A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Recruiting · NCT06008197 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
FinerenonePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 for patients with AF
Exclusion criteria
- 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) \<25 mL/min/1.73m² or potassium \>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 congenital heart disease, or known pericardial constriction
- 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)
Where it is running
60 locations listed across 32 US states.
- Birmingham, AL Investigative Site 10012 - Birmingham, Alabama, United States
- Fairhope, AL Investigative Site 10004 - Fairhope, Alabama, United States
- Huntsville, AL Investigative Site 10026 - Huntsville, Alabama, United States
- Glendale, AZ Investigative Site 10096 - Glendale, Arizona, United States
- Phoenix, AZ Investigative Site 10115 - Phoenix, Arizona, United States
- Scottsdale, AZ Investigative Site 10003 - Scottsdale, Arizona, United States
- Chula Vista, CA Investigative Site 10111 - Chula Vista, California, United States
- Huntington Beach, CA Investigative Site 10031 - Huntington Beach, California, United States
- Los Angeles, CA Investigative Site 10089 - Los Angeles, California, United States
- Sacramento, CA Investigative Site 10024 - Sacramento, California, United States
- San Francisco, CA Investigative Site 10023 - San Francisco, California, United States
- Tarzana, CA Investigative Site 10409 - Tarzana, California, United States
- Van Nuys, CA Investigative Site 10109 - Van Nuys, California, United States
- West Hills, CA Investigative Site 10013 - West Hills, California, United States
- Aurora, CO Investigative Site 10001 - Aurora, Colorado, United States
- Denver, CO Investigative Site 10005 - Denver, Colorado, United States
- Bradenton, FL Investigative Site 10125 - Bradenton, Florida, United States
- Brooksville, FL Investigative Site 10077 - Brooksville, Florida, United States
- Fort Lauderdale, FL Investigative Site 10114 - Fort Lauderdale, Florida, United States
- Fort Myers, FL Investigative Site 10076 - Fort Myers, Florida, United States
- Hialeah, FL Investigative Site 10104 - Hialeah, Florida, United States
- Jacksonville, FL Investigative Site 10028 - Jacksonville, Florida, United States
- Miami, FL Investigative Site 10105 - Miami, Florida, United States
- Miami, FL Investigative Site 10040 - Miami, Florida, United States
- Miramar, FL Investigative Site 10113 - Miramar, Florida, United States
- Tamarac, Florida Investigative Site 10127 - Tamarac, Florida, United States
- Atlanta, GA Investigative Site 10022 - Atlanta, Georgia, United States
- Duluth, GA Investigative Site 10083 - Duluth, Georgia, United States
- Boise, Idaho Investigative Site 10073 - Boise, Idaho, United States
- Chicago, IL Investigative Site 10062 - Chicago, Illinois, United States
- Glenview, IL Investigative Site 10021 - Glenview, Illinois, United States
- Naperville, IL Investigative Site 10025 - Naperville, Illinois, United States
- Peoria, IL Investigative Site 10019 - Peoria, Illinois, United States
- Peoria, IL Investigative Site 10010 - Peoria, Illinois, United States
- Indianapolis, IN Investigative Site 10074 - Indianapolis, Indiana, United States
- Indianapolis, IN Investigative Site 10008 - Indianapolis, Indiana, United States
- Merrillville, IN Investigative Site 10064 - Merrillville, Indiana, United States
- Kansas City, KS Investigative Site 10060 - Kansas City, Kansas, United States
- Cynthiana, KY Investigative Site 10124 - Cynthiana, Kentucky, United States
- Lexington, KY Investigative Site 10080 - Lexington, Kentucky, United States
- Lexington, KY Investigative Site 10118 - Lexington, Kentucky, United States
- Louisville, KY Investigative Site 10006 - Louisville, Kentucky, United States
- Louisville, KY Investigative Site 10086 - Louisville, Kentucky, United States
- Paducah, KY Investigative Site 10079 - Paducah, Kentucky, United States
- Baton Rouge, LA Investigative Site 10030 - Baton Rouge, Louisiana, United States
- Hammond, LA Investigative Site 10106 - Hammond, Louisiana, United States
- West Monroe, LA Investigative Site 10090 - West Monroe, Louisiana, United States
- Baltimore, MD Investigative Site 10101 - Baltimore, Maryland, United States
- Bowie, MD Investigative Site 10020 - Bowie, Maryland, United States
- Boston, MA Investigative Stie 10087 - Boston, Massachusetts, United States
- Minneapolis, MN Investigative Site 10091 - Minneapolis, Minnesota, United States
- Minneapolis, MN Investigative Site 10035 - Minneapolis, Minnesota, United States
- Tupelo, MS Investigative Site 10100 - Tupelo, Mississippi, United States
- Kansas City, MO Investigative Site 10002 - Kansas City, Missouri, United States
- Omaha, NE Investigative Site 10018 - Omaha, Nebraska, United States
- Camden, NJ Investigative Site 10033 - Camden, New Jersey, United States
- Roslyn, NY Investigative Site 10058 - Roslyn, New York, United States
- Stony Brook, NY Investigative Site 10017 - Stony Brook, New York, United States
- Greenville, NC Investigative Site 10122 - Greenville, North Carolina, United States
- Akron, OH Investigative Site 10081 - Akron, Ohio, United States
Showing 60 of 356 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →