Finerenone for Heart Failure

(FINE-MECH Trial)

Not yet recruiting at 2 trial locations

Overseen By Subodh Verma, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Subodh Verma

Must not be taking: MRAs, CYP3A4 inhibitors

Disqualifiers: Type 1 diabetes, Severe obesity, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 12 months

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. ^{1 2 3 4}

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. ^{5 6 7 8 9}

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

Evidence of left ventricular (LV) hypertrophy ≤12 months prior to or at screening showing specific criteria related to IVS thickness, PW thickness, LVMi by echocardiography, and LVMi by cMRI

I have at least one risk factor like heart failure, diabetes, or specific kidney function levels.

I am 18 or older and can sign a consent form.

Exclusion Criteria

I have a heart condition like slow heartbeat, heart block, weak heart muscle, previous heart attack, or valve disease.

I do not have any health conditions that would prevent me from joining the trial.

Allergy to finerenone or gadolinium

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive finerenone or placebo once daily for 12 months

12 months

6-7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Finerenone Active Control 1 Intervention

Active treatment group

Group II: Placebo Placebo Group 1 Intervention

Control treatment group

Who Is Running the Clinical Trial?

Subodh Verma

Lead Sponsor

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

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

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39225278/

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 ...

2. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2837458

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) ...

3. jacc.org jacc.org/doi/full/10.1016/S0735-1097(25)01678-X

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 ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.072011

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, ...

5. nature.com nature.com/articles/s41591-024-03264-4

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 ...

6. jacc.org jacc.org/doi/10.1016/j.jchf.2025.102778

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, ...

7. ahajournals.org ahajournals.org/doi/10.1161/circ.152.suppl_3.4369336

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) ...

8. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2407107

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 ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40505158/

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 ...