A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Purpose
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.
Conditions
- Heart Failure
- Acute Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Finerenone |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Birmingham, AL Investigative Site 10012
Birmingham, Alabama 35205
Birmingham, Alabama 35205
Fairhope, AL Investigative Site 10004
Fairhope, Alabama 36532
Fairhope, Alabama 36532
Huntsville, AL Investigative Site 10026
Huntsville, Alabama 35801
Huntsville, Alabama 35801
Glendale, AZ Investigative Site 10096
Glendale, Arizona 85304
Glendale, Arizona 85304
Phoenix, AZ Investigative Site 10115
Phoenix, Arizona 85006
Phoenix, Arizona 85006
Scottsdale, AZ Investigative Site 10003
Scottsdale, Arizona 85258
Scottsdale, Arizona 85258
Chula Vista, CA Investigative Site 10111
Chula Vista, California 91911
Chula Vista, California 91911
Huntington Beach, CA Investigative Site 10031
Huntington Beach, California 92648
Huntington Beach, California 92648
Los Angeles, CA Investigative Site 10089
Los Angeles, California 90073
Los Angeles, California 90073
Sacramento, CA Investigative Site 10024
Sacramento, California 95816
Sacramento, California 95816
San Francisco, CA Investigative Site 10023
San Francisco, California 94118
San Francisco, California 94118
Tarzana, CA Investigative Site 10409
Tarzana, California 91356
Tarzana, California 91356
Van Nuys, CA Investigative Site 10109
Van Nuys, California 91405
Van Nuys, California 91405
West Hills, CA Investigative Site 10013
West Hills, California 91307
West Hills, California 91307
Aurora, CO Investigative Site 10001
Aurora, Colorado 80045
Aurora, Colorado 80045
Denver, CO Investigative Site 10005
Denver, Colorado 80204
Denver, Colorado 80204
Bradenton, FL Investigative Site 10125
Bradenton, Florida 34209
Bradenton, Florida 34209
Brooksville, FL Investigative Site 10077
Brooksville, Florida 34613
Brooksville, Florida 34613
Fort Lauderdale, FL Investigative Site 10114
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Fort Myers, FL Investigative Site 10076
Fort Myers, Florida 33919
Fort Myers, Florida 33919
Hialeah, FL Investigative Site 10104
Hialeah, Florida 33012
Hialeah, Florida 33012
Jacksonville, FL Investigative Site 10028
Jacksonville, Florida 32209
Jacksonville, Florida 32209
Miami, FL Investigative Site 10105
Miami, Florida 33135
Miami, Florida 33135
Miami, FL Investigative Site 10040
Miami, Florida 33173
Miami, Florida 33173
Atlanta, GA Investigative Site 10022
Atlanta, Georgia 30303
Atlanta, Georgia 30303
Duluth, GA Investigative Site 10083
Duluth, Georgia 30096
Duluth, Georgia 30096
Boise, Idaho Investigative Site 10073
Boise, Idaho 83712
Boise, Idaho 83712
Chicago, IL Investigative Site 10062
Chicago, Illinois 60612
Chicago, Illinois 60612
Glenview, IL Investigative Site 10021
Glenview, Illinois 60026
Glenview, Illinois 60026
Naperville, IL Investigative Site 10025
Naperville, Illinois 60540
Naperville, Illinois 60540
Peoria, IL Investigative Site 10019
Peoria, Illinois 61603
Peoria, Illinois 61603
Peoria, IL Investigative Site 10010
Peoria, Illinois 61614
Peoria, Illinois 61614
Indianapolis, IN Investigative Site 10074
Indianapolis, Indiana 46237
Indianapolis, Indiana 46237
Indianapolis, IN Investigative Site 10008
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Merrillville, IN Investigative Site 10064
Merrillville, Indiana 46410
Merrillville, Indiana 46410
Kansas City, KS Investigative Site 10060
Kansas City, Kansas 66103
Kansas City, Kansas 66103
Cynthiana, KY Investigative Site 10124
Cynthiana, Kentucky 41031
Cynthiana, Kentucky 41031
Lexington, KY Investigative Site 10080
Lexington, Kentucky 40503
Lexington, Kentucky 40503
Lexington, KY Investigative Site 10118
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Louisville, KY Investigative Site 10006
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Paducah, KY Investigative Site 10079
Paducah, Kentucky 42003
Paducah, Kentucky 42003
Baton Rouge, LA Investigative Site 10030
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
Hammond, LA Investigative Site 10106
Hammond, Louisiana 70403
Hammond, Louisiana 70403
West Monroe, LA Investigative Site 10090
West Monroe, Louisiana 71291
West Monroe, Louisiana 71291
Baltimore, MD Investigative Site 10101
Baltimore, Maryland 21287
Baltimore, Maryland 21287
Bowie, MD Investigative Site 10020
Bowie, Maryland 20715
Bowie, Maryland 20715
Boston, MA Investigative Stie 10087
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Minneapolis, MN Investigative Site 10091
Minneapolis, Minnesota 55407-1139
Minneapolis, Minnesota 55407-1139
Minneapolis, MN Investigative Site 10035
Minneapolis, Minnesota 55417
Minneapolis, Minnesota 55417
Kansas City, MO Investigative Site 10002
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Omaha, NE Investigative Site 10018
Omaha, Nebraska 68105
Omaha, Nebraska 68105
Camden, NJ Investigative Site 10033
Camden, New Jersey 08103
Camden, New Jersey 08103
Roslyn, NY Investigative Site 10058
Roslyn, New York 11576
Roslyn, New York 11576
Stony Brook, NY Investigative Site 10017
Stony Brook, New York 11794-8171
Stony Brook, New York 11794-8171
Greenville, NC Investigative Site 10122
Greenville, North Carolina 27834
Greenville, North Carolina 27834
Akron, OH Investigative Site 10081
Akron, Ohio 44304
Akron, Ohio 44304
Centerville, OH Investigative Site 10119
Centerville, Ohio 45459
Centerville, Ohio 45459
Cincinnati, OH Investigative Site 10088
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Bartlesville, OK Investigative Site 10095
Bartlesville, Oklahoma 74006
Bartlesville, Oklahoma 74006
Philadelphia, PA Investigative Site 10068
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Pittsburg, PA Investigative Site 1044
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Providence, RI Investigative Site 10050
Providence, Rhode Island 02908
Providence, Rhode Island 02908
Charleston, SC Investigative Site 10056
Charleston, South Carolina 29425
Charleston, South Carolina 29425
Germantown, TN Investigative Site 10063
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Memphis, TN Investigative Site 10059
Memphis, Tennessee 38105
Memphis, Tennessee 38105
Nashville, TN Investigative Site 10071
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Amarillo, TX Investigative Site 10045
Amarillo, Texas 79106
Amarillo, Texas 79106
Austin, TX Investigative Site 10015
Austin, Texas 78705
Austin, Texas 78705
Dallas, TX Investigative Site 10042
Dallas, Texas 75216
Dallas, Texas 75216
Houston, TX Investigative Site 10085
Houston, Texas 77030
Houston, Texas 77030
Plano, TX Investigative Site 10014
Plano, Texas 75093
Plano, Texas 75093
Burlington, VT Investigative Site 10053
Burlington, Vermont 05401
Burlington, Vermont 05401
Norfolk, VA Investigative Site 10009
Norfolk, Virginia 23507
Norfolk, Virginia 23507
Richmond, VA Investigative Site 10069
Richmond, Virginia 23225
Richmond, Virginia 23225
Richmond, VA Investigative Site 10067
Richmond, Virginia 23249
Richmond, Virginia 23249
Contact:
Marc Bonaca, MD
+1-303-860-9900
Marc Bonaca, MD
+1-303-860-9900
Salem, VA Investigative Site 10048
Salem, Virginia 24153
Salem, Virginia 24153
Milwaukee, WI Investigative Site 10061
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- Status
- Recruiting
- Sponsor
- Colorado Prevention Center
Detailed Description
This is an international, randomized, double-blind, placebo-controlled, event-driven trial of finerenone for the treatment of hospitalized heart failure patients with mildly reduced or preserved ejection fraction.