2 diabetes, being 40 years or older, and having a specific E/I ratio.

2 randomization and blinding

Participants are randomly assigned to receive either the finerenone treatment or a placebo. This process is double-blinded, meaning neither the participant nor the researchers know which treatment is being administered.

3 treatment administration

The treatment involves taking finerenone in the form of a film-coated tablet. The medication is taken orally.

The duration of the treatment is 78 weeks, during which the participant will follow the prescribed dosage and frequency as instructed by the study protocol.

4 monitoring and assessments

Throughout the study, various assessments are conducted to monitor the effects of the treatment. These include cardiovascular reflex tests and heart rate variability indices.

Markers of fibrosis and inflammation are measured through blood tests and skin biopsies at specific intervals, such as weeks 0, 36, and 78.

5 completion of the study

At the end of the 78-week period, the participant completes the study. Final assessments are conducted to evaluate the outcomes of the treatment.

Who Can Join the Study?

  • Must have given informed consent, which means you understand the study and agree to participate.
  • Must have Type 2 diabetes, a condition where the body doesn’t use insulin properly, as defined by the World Health Organization (WHO).
  • Must be aged 40 or older at the time of joining the study.
  • Must have a pathological E/I ratio, which is a specific measure related to heart function. This involves taking the average of three measurements.

Who Cannot Join the Study?

  • Patients who do not have type 2 diabetes cannot participate. Type 2 diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
  • Patients who do not have early-stage CAN cannot participate. CAN stands for cardiovascular autonomic neuropathy, which is a type of nerve damage that affects the heart and blood vessels.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Steno Diabetes Center Copenhagen Herlev Denmark
Aalborg University Hospital Aalborg Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.01.2025

Trial locations

Investigated drugs:

Finerenone is a medication being studied for its potential to modify the progression of diabetic cardiovascular autonomic neuropathy (CAN) in people with type 2 diabetes. This trial aims to explore how finerenone affects nerve damage, fibrosis, inflammation, and heart function over a period of 78 weeks. Finerenone is a type of mineralocorticoid receptor antagonist, which means it works by blocking certain receptors in the body that can contribute to heart and kidney problems.

Investigated diseases:

Diabetic Cardiovascular Autonomic Neuropathy – This condition is a complication of diabetes that affects the autonomic nerves controlling the heart and blood vessels. It can lead to abnormalities in heart rate and blood pressure regulation. As the disease progresses, individuals may experience symptoms such as dizziness, fainting, or exercise intolerance due to impaired cardiovascular responses. Over time, the condition can result in a reduced ability to regulate heart rate and blood pressure during physical activities or stress. It is often associated with other diabetic complications and can significantly impact the quality of life. The progression of this neuropathy is typically gradual and may vary among individuals.

Trial ID:
2024-516597-30-00
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Venetoclax plus drug combination versus drug combination alone in children with relapsed acute myeloid leukemia

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark Finland France +8
  • A study to evaluate the efficacy and safety of depemokimab and salbutamol sulfate in patients with chronic obstructive pulmonary disease and type 2 inflammation.

    Recruiting

    3 1 1
    Belgium Bulgaria Denmark France Germany Greece +6