Finerenone for Heart Failure

(FINALITY-HF Trial)

Recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called finerenone for individuals with heart failure and reduced ejection fraction, a condition where the heart doesn't pump blood effectively. Researchers aim to determine if finerenone is safe and more effective than a placebo for those unable to use certain other heart medications. Ideal candidates have heart failure symptoms and cannot take steroidal treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that Finerenone is likely to be safe for humans?

Research shows that finerenone is usually well-tolerated by people with heart failure. Studies have found that it can lower the risk of heart failure complications and death from heart-related issues. Specifically, patients taking finerenone had fewer hospital visits for heart failure than those taking a placebo.

Regarding safety, while some side effects might occur, the treatment has been tested in many patients, providing a better understanding of its safety. Those with concerns should consult their doctor before deciding to join a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Finerenone is unique because it offers a novel approach to managing heart failure by specifically targeting the mineralocorticoid receptor. Unlike standard treatments like ACE inhibitors or beta-blockers, which primarily focus on reducing the workload on the heart and managing blood pressure, finerenone works at a cellular level to reduce inflammation and fibrosis in heart tissue. This targeted action could potentially lead to better heart health outcomes and fewer side effects, which is why researchers are excited about its potential.

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 lower the risk of death from heart problems and reduce hospital visits due to heart failure. In one study, it reduced these risks by 13% compared to a placebo. Another study found it decreased the chance of hospital visits related to heart failure by 17%. Finerenone has been especially helpful for patients whose hearts don't pump as well as they should. These findings suggest that finerenone could be a good option for heart failure patients, especially those unable to take some other heart medications. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 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 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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 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 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]

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]

Citations

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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, ...

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This Figure shows the effects of finerenone compared with placebo on clinical outcomes (primary composite outcome: total heart failure [HF] ...

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Finerenone in Heart Failure with Mildly Reduced or ...

Over a median follow-up of 32 months, 1083 primary-outcome events occurred in 624 of 3003 patients in the finerenone group, and 1283 primary- ...

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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 ...

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jamanetwork.com/journals/jamacardiology/fullarticle/2835441

Finerenone According to Frailty in Heart Failure

Compared with placebo, finerenone reduced the risk of worsening HF events and cardiovascular deaths and improved symptoms in patients with HFmrEF or HFpEF ...

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The FINEARTS-HF Trial | JACC: Heart Failure

Finerenone consistently reduced cardiovascular death and total HF events, irrespective of baseline NYHA functional class (RR: 0.86 [95% CI: 0.70-0.94] for NYHA ...