What side effects are associated with this type of intervention?

Common treatments for heart failure, particularly Mineralocorticoid Receptor Antagonists (MRAs) like Finerenone, often include side effects such as hyperkalemia (elevated potassium levels), which can lead to serious cardiac issues. Other side effects may include renal impairment, hypotension (low blood pressure), and dizziness. In clinical trials, Finerenone has shown a low incidence of hyperkalemia-related treatment discontinuation. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Mineralocorticoid Receptor Antagonists (MRAs) like spironolactone and eplerenone have been previously approved by the FDA for the treatment of heart failure. These drugs work by blocking the effects of aldosterone, thereby reducing fluid retention and improving heart function. Spironolactone is often used in patients with severe heart failure, while eplerenone is typically prescribed for patients with heart failure following a myocardial infarction. Both drugs have shown benefits in reducing mortality and hospitalizations related to heart failure.

What other types of research exist?

Promising novel alternatives to Finerenone for heart failure patients include SGLT2 inhibitors (such as dapagliflozin and empagliflozin), which have shown significant benefits in heart failure patients with reduced and preserved ejection fraction. Additionally, ARNI (angiotensin receptor-neprilysin inhibitors) like sacubitril/valsartan continue to be a strong option. Vericiguat, a soluble guanylate cyclase stimulator, is another novel agent that has shown promise in reducing heart failure-related hospitalizations and cardiovascular death.

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Mineralocorticoid Receptor Antagonist

Finerenone for Heart Failure (FINEARTS-HF Trial)

Q: What is the mechanism of action of this treatment?

Mineralocorticoid receptor antagonists (MRAs) like Finerenone work by blocking the effects of aldosterone, a hormone that can cause sodium retention, potassium loss, and fibrosis in the heart and blood vessels. This helps reduce fluid overload, lower blood pressure, and prevent cardiac remodeling, which is crucial for managing heart failure. Other common treatments include ACE inhibitors, which reduce the production of angiotensin II, leading to vasodilation and decreased blood pressure; beta-blockers, which slow the heart rate and reduce myocardial oxygen demand; and SGLT2 inhibitors, which help reduce glucose reabsorption in the kidneys and have been shown to improve heart failure outcomes. These treatments collectively help to manage symptoms, improve quality of life, and reduce mortality in heart failure patients.

Phase 3

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant (male or female) must be aged 40 years and older.

Diagnosis of heart failure with New York Heart Association(NYHA) class II-IV, ambulatory or hospitalized primarily for heart failure.

Must not have

Estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m² at either screening or randomization visit.

Percutaneous coronary intervention in the 30 days prior to randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, months 6, 9 and 12

Awards & highlights

Pivotal Trial

Summary

This trial is testing finerenone, a pill, to see if it can reduce deaths and hospital visits in patients aged 40+ with a specific type of heart failure. The medication works by blocking harmful signals that can damage the heart and kidneys.

Who is the study for?

This trial is for adults aged 40+ with heart failure and a left ventricular ejection fraction of 40% or higher. They must have had recent heart failure events or been on diuretics for at least 30 days. Women of childbearing age need a negative pregnancy test and must use contraception.

What is being tested?

Researchers are testing if finerenone, taken as an oral tablet once daily, can reduce cardiovascular deaths and heart failure events compared to a placebo. The study will involve up to 6000 patients over approximately 43 months.

What are the potential side effects?

While the specific side effects of finerenone aren't listed here, common ones may include changes in kidney function, blood potassium levels, blood pressure variations, and potential risks associated with taking oral medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I have heart failure and it affects my daily activities or I've been hospitalized for it.

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I am 40 years old or older.

Select...

I have heart failure and it affects my daily activities or I've been hospitalized for it.

Select...

My heart has structural issues as confirmed by recent scans.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is very low.

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I had a procedure to open blocked arteries in my heart within the last 30 days.

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My blood pressure is high despite medication, measured twice.

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I am not taking strong medications that affect liver enzymes and can't stop them for the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, months 6, 9 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, months 6, 9 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, months 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heart failure

Secondary study objectives

Change in Total Symptom Score (TSS) from KCCQ.

Time to first occurrence of composite renal endpoint

Side effects data

From 2020 Phase 3 trial • 5734 Patients • NCT02540993

15%

Hyperkalaemia

Nasopharyngitis

Anaemia

Hypertension

Oedema peripheral

Upper respiratory tract infection

Diarrhoea

Urinary tract infection

Glomerular filtration rate decreased

Back pain

Constipation

Hypoglycaemia

Arthralgia

Dizziness

Bronchitis

Pneumonia

Acute kidney injury

Diabetic nephropathy

Hyperglycaemia

Cellulitis

Sepsis

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Finerenone

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1_BAY94-8862Experimental Treatment1 Intervention

Adult patients receive BAY94-8862

Group II: Arm 2_PlaceboPlacebo Group1 Intervention

Adult patients receive placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Finerenone (BAY94-8862)

2013

Completed Phase 3

~21330

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mineralocorticoid receptor antagonists (MRAs) like Finerenone work by blocking the effects of aldosterone, a hormone that can cause sodium retention, potassium loss, and fibrosis in the heart and blood vessels. This helps reduce fluid overload, lower blood pressure, and prevent cardiac remodeling, which is crucial for managing heart failure. Other common treatments include ACE inhibitors, which reduce the production of angiotensin II, leading to vasodilation and decreased blood pressure; beta-blockers, which slow the heart rate and reduce myocardial oxygen demand; and SGLT2 inhibitors, which help reduce glucose reabsorption in the kidneys and have been shown to improve heart failure outcomes. These treatments collectively help to manage symptoms, improve quality of life, and reduce mortality in heart failure patients.