Finerenone for Heart Failure

(FINALITY-HF Trial)

Recruiting at 7 trial locations

Overseen By Marc Bonaca

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Colorado Prevention Center

Must not be taking: Non-steroidal MRA, CYP3A4 inhibitors

Disqualifiers: Low eGFR, Heart transplant, 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: 30 months

2600 Participants Needed

Trial Summary

What is the purpose of this trial?

Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).

Will I have to stop taking my current medications?

The trial requires that you do not take non-steroidal MRA medications and certain other drugs that affect liver enzymes (CYP3A4 inhibitors or inducers). If you are on these medications, you may need to stop them to participate.

What data supports the effectiveness of the drug finerenone for heart failure?

Finerenone has shown potential benefits for heart failure with preserved ejection fraction (HFpEF) in preclinical models and subgroup analyses of trials in patients with chronic kidney disease and type 2 diabetes. Additionally, it has been studied for heart failure with reduced ejection fraction (HFrEF), showing some promise compared to other treatments like eplerenone. ^{1 2 3 4 5}

Is Finerenone generally safe for human use?

The research articles provided do not contain specific safety data for Finerenone. However, they discuss general cardiac risks associated with various drugs, emphasizing the importance of monitoring for heart-related side effects. ^{6 7 8 9 10}

How is the drug finerenone unique for treating heart failure?

Finerenone is unique because it is a non-steroidal mineralocorticoid receptor antagonist (a type of drug that blocks certain hormones) with high selectivity and a short half-life, which means it works quickly and specifically. It has shown potential benefits in heart failure with preserved ejection fraction, a condition with limited treatment options, by improving various heart-related functions. ^{2 3 4 11 12}

Eligibility Criteria

This trial is for adults with heart failure who can't take standard steroidal mineralocorticoid receptor antagonists due to intolerance or ineligibility. Participants must have symptoms of reduced heart function, agree to use contraception if applicable, and provide consent.

Inclusion Criteria

Female participants must provide a negative pregnancy test and demonstrate willingness to use effective birth control during the trial.

You must give explicit consent, either verbally or in writing, personally or through a recognized third party.

I have heart failure with reduced ejection fraction and symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive finerenone or placebo to evaluate efficacy and safety in heart failure patients with reduced ejection fraction

30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Finerenone

Trial Overview The study tests Finerenone against a placebo in patients with symptomatic heart failure and reduced ejection fraction (HFrEF). It aims to assess the drug's effectiveness and safety for those who cannot use typical heart failure medication.

Participant Groups

Group I: Finerenone Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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+

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Industry Sponsor

Trials

28

Recruited

126,000+

Findings from Research

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]

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]

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]

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]

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]

A comprehensive database of 396,985 drug-related cardiac adverse effects (AEs) linked to 1,632 approved drugs was created, revealing significant clusters of AEs affecting heart function, such as arrhythmias and heart failure.

The study identified that cardiac AEs are highly correlated with drugs targeting cardiovascular functions and specific mechanisms of action, including interactions with various receptors like alpha- and beta-adrenergic receptors, which may help predict and understand these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of drug-related cardiac adverse effects in humans--A: creation of a database of effects and identification of factors affecting their occurrence. Matthews, EJ., Frid, AA.[2013]

Between 2010 and 2016, 164 safety advisories regarding cardiac-related adverse events were issued by regulators in Australia, Canada, the UK, and the US, highlighting the prevalence of risks associated with 61 different drugs, primarily involving cardiac arrhythmias and coronary artery disorders.

While monitoring patients was the most common recommendation in these advisories, only 41.2% provided detailed guidance on how to conduct this monitoring, indicating a need for more consistent and comprehensive information for healthcare professionals and consumers regarding rare but serious medication harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. Hooimeyer, A., Bhasale, A., Perry, L., et al.[2023]

The identification of driver mutations in tumors has led to the rise of personalized medicine in cancer treatment, allowing for targeted therapies like the BRAF inhibitor vemurafenib, which was approved for metastatic melanoma in 2012.

While targeted treatments are generally well-tolerated, they come with a new range of side effects that healthcare providers must understand and manage to ensure optimal patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Side effects of systemic oncological therapies in dermatology. Zimmer, L., Vaubel, J., Livingstone, E., et al.[2012]

The study developed advanced in silico models that effectively identify drug-induced cardiovascular complications, achieving a success rate of 87% when validated against 63 anticancer agents.

These models integrate multiple machine-learning algorithms to enhance the prediction of cardiovascular risks, making them useful for both early drug discovery and ongoing postmarketing surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In Silico Pharmacoepidemiologic Evaluation of Drug-Induced Cardiovascular Complications Using Combined Classifiers. Cai, C., Fang, J., Guo, P., et al.[2023]

A review of 11,721 serious adverse event reports from patients treated with BRAF and MEK inhibitors revealed that different combinations have unique safety profiles, with V+C showing a high incidence of skin toxicities like Stevens-Johnson syndrome.

The combination E+B was notably associated with an increased risk of peripheral neuropathies and renal disorders, as well as a significant rise in reports of Guillain-Barré syndrome, indicating that while these treatments improve survival in melanoma, they also carry serious risks that need careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of BRAF+MEK Inhibitor Combinations: Severe Adverse Event Evaluation. Meirson, T., Asher, N., Bomze, D., et al.[2020]

Finerenone, a new non-steroidal mineralocorticoid receptor antagonist, has been shown to significantly reduce cardiovascular events, including heart failure hospitalizations, in patients with chronic kidney disease (CKD) and diabetes, based on results from the phase III FIDELIO-DKD and FIGARO-DKD trials.

The drug is specifically indicated for improving both renal and cardiovascular outcomes in CKD patients with diabetes, and future studies will explore its effects in non-diabetic CKD and heart failure with preserved ejection fraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of the Non-Steroidal Mineralocorticoid Antagonist Finerenone in Cardiorenal Management. Beavers, CJ.[2023]

Finerenone is a new selective nonsteroidal mineralocorticoid receptor antagonist that shows promise in providing cardiorenal protection with lower doses needed compared to existing treatments like spironolactone and eplerenone.

In phase II studies, finerenone demonstrated effectiveness and safety in patients with heart failure, type-2 diabetes, and chronic kidney disease, significantly reducing albuminuria while maintaining a low risk of hyperkalemia, but further large-scale phase III trials are necessary to confirm its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renin-angiotensin system blockade: Finerenone. Ruilope, LM., Tamargo, J.[2021]

References

1. United States 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

The non-steroidal mineralocorticoid receptor antagonist finerenone and heart failure with preserved ejection fraction. [2023]

3. England 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. [2021]

4. Japan 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. [2021]

5. England 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Prediction of drug-related cardiac adverse effects in humans--A: creation of a database of effects and identification of factors affecting their occurrence. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Regulatory post-market drug safety advisories on cardiac harm: A comparison of four national regulatory agencies. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Side effects of systemic oncological therapies in dermatology. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

In Silico Pharmacoepidemiologic Evaluation of Drug-Induced Cardiovascular Complications Using Combined Classifiers. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of BRAF+MEK Inhibitor Combinations: Severe Adverse Event Evaluation. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

The Role of the Non-Steroidal Mineralocorticoid Antagonist Finerenone in Cardiorenal Management. [2023]

12. France pubmed.ncbi.nlm.nih.gov

Renin-angiotensin system blockade: Finerenone. [2021]