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Tests treatment safety and results for Heart Failure
Official title A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
ClinicalTrials.gov ID: NCT06008197
What this study is testing
What is Finerenone?
Finerenone is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for heart failure.
Also referred to as Kerendia, Firialta.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide written informed consent
- Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
- Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
- Heart failure signs and symptoms at the time of hospital admission
- Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
You likely can't join if
- Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
- Documented prior history of severe hyperkalemia in the setting of MRA use
- Estimated glomerular filtration rate (eGFR) \ 5.0 mmol/L at screening
- Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac...
- Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
- Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with...
See the full eligibility criteria
- Provide written informed consent
- Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
- Current hospitalization or recently discharged (during or within 30 days of discharge) with the primary diagnosis of heart failure
- Heart failure signs and symptoms at the time of hospital admission
- Imaging evidence of mildly reduced or preserved left ventricular ejection fraction (EF) (40% or higher)
- Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL...
- Current or planned long-term treatment with a mineralocorticoid receptor antagonist (MRA)
- Documented prior history of severe hyperkalemia in the setting of MRA use
- Estimated glomerular filtration rate (eGFR) \ 5.0 mmol/L at screening
- Acute myocardial infarction due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
- Hemodynamically significant (severe) uncorrected primary cardiac valvular disease
- Cardiomyopathy due to known acute inflammatory heart, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex...
- Probable alternative cause of participant's heart failure symptoms
- Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
- Known hypersensitivity to the IP (active substance or excipients)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Huntsville, Alabama, United States
- Glendale, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Chula Vista, California, United States
- Huntington Beach, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Tarzana, California, United States
- Van Nuys, California, United States
- West Hills, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Bradenton, Florida, United States
- Brooksville, Florida, United States
- Fort Lauderdale, Florida, United States
- Fort Myers, Florida, United States
+ 237 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Fairhope, Alabama, United States; Huntsville, Alabama, United States; Glendale, Arizona, United States; Phoenix, Arizona, United States; Scottsdale, Arizona, United States and 251 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.