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Mineralocorticoid Receptor Antagonist

Finerenone for Heart Failure (FINEARTS-HF Trial)

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, months 6, 9 and 12
Awards & highlights

FINEARTS-HF Trial Summary

This trial will evaluate the effect of finerenone compared to placebo on reducing cardiovascular death and total heart failure events in patients with heart failure and ejection fraction greater than 40%.

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.Check my eligibility
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.See study design
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.

FINEARTS-HF Trial 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.
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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 have been on water pills for at least 30 days.
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My heart's pumping ability is at least 40%.
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My heart has structural issues as confirmed by recent scans.
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My heart failure markers are high and match the trial's requirements.

FINEARTS-HF Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart failure
Secondary outcome measures
Change in Total Symptom Score (TSS) from KCCQ.
Improvement in NYHA class from Baseline to Month 12
Time to death from any cause
+2 more

Side effects data

From 2020 Phase 3 trial • 5734 Patients • NCT02540993
15%
Hyperkalaemia
9%
Nasopharyngitis
7%
Anaemia
7%
Hypertension
6%
Glomerular filtration rate decreased
6%
Back pain
6%
Oedema peripheral
6%
Upper respiratory tract infection
6%
Urinary tract infection
6%
Diarrhoea
5%
Arthralgia
5%
Dizziness
5%
Hypoglycaemia
5%
Constipation
4%
Bronchitis
2%
Acute kidney injury
2%
Pneumonia
1%
Cellulitis
1%
Sepsis
1%
Hyperglycaemia
1%
Diabetic nephropathy
1%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Finerenone
Placebo

FINEARTS-HF 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
~15320

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,228 Previous Clinical Trials
25,319,146 Total Patients Enrolled
46 Trials studying Heart Failure
54,919 Patients Enrolled for Heart Failure

Media Library

Finerenone (Mineralocorticoid Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04435626 — Phase 3
Heart Failure Research Study Groups: Arm 2_Placebo, Arm 1_BAY94-8862
Heart Failure Clinical Trial 2023: Finerenone Highlights & Side Effects. Trial Name: NCT04435626 — Phase 3
Finerenone (Mineralocorticoid Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04435626 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are agreeing to participate in this experiment?

"In order to have a statistically significant sample size, 6000 patients that fit the specified inclusion criteria are required to participate in this study. Patients can choose to participate at Louisiana Heart Center Research - Slidell in Slidell, Louisiana or Centre Hospitalier de l'Université de Montréal-CHUM in Montreal, Quebec."

Answered by AI

Are we looking for more participants for this research?

"Yes, that is accurate. The clinical trial is still recruiting patients, as of today. The study was created on September 14th 2020 and was last updated 100 days ago. The trial has 100 sites and is looking for 6000 participants."

Answered by AI

When will Finerenone (BAY94-8862) be available to the public?

"There is some evidence, from both efficacy and safety trials, that suggests that Finerenone (BAY94-8862) is a safe medication."

Answered by AI

What has Finerenone (BAY94-8862) been known to help with in the past?

"cardiovascular mortality is most commonly treated with Finerenone (BAY94-8862). Finerenone (BAY94-8862) can also be effective at treating other conditions including heart failure, type 2 diabetes mellitus, and myocardial infarction."

Answered by AI

Is this the first time that Finerenone (BAY94-8862) has been trialed?

"A.O.U. Policlinico Federico II Napoli first studied Finerenone (BAY94-8862) in 2020. Out of the 18,246 total completed trials, 2 are ongoing with a large portion based out of Slidell, Louisiana."

Answered by AI

Are there any other ongoing studies like this one?

"Bayer first sponsored a clinical trial for Finerenone in 2020. Since then, there have been 2 active studies involving the drug across 448 cities and 39 countries."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Baptist Heart -Cardiology
ClinRx Research, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Hoping to find more affordable medication.
PatientReceived 1 prior treatment
~140 spots leftby May 2024