Finerenone for Heart Failure
(FINE-MECH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the drug finerenone can improve heart function in people with risk factors for heart and kidney disease. Researchers aim to determine if adding finerenone to regular heart failure treatments can beneficially alter the heart's structure and function, particularly in those with an enlarged left side of the heart. Participants will receive either finerenone or a placebo and undergo heart scans at the start and end of the study. The trial seeks individuals with risk factors such as a history of heart failure with preserved function, type 2 diabetes, or kidney issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in heart treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs that affect liver enzymes (CYP3A4 inhibitors or inducers) during the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that finerenone is likely to be safe for humans?
Research shows that finerenone is generally safe for people with heart conditions. Past studies found that finerenone reduced the risk of hospitalization for heart failure or death from heart-related issues compared to a placebo. However, some participants experienced higher potassium levels in their blood, known as hyperkalemia. Doctors will monitor this closely during the trial. Overall, finerenone appears safe, with side effects manageable through regular check-ups.1234
Why do researchers think this study treatment might be promising for heart failure?
Most treatments for heart failure focus on reducing symptoms and slowing disease progression, often using medications like ACE inhibitors, beta-blockers, or diuretics. But finerenone works differently, targeting mineralocorticoid receptors to reduce inflammation and fibrosis in the heart and kidneys. This unique mechanism of action not only addresses symptoms but also aims to protect organ function, which could be a game-changer for patients. Researchers are excited because finerenone has the potential to improve outcomes by tackling the underlying causes of heart failure, rather than just managing its symptoms.
What evidence suggests that finerenone might be an effective treatment for heart failure?
Research shows that finerenone, which participants in this trial may receive, can help people with heart failure. Studies have found that it lowers the risk of dying from heart problems and reduces hospital visits. Specifically, for those with both heart failure and chronic kidney disease, finerenone decreased the chance of hospitalization for heart issues by 17%. Other research indicates that finerenone also helps people with normal heart function live longer. These findings suggest that finerenone could improve heart health for those at risk of heart and kidney problems.56789
Who Is on the Research Team?
Subodh Verma, MD, PhD
Principal Investigator
North York Diagnostic and Cardiac Centre
Are You a Good Fit for This Trial?
This trial is for people at risk of heart and kidney disease with an enlarged left side of the heart. They should be able to take a daily tablet for 12 months and attend clinic visits. Specific inclusion or exclusion criteria are not provided, but typically participants must meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive finerenone or placebo once daily for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Finerenone
Trial Overview
The study tests if finerenone improves heart function when added to standard heart failure treatments compared to a placebo. Participants will receive either finerenone or placebo daily for a year, with cardiac MRI scans at the start and end.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Active treatment group
Control treatment group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Subodh Verma
Lead Sponsor
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD
Citations
Finerenone in Heart Failure with Mildly Reduced or ...
Results: Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 of 3003 patients in the finerenone group, and 1283 ...
Efficacy and Tolerability of Finerenone According to the ...
The incidence rate of the primary outcome in this group was 10.2 (95% CI, 7.6-13.9) per 100 person-years (eTable 2 and eFigure 2 in Supplement 3) ...
IMPACT OF FINERENONE ON CARDIOVASCULAR ...
Finerenone use in HFpEF patients was associated with improved survival and reduced rates of MACE (composite of AMI, AHF, and stroke). These results support ...
A Prespecified Analysis of the FINEARTS-HF Trial
In patients with HF with mildly reduced or preserved ejection fraction, finerenone reduced the risk of cardiovascular death and worsening HF events, ...
Finerenone in heart failure and chronic kidney disease with ...
Finerenone further reduced the risk of hospitalization from heart failure (HR: 0.83; 95% CI: 0.75–0.92; P < 0.001) and the composite kidney ...
Finerenone and Cardiovascular Outcomes According to ...
The corresponding absolute event rates were 9.2 vs 12.5, 16.5 vs 19.9, and 28.0 vs 28.0 per 100 patient-years for finerenone vs placebo, ...
Abstract 4369336: Effects of Finerenone on Heart Failure ...
Compared with placebo, finerenone reduced the risk of time-to-first HF hospitalization or cardiovascular death (HR, 0.83; 95% CI, 0.74-0.93) ...
Finerenone in Heart Failure with Mildly Reduced or ...
Finerenone was associated with an increased risk of hyperkalemia and a reduced risk of hypokalemia. Conclusions. In patients with heart failure ...
Efficacy and Safety of Finerenone in Heart Failure With ...
Finerenone additionally appeared to reduce heart failure hospitalization (HR: 0.84 [95% CI: 0.74-0.94]; P = 0.003) and new-onset atrial ...
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