RecruitingPhase 3NCT06024746

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)

Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF)

Sponsor

Colorado Prevention Center

Enrollment

1,500 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure

Summary

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (CONFIRMATION-HF) is testing whether combining two heart failure drugs — finerenone and an SGLT2 inhibitor — is safe and effective when started in patients hospitalized for heart failure. **You may be eligible if...** - You are 18 or older and are currently hospitalized or were recently discharged for heart failure - You had elevated heart failure markers (BNP or NT-proBNP) at or near admission - You received at least one IV dose of a diuretic (water pill) during this hospitalization - Your condition has stabilized according to the study's criteria **You may NOT be eligible if...** - You have type 1 diabetes or a history of diabetic ketoacidosis - You have a documented history of severe high potassium while on MRA medications - You are already taking a non-steroidal MRA or SGLT2 inhibitor - Your kidney function is very low (eGFR below 30) or your potassium is above 5.0 mmol/L - You are pregnant or not using adequate contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFinerenone

Oral finerenone.

DRUGEmpagliflozin

Oral empagliflozin.

Locations(15)

CON-10004 Fairhope, AL Investigational Site

Fairhope, Alabama, United States

CON-10075 El Centro, CA Investigational Site

El Centro, California, United States

CON-10024 Sacramento, CA Investigational Site

Sacramento, California, United States

CON-10022 Atlanta, GA Investigational Site

Atlanta, Georgia, United States

CON-10030 Baton Rouge, LA Investigational Site

Baton Rouge, Louisiana, United States

CON-10002 Kansas City, MO Investigative Site

Kansas City, Missouri, United States

CON-10045 Amarillo, TX Investigational Site

Amarillo, Texas, United States

CON-10015 Austin, TX Investigational Site

Austin, Texas, United States

CON-21003 Goiania, Goias Investigational Site

Goiânia, Goiás, Brazil

CON-21007 Joinville, Santa Catarina Investigational Site

Joinville, Santa Catarina, Brazil

CON-21004 Braganca Paulista, Sao Paulo Investigational Site

Bragança Paulista, São Paulo, Brazil

CON-21049 Sao Paulo, Sao Paulo Investigational Site

São Paulo, São Paulo, Brazil

CON-11012 Surry, BC Investigational Site

Surrey, British Columbia, Canada

CON-11007 North York, ON Investigational Site

North York, Ontario, Canada

CON-11005 Sherbrooke, QC Investigational Site

Sherbrooke, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06024746

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