Finerenone for Heart Failure

(FIORE Trial)

Not yet recruiting at 138 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Bayer

Must not be taking: Mineralocorticoid antagonists

Disqualifiers: Severe renal dysfunction, Arrhythmias, 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: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find a better treatment for children with heart failure and left ventricular systolic dysfunction (LVSD). Researchers are testing finerenone, a medication that may improve heart function by reducing inflammation and scarring. The trial will compare the effects of finerenone to a placebo, a non-active treatment. Children diagnosed with heart failure and LVSD, experiencing symptoms like shortness of breath or fatigue, might be suitable for this study. Participants will continue their usual heart treatments during the trial. 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?

The trial does not require you to stop taking your current heart failure medications. Participants will continue their standard heart failure treatments during the study.

Is there any evidence suggesting that finerenone is likely to be safe for children with heart failure and LVSD?

Earlier research has shown that finerenone positively affects heart failure. It reduced the risk of hospitalization for heart failure or death from heart issues compared to a placebo, suggesting it might improve heart function.

However, finerenone can sometimes impair kidney function, so doctors closely monitor this side effect in any trial.

The FDA has approved finerenone for treating some heart failure patients, which provides some confidence in its safety. However, this study marks the first time finerenone is being tested specifically in children with heart failure and LVSD. While earlier findings are promising, the safety for children is still under careful study. ^{1 2 3 4 5}

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

Finerenone is unique because it offers a new approach to treating heart failure by specifically targeting mineralocorticoid receptors, which play a role in the body's fluid and electrolyte balance. Unlike other treatments like ACE inhibitors or beta-blockers, finerenone is a non-steroidal agent, potentially reducing the risk of certain side effects associated with steroid-based treatments. Researchers are excited about finerenone because it has shown promise in effectively managing symptoms of heart failure while potentially offering a better safety profile.

What evidence suggests that finerenone might be an effective treatment for heart failure in children?

Research has shown that finerenone, which participants in this trial may receive, can help reduce hospital visits for heart failure. In studies with adults, finerenone lowered the risk of hospitalization for heart failure by about 17% compared to a placebo. It also reduced deaths related to heart problems and hospital visits for heart failure. Finerenone blocks a protein that causes inflammation and scarring, aiding the heart in pumping blood more effectively. While this is the first study in children, these results offer hope for its effectiveness in treating heart failure with left ventricular systolic dysfunction (LVSD). ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 6 months to less than 18 years with heart failure and left ventricular systolic dysfunction (LVSD). They must be experiencing symptoms like shortness of breath or fatigue, and should not have any medical conditions that could interfere with the study.

Inclusion Criteria

My body weight is at least 4.0 kg.

I am between 6 months and 18 years old.

My heart's left ventricle is not pumping well, with an ejection fraction of 50% or less.

Exclusion Criteria

Serum potassium: > 5.0 mmol/L for children ≥ 2 years of age at either screening or randomization visit, > 5.3 mmol/L for children ≥ 6 months to < 2 years of age at either screening or randomization visit (if estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73m², threshold of > 5.0 mmol/L will be used).

My kidney function is severely impaired.

I haven't taken drugs like spironolactone or eplerenone in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either finerenone or placebo for 3 months, with standard heart failure treatments

12 weeks

At least 3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Open-label extension (optional)

Eligible participants may opt into a 9-month extension study receiving finerenone

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Finerenone

Trial Overview The trial tests finerenone, a medication thought to improve heart function by reducing inflammation and scarring, against a placebo. Children will continue their standard treatments while participating in this three-month study, which includes regular monitoring through blood tests and heart exams.

How Is the Trial Designed?

Group I: Finerenone (Kerendia, BAY94-8862) Experimental Treatment 1 Intervention

Participants will receive finerenone treatment.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo to finerenone.

Who Is Running the Clinical Trial?

Bayer

Lead 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/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 ...

2. bayer.com bayer.com/en/us/news-stories/new-data-for-kerendia

Bayer to Highlight New Data for KERENDIA® (finerenone) ... Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure.

3. 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 ...

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2826717

Finerenone, Serum Potassium, and Clinical Outcomes in ... Among 6001 patients in a clinical trial, finerenone increased potassium levels greater than 5.5 mmol/L and decreased potassium levels less than 3.5 mmol/L.

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

Efficacy and Safety of Finerenone in Heart Failure With ... Over a median follow-up of 2.5 years, finerenone reduced cardiovascular death or heart failure hospitalization compared with placebo (HR: 0.87 [95% CI: 0.78- ...

6. 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) ...

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

Cardiovascular Efficacy and Safety of Finerenone: A Meta ... The pooled analysis demonstrated a significant reduction in all‐cause death (RR 0.92, 95% CI: 0.85–0.99), major adverse CV events (RR 0.85, 95% ...

8. bayer2019tf.q4web.com bayer2019tf.q4web.com/news/news-details/2025/U-S--FDA-Approves-KERENDIA-finerenone-to-Treat-Patients-With-Heart-Failure-With-Left-Ventricular-Ejection-Fraction-40-Following-Priority-Review/default.aspx

U.S. FDA Approves KERENDIA® (finerenone) to Treat ... “The FDA's approval of finerenone expands treatment options for patients with heart failure with a left ventricular ejection fraction of ≥40% – ...