Finerenone for Heart Failure

(REDEFINE-HF Trial)

Recruiting at 3 trial locations

Overseen By Marc Bonaca

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Colorado Prevention Center

Must not be taking: MRAs, CYP3A4 inhibitors

Disqualifiers: Severe hyperkalemia, Low eGFR, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing finerenone, a medication, to see if it can help people with a specific type of heart failure. It focuses on patients who are hospitalized and have mildly reduced or preserved heart function. The medication works by blocking harmful signals that can worsen heart failure.

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.

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

Finerenone has been shown to help reduce the risk of serious kidney and heart complications in adults with chronic kidney disease and type 2 diabetes, and it is being studied for its potential benefits in heart failure. Some studies suggest it may be effective for heart failure with reduced ejection fraction, but results have been mixed. ^{1 2 3 4 5}

Is finerenone safe for humans?

Finerenone has been studied for safety in people with heart failure and chronic kidney disease, and it is approved in the USA to reduce risks of serious kidney and heart problems in adults with chronic kidney disease and type 2 diabetes. However, some studies have reported conflicting results about its safety, so it's important to discuss potential risks with a healthcare provider. ^{1 2 3 4 6}

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, making it different from other treatments like spironolactone or eplerenone. It is also the first of its kind to be approved for reducing serious kidney and heart complications in patients with chronic kidney disease and type 2 diabetes, and it shows promise for heart failure with preserved ejection fraction, a condition with limited treatment options. ^{1 2 3 7 8}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Finerenone (Mineralocorticoid Receptor Antagonist)
• Placebo (Drug)

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.

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+

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 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]

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]

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 (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, 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]

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]

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. New Zealand pubmed.ncbi.nlm.nih.gov

Finerenone: First Approval. [2022]

3. 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]

4. 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]

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

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

7. Switzerland 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. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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