A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients With Heart Failure Who Are Intolerant or Not Eligible for Treatment With Steroidal Mineralocorticoid Receptor Antagonists
Recruiting · NCT06033950 · Interventional (participants receive a specific treatment) · Lead sponsor: Colorado Prevention Center
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 with heart failure and reduced ejection fraction (HFrEF) who are intolerant or ineligible to receive treatment with steroidal mineralocorticoid receptor antagonists (sMRA).
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 electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
- Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
- Symptomatic HFrEF per protocol defined criteria
- Not on sMRA due to history of intolerance, contraindication, or ineligibility for treatment
- Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)
Exclusion criteria
- Treatment with non-steroidal MRA (nsMRA)
- Documented prior history of severe hyperkalemia in the setting of MRA use
- eGFR \< 25 mL/min/1.73m² and / or potassium \> 5.0 mmol/L
- Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days or planned
- Prior or planned heart transplant
- Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure
- Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- Cardiomyopathy due to known acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
- Probable alternative cause of participant's HF
- Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors, or moderate or potent CYP3A4 inducers
- Known hypersensitivity to the IP (active substance or excipients)
- Any other condition or therapy which would make the participant unsuitable for the study
- Concurrent or previous participation in another interventional clinical study using an investigational agent within 30 days prior to randomization
Where it is running
60 locations listed across 19 US states.
- FIN-10004 Fairhope, AL Investigational Site - Fairhope, Alabama, United States
- Phoenix, AZ Investigative Site FIN-10115 - Phoenix, Arizona, United States
- FIN-10401, Yuma, AZ - Yuma, Arizona, United States
- Chula Vista, CA Investigative Site FIN-10419 - Chula Vista, California, United States
- Chula Vista, CA Investigative Site FIN-10111 - Chula Vista, California, United States
- FIN-10407, Northridge, CA - Northridge, California, United States
- FIN-10412, Orange, CA - Orange, California, United States
- FIN-10070, Pamona, CA - Pomona, California, United States
- FIN-10024, Sacramento, CA - Sacramento, California, United States
- FIN-10406, San Diego, CA - San Diego, California, United States
- San Diego, CA Investigative Site FIN-10420 - San Diego, California, United States
- FIN-10075 San Diego, CA Investigational Site - San Diego, California, United States
- San Francisco, CA Investigative Site FIN-10023 - San Francisco, California, United States
- FIN-10423, Sherman Oaks, CA - Sherman Oaks, California, United States
- FON-10409, Tarzana, CA - Tarzana, California, United States
- FIN-10109, Van Nuys, CA - Van Nuys, California, United States
- FIN-10408, West Covina, CA - West Covina, California, United States
- FIN-10013, West Hills, CA - West Hills, California, United States
- FIN-10110, Aurora, CO - Aurora, Colorado, United States
- FIN-10001, Aurora, CO - Aurora, Colorado, United States
- Bradenton, FL Investigative Site FIN-10125 - Bradenton, Florida, United States
- FIN-10104, Hialeah, FL - Hialeah, Florida, United States
- FIN-10028, Jacksonville, FL - Jacksonville, Florida, United States
- FIN-10105, Miami, FL - Miami, Florida, United States
- FIN-10113, Miramar, FL - Miramar, Florida, United States
- FIN-10019, Peoria, IL - Peoria, Illinois, United States
- FIN-10064, Merrillville, IN - Merrillville, Indiana, United States
- Cynthiana, KY Investigative Site FIN-10124 - Cynthiana, Kentucky, United States
- FIN-10080, Lexington, KY - Lexington, Kentucky, United States
- Lexington, KY Investigative Site FIN-10118 - Lexington, Kentucky, United States
- FIN-10086, Louisville, KY - Louisville, Kentucky, United States
- Louisville, KY Investigative Site FIN-10417 - Louisville, Kentucky, United States
- FIN-10079, Paducah, KY - Paducah, Kentucky, United States
- FIN-10030, Baton Rouge, LA - Baton Rouge, Louisiana, United States
- FIN-10106, Hammond, LA - Hammond, Louisiana, United States
- FIN-10090, West Monroe, LA - West Monroe, Louisiana, United States
- Minneapolis, MN Investigative Site FIN-10035 - Minneapolis, Minnesota, United States
- FIN-10002 Kansas City, MO Investigational Site - Kansas City, Missouri, United States
- FIN-10318, Charlotte, NC - Charlotte, North Carolina, United States
- Greenville, NC Investigative Site FIN-10122 - Greenville, North Carolina, United States
- FIN-10081, Akron, OH - Akron, Ohio, United States
- FIN-10119, Centerville, OH - Centerville, Ohio, United States
- FIN- 10112, Cincinnati, OH - Cincinnati, Ohio, United States
- Orangeburg, SC Investigative Site FIN-10433 - Orangeburg, South Carolina, United States
- FIN-10015 Austin, TX Investigational Site - Austin, Texas, United States
- FIN-10404, Denison, TX - Denison, Texas, United States
- FIN-10085, Houston, TX - Houston, Texas, United States
- Tyler, TX Investigative Site FIN-10422 - Tyler, Texas, United States
- FIN-10405, Layton, UT - Layton, Utah, United States
- FIN-10053, Burlington, VT - Burlington, Vermont, United States
- FIN-10402, Norfolk, VA - Norfolk, Virginia, United States
- FIN-10093, Richmond, VA - Richmond, Virginia, United States
- Salem, VA Investigative Site FIN-10048 - Salem, Virginia, United States
- Milwaukee, WI Investigative Site FIN-10428 - Milwaukee, Wisconsin, United States
- Barcelona Investigative Site FIN-38010 - Barcelona, Spain
- Budapest Investigative Site FIN-34001 - Budapest, Hungary
- Buenos Aires Investigative Site FIN-20031 - Buenos Aires, Argentina
- Córdoba Investigative Site FIN-20025 - Córdoba, Argentina
- Córdoba Investigative Site FIN-20030 - Córdoba, Argentina
- FIN-39001, Glasgow, UK - Glasgow, United Kingdom
Showing 60 of 176 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →