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 and water retention, leading to increased blood pressure and fluid overload. This is crucial for heart failure patients as it helps reduce fluid buildup and strain on the heart. Other common treatments include ACE inhibitors, which relax blood vessels and lower blood pressure; beta-blockers, which reduce heart rate and the heart's workload; and diuretics, which help eliminate excess fluid. Together, these treatments improve symptoms, reduce hospitalizations, and enhance the quality of life for heart failure patients.

What side effects are associated with this type of intervention?

Mineralocorticoid Receptor Antagonists (MRAs) such as Finerenone and Spironolactone are commonly used in heart failure treatment. Known side effects of MRAs include hyperkalemia (elevated potassium levels), renal impairment, and gynecomastia (breast enlargement in men). Other common treatments for heart failure include ACE inhibitors, which can cause cough, hyperkalemia, and renal dysfunction; beta-blockers, which may lead to bradycardia (slow heart rate), fatigue, and dizziness; and diuretics, which can result in electrolyte imbalances, dehydration, and hypotension (low blood pressure).

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. Spironolactone is often used in patients with severe heart failure to reduce morbidity and mortality, while eplerenone is indicated for patients with heart failure post-myocardial infarction. These drugs work by antagonizing the effects of aldosterone, thereby reducing fluid retention and improving heart function. Finerenone, another MRA, is currently being studied for its efficacy and safety in patients with acute decompensated heart failure and mildly reduced or preserved left ventricular ejection fraction.

What other types of research exist?

Promising novel alternatives to Finerenone for heart failure patients include SGLT2 inhibitors (e.g., dapagliflozin and empagliflozin), which have shown significant benefits in reducing heart failure hospitalizations and cardiovascular mortality. Additionally, vericiguat, a soluble guanylate cyclase stimulator, has demonstrated efficacy in reducing heart failure-related events in patients with worsening heart failure. These therapies represent significant advancements in heart failure management and are expected to be key treatment options in 2024.

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Mineralocorticoid Receptor Antagonist

Finerenone for Heart Failure (REDEFINE-HF Trial)

Phase 3

Recruiting

Research Sponsored by Colorado Prevention Center

Eligibility Criteria Checklist

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

Must have

Current hospitalization or recently discharged with the primary diagnosis of heart failure

Heart failure signs and symptoms at the time of hospital admission

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ongoing, up to ~30 months

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of Finerenone may include high potassium levels, changes in kidney function, low blood pressure, dizziness, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I was recently in the hospital for heart failure.

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I was admitted to the hospital with heart failure symptoms.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ongoing, up to ~30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ongoing, up to ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing, up to ~30 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite total of HF events and cardiovascular (CV) death.

Number of adverse events leading to discontinuation of study drug.

Number of serious adverse events.

Secondary study objectives

Time to CV death.

Time to death from any cause.

Time to first occurrence of the composite of CV death or HF event.

+1 more

Other study objectives

Number of patients requiring initiation of dialysis or renal transplant.

Number of patients with sustained decrease in eGFR ≥40% relative to baseline.

Number of patients with sustained eGFR <15 ml/min/1.73 m^2.

+2 more

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: FinerenoneExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Finerenone

2022

N/A

~250

0 / 3Eligibility 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 and water retention, leading to increased blood pressure and fluid overload. This is crucial for heart failure patients as it helps reduce fluid buildup and strain on the heart. Other common treatments include ACE inhibitors, which relax blood vessels and lower blood pressure; beta-blockers, which reduce heart rate and the heart's workload; and diuretics, which help eliminate excess fluid. Together, these treatments improve symptoms, reduce hospitalizations, and enhance the quality of life for heart failure patients.