Finerenone for Heart Failure

(REDEFINE-HF Trial)

Recruiting at 3 trial locations

Overseen By Marc Bonaca

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Colorado Prevention Center

Must not be taking: MRAs, CYP3A4 inhibitors

Disqualifiers: Severe hyperkalemia, Low eGFR, 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: Unknown

Duration: Ongoing, up to ~30 months

5200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called finerenone to determine its effectiveness for people hospitalized with heart failure. The research examines whether finerenone is safe and effective compared to a placebo (a substance with no active treatment). The focus is on patients whose hearts are not pumping efficiently, particularly those with heart failure symptoms and specific heart imaging results. Ideal participants are currently or recently hospitalized for heart failure, showing signs like shortness of breath or fluid buildup. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if you are on a mineralocorticoid receptor antagonist or medications that strongly affect the CYP3A4 enzyme. The trial does not specify a washout period, but these medications are excluded.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that finerenone is generally safe for individuals with heart conditions. Studies have found it to be well-tolerated by patients with chronic heart failure and can improve heart health. A review of over 21,000 patients linked finerenone to fewer major heart-related events.

One study found that finerenone reduced serious heart problems by 14% in patients with diabetes and kidney disease, suggesting potential benefits for those with heart failure. Although no major safety concerns have emerged, like all medications, it can have side effects. Overall, the evidence supports finerenone's safety, particularly for those with similar health issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Finerenone is unique because it targets the mineralocorticoid receptor, which plays a key role in the progression of heart failure. Unlike standard treatments like ACE inhibitors or beta-blockers that focus on different pathways, finerenone directly addresses the hormonal imbalances contributing to heart issues. Researchers are excited because this targeted approach may offer improved outcomes for patients, especially those who haven't fully responded to existing therapies.

What evidence suggests that Finerenone might be an effective treatment for heart failure?

This trial will compare Finerenone with a placebo to evaluate its effectiveness for heart failure. Research has shown that Finerenone may help people with heart failure. A large study with over 21,000 participants found that Finerenone improved heart health, especially in those with diabetes and chronic kidney disease. Another study found that Finerenone reduced serious heart-related problems by 14%. However, some studies did not find a significant difference in heart failure outcomes compared to other treatments. Overall, Finerenone is a drug that helps reduce fluid buildup and stress on the heart, potentially benefiting heart failure patients. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure who are currently hospitalized or recently discharged. They must have a left ventricular ejection fraction of 40% or higher and show specific signs, symptoms, and elevated levels of certain heart-related biomarkers.

Inclusion Criteria

I was recently in the hospital for heart failure.

I was admitted to the hospital with heart failure symptoms.

Elevated NTproBNP or BNP levels are present if greater than 1000 pg/mL and 250 pg/mL for patients without AF, or 2000 pg/mL and 500 pg/mL for those with AF.

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 to assess efficacy and safety in heart failure patients

Ongoing, up to ~30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Finerenone
• Placebo

Trial Overview The study tests the effectiveness and safety of Finerenone compared to a placebo in patients with acute decompensated heart failure and mildly reduced or preserved heart function.

How Is the Trial Designed?

Group I: Finerenone Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Finerenone is already approved in United States, European Union for the following indications:

Approved in United States as Kerendia for:

• Chronic kidney disease associated with type 2 diabetes

Approved in European Union as Kerendia for:

• Chronic kidney disease associated with type 2 diabetes

Who Is Running the Clinical Trial?

Colorado Prevention Center

Lead Sponsor

Trials

13

Recruited

22,600+

Saint Luke's Hospital of Kansas City

Collaborator

Trials

4

Recruited

10,600+

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

St. Luke's Hospital, Kansas City, Missouri

Collaborator

Trials

9

Recruited

12,500+

Published Research Related to This Trial

Finerenone, a selective mineralocorticoid receptor antagonist, has been shown to effectively reduce urinary albumin levels in patients with type 2 diabetes and chronic kidney disease, with optimal effects observed at a dose of 20 mg.

The pharmacokinetics of finerenone were consistent across different populations, and both 10 mg and 20 mg doses were found to be safe, with no significant ethnic differences in drug response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Snelder, N., Heinig, R., Drenth, HJ., et al.[2021]

In a study involving 1066 patients with worsening heart failure and chronic kidney disease or diabetes, finerenone was well tolerated and led to a decrease of over 30% in NT-proBNP levels in a similar proportion of patients as the standard treatment, eplerenone.

The finerenone group, particularly at doses of 10-20 mg, showed a numerically lower occurrence of clinical events related to heart failure compared to eplerenone, suggesting potential benefits that warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Filippatos, G., Anker, SD., Böhm, M., et al.[2022]

Finerenone is a new non-steroidal mineralocorticoid receptor antagonist that has shown significant protective effects on the heart and kidneys in patients with chronic kidney disease and type 2 diabetes, as demonstrated in two major clinical trials (FIDELIO-DKD and FIGARO-DKD).

Preclinical studies indicate that finerenone may also improve various pathophysiological aspects of heart failure with preserved ejection fraction (HFpEF), suggesting it could be a promising new treatment option for this condition, which currently has limited pharmacological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The non-steroidal mineralocorticoid receptor antagonist finerenone and heart failure with preserved ejection fraction. Kintscher, U., Edelmann, F.[2023]

Finerenone, at a dose of 10 mg/day, is as effective as higher doses (20 to 50 mg/day) of traditional steroidal mineralocorticoid receptor antagonists in reducing NT-proBNP levels and aiding in ventricular remodeling in patients with chronic heart failure.

Finerenone demonstrated a significantly lower incidence of treatment-related adverse events and better safety profiles, particularly in patients with chronic kidney disease, compared to higher doses of steroidal MRAs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a novel non-steroidal mineralocorticoid receptor antagonist finerenone for the treatment of chronic heart failure: A systematic review and meta-analysis. Pei, H., Wang, W., Zhao, D., et al.[2021]

In a phase 2b study involving 72 Japanese patients with heart failure and chronic kidney disease or diabetes, finerenone showed varying efficacy in reducing NT-proBNP levels compared to eplerenone, with some finerenone doses achieving a 45.5% reduction.

Finerenone was well tolerated, with similar rates of hyperkalemia (high potassium levels) compared to eplerenone, suggesting it may be a safe option for further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study of Finerenone vs. Eplerenone in Japanese Patients With Worsening Chronic Heart Failure and Diabetes and/or Chronic Kidney Disease. Sato, N., Ajioka, M., Yamada, T., et al.[2021]

The ARTS-HF study is a phase 2b clinical trial involving 1060 patients with worsening chronic heart failure and reduced ejection fraction, aiming to evaluate the safety and efficacy of finerenone compared to eplerenone over 90 days.

Finerenone is being tested for its ability to significantly reduce levels of NT-proBNP, a marker of heart failure severity, which could indicate its potential effectiveness in improving heart failure outcomes in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease. Pitt, B., Anker, SD., Böhm, M., et al.[2021]

Finerenone (Kerendia) is approved for reducing the risk of serious kidney and cardiovascular issues in adults with chronic kidney disease linked to type 2 diabetes.

The medication specifically targets the decline in kidney function and helps prevent complications such as heart failure and heart attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Type 2 Diabetes Drug AIMS to Reduce Risk of Diminished Kidney Function and Cardiovascular Complications. Aschenbrenner, DS.[2023]

Finerenone is a first-in-class oral medication that selectively targets mineralocorticoid receptors, approved in the USA for reducing the risk of serious complications like kidney decline and heart issues in adults with chronic kidney disease related to type 2 diabetes.

It has shown efficacy in preventing sustained declines in kidney function and reducing cardiovascular risks, and is currently being studied in a phase III trial for heart failure with preserved ejection fraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finerenone: First Approval. Frampton, JE.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11799767/

Cardiovascular Efficacy and Safety of Finerenone: A Meta ... This meta‐analysis of 21 200 patients found that finerenone can improve cardiovascular outcomes in patients with diabetes, chronic kidney disease, or heart ...

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

Finerenone in heart failure and chronic kidney disease with ... A previous pooled analysis of the CKD with T2D trials showed that finerenone reduced major adverse cardiovascular events by 14% and a kidney ...

3. journals.lww.com journals.lww.com/md-journal/fulltext/2018/04200/the_use_of_a_novel_non_steroidal_mineralocorticoid.3.aspx

The use of a novel non-steroidal mineralocorticoid receptor ... The analysis of effective treatment in patient with CHF showed that adding finerenone treatment group show there is no statistically significant difference in ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2213177925004214

Efficacy and Safety of Finerenone in Heart Failure With ... Additional endpoints included cardiovascular death, HF hospitalization, new-onset atrial fibrillation, and all-cause death. Results. Among 18,991 pooled trial ...

5. frontiersin.org frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1575307/full

A systematic review and meta-analysis on the efficacy and ... Aims: Finerenone, a kind of mineralocorticoid receptor antagonist (MRA), may benefit heart failure (HF) patients as MRAs are established ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04908436

NCT04908436 | A Study to Learn How BAY94-8862 Moves ... A Study to Learn How BAY94-8862 Moves Into, Through and Out of the Body, How Safe it is and How it Affects the Body in Adult Participants With Reduced ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/215341Orig1s000IntegratedR.pdf

215341Orig1s000 - accessdata.fda.gov ... Safety and Tolerability of. Different Oral Doses of BAY 94-8862 in Subjects With Stable Chronic Heart Failure With. Left Ventricular Systolic ...