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Finerenone for Heart Failure (FINEARTS-HF Trial)
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%.
FINEARTS-HF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFINEARTS-HF Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 5734 Patients • NCT02540993FINEARTS-HF Trial Design
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- I have not been hospitalized or needed urgent care for heart failure in the last 90 days.I have had heart bypass surgery in the last 3 months.I had a procedure to open blocked arteries in my heart within the last 30 days.My heart's pumping ability is at least 40%.I am 40 years old or older.I haven't had a heart attack or any heart issues affecting its pumping ability in the last 3 months.If your breathing problems are likely caused by lung disease, anemia, or being very overweight, you cannot join the study. Specifically, if you need home oxygen for severe lung disease, have certain types of high blood pressure in the lungs, have very low hemoglobin levels, have serious heart valve problems, or are extremely overweight, you cannot join the study.My heart failure markers are high and match the trial's requirements.I have been on water pills for at least 30 days.Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and baseline and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.I am 40 years old or older.I have heart failure and it affects my daily activities or I've been hospitalized for it.My kidney function is very low.I have not had a recent heart inflammation.Your blood potassium level is higher than 5.0 mmol/L.I am not taking strong medications that affect liver enzymes and can't stop them for the trial.I have not had a stroke or mini-stroke in the last 3 months.My blood pressure is high despite medication, measured twice.I have heart failure and it affects my daily activities or I've been hospitalized for it.I have been on water pills for at least 30 days.My heart's pumping ability is at least 40%.My heart has structural issues as confirmed by recent scans.
- Group 1: Arm 2_Placebo
- Group 2: Arm 1_BAY94-8862
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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