Study to Evaluate the Efficacy (Effect on Disease) and Safety of Finerenone in Participants With Heart Failure and Left Ventricular Ejection Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to 40%
Public ClinicalTrials.gov record NCT04435626. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity and Mortality in Participants With Heart Failure (NYHA II-IV) and Left Ventricular Ejection Fraction ≥ 40% (LVEF ≥ 40%)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the effect of finerenone compared to placebo (a tablet without active substance) in the reduction of cardiovascular death (generally meaning death due to disease of the heart or blood vessels) and total Heart Failure (HF) events, including HF hospitalization and urgent visits for HF(generally meaning a hospital stay or urgent presentation to a healthcare unit due to worsening symptoms of heart failure) in patients suffering from HF with an ejection fraction greater than or equal to 40%. Researchers will also collect information on how much the heart disease has impact on patient's lives, change of kidney function, and how well finerenone treatment is tolerated. The study plans to enroll 6000 male and female patients of the age of 40 years and above suffering from heart failure with ejection fraction greater than or equal to 40%. Participants will take the study product as oral tablet with a dose between 0 (Placebo) 40 mg once daily. Study duration will be up to 43 months.
Study identification
- NCT ID
- NCT04435626
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 6,016 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2020 (Actual)
- Primary completion
- May 15, 2024 (Actual)
- Completion
- Jun 14, 2024 (Actual)
- Last update posted
- Aug 26, 2025
2020 – 2024
United States locations
- U.S. sites
- 107
- U.S. states
- 34
- U.S. cities
- 101
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cardiology, PC | Birmingham | Alabama | 35211 | — |
| Eastern Shore Research Institute, LLC | Fairhope, AL | Fairhope | Alabama | 36532 | — |
| Mobile Heart Specialists - Providence | Mobile | Alabama | 36608 | — |
| University of Arizona Clinical and Translational Sciences Research Center | Tucson | Arizona | 85724 | — |
| Heart Clinic Arkansas | Little Rock | Arkansas | 72205 | — |
| WestSide Medical | Beverly Hills | California | 90211 | — |
| CA Heart and Vein Specialists | Huntington Beach | California | 92648 | — |
| UCI Medical Center - Neurology | Orange | California | 92868 | — |
| Sutter Medical Center - Cardiology | Sacramento | California | 95816 | — |
| NorthBay Clinical Research, LLC | Santa Rosa, CA | Santa Rosa | California | 95405 | — |
| The Lundquist Institute - Gynecology | Torrance | California | 90502 | — |
| Blue Coast Research Center, LLC | Vista | California | 92081 | — |
| Interventional Cardio Medical- DCT Department | West Hills | California | 91307 | — |
| Interventional Cardiology Medical Group | West Hills, CA | West Hills | California | 91307 | — |
| VA Eastern Colorado Health Care System | Aurora | Colorado | 80045 | — |
| Colorado Springs Cardiology - Woodmen Medical Plaza | Colorado Springs | Colorado | 80923 | — |
| South Denver Cardiology Associates, PC | Littleton | Colorado | 80120 | — |
| Cardiovascular & Vein Center of Florida | Bradenton, FL | Bradenton | Florida | 34209 | — |
| Nova Clinical Research - Blake Medical Center | Bradenton | Florida | 34209 | — |
| Cardiology Associates Research Company | Daytona Beach | Florida | 32117 | — |
| North Florida Foundation for Research and Education - Clinical Trial Center | Gainesville | Florida | 32608 | — |
| LifeSpring Research Foundation, LLC | Miami | Florida | 33130 | — |
| Southwest Florida Research | Naples, FL | Naples | Florida | 34102-8143 | — |
| East Coast Institute for Research | St. Augustine, FL | Saint Augustine | Florida | 32086 | — |
| Cardiology Partners Clinical Research Institute | Wellington Office | Wellington | Florida | 33449 | — |
| Centricity Research at Talbotton | Columbus | Georgia | 31904 | — |
| Atlanta Heart Specialists - Tucker | Tucker | Georgia | 30084 | — |
| Advocate Illinois Masonic Medical Center - Cardiology | Chicago | Illinois | 60657 | — |
| Advocate Good Samaritan Hospital - Cardiology | Downers Grove | Illinois | 60515 | — |
| Advocate Condell Medical Center | Libertyville | Illinois | 60048 | — |
| Edward Hospital - Main Campus - Cardiology | Naperville | Illinois | 60540 | — |
| Captain James A. Lovell Federal Health Care Center | North Chicago | Illinois | 60064 | — |
| Carle Health Methodist Hospital - Cardiology | Peoria | Illinois | 61603 | — |
| Midwest Cardiovascular Research and Education Foundation | Elkhart, IN | Elkhart | Indiana | 46514 | — |
| Reid Physicians Associates - Cardiology Department | Richmond | Indiana | 47374 | — |
| Kansas Nephrology Research Institute | Wichita | Kansas | 67214 | — |
| Baptist Health Paducah - Cardiology | Paducah | Kentucky | 42003 | — |
| Cardiovascular Associates Research, LLC | Covington | Louisiana | 70433 | — |
| Heart Clinic of Hammond | Hammond | Louisiana | 70403 | — |
| Louisiana Heart Center - Slidell | Slidell | Louisiana | 70458 | — |
| Southern Clinical Research, LLC | Zachary | Louisiana | 70791 | — |
| MaineHealth Cardiology - Scarborough | Scarborough | Maine | 04039 | — |
| Johns Hopkins Hospital - Cardiology | Baltimore | Maryland | 21287 | — |
| Suburban Hospital - Cardiology | Bethesda | Maryland | 20814 | — |
| Cardiovascular Specialists of Central Maryland, PA | Columbia | Maryland | 21044 | — |
| Henry Ford Hospital - OB/GYN | Detroit | Michigan | 48202 | — |
| AA Medical Research Center | Flint, MI | Flint | Michigan | 48504 | — |
| M Health Fairview Heart Clinic - Maplewood | Maplewood | Minnesota | 55109 | — |
| M Health Fairview Heart Clinic - Fulton | Minneapolis | Minnesota | 55455 | — |
| St. Cloud Hospital | Saint Cloud | Minnesota | 56303 | — |
| Baptist Heart -Cardiology - DCT Dept | Jackson | Mississippi | 39202 | — |
| University Hospital - UMMC - Nephrology | Jackson | Mississippi | 39216 | — |
| Harry S Truman Memorial Veterans Hospital - Cardiology | Columbia | Missouri | 65201 | — |
| Clinical Research Consultants | Kansas City | Missouri | 64111 | — |
| Saint Luke's Mid America Heart Institute | Kansas City | Missouri | 64111 | — |
| Mercy Hospital Springfield - Cardiology | Springfield | Missouri | 65804 | — |
| Logan Health Research | Kalispell | Montana | 59901 | — |
| CHI Health Clinic Heart Institute - Grand Island | Grand Island | Nebraska | 68803 | — |
| CHI Health Nebraska Heart | Lincoln | Nebraska | 68526 | — |
| Advanced Heart Care, LLC | Bridgewater, NJ | Bridgewater | New Jersey | 08807 | — |
| NJ Heart | Linden, NJ | Linden | New Jersey | 07036 | — |
| Garden State Heart Care | Manalapan | New Jersey | 07726 | — |
| Nuvance Health - The Heart Center | Poughkeepsie | New York | 12601 | — |
| Division of Cardiovascular Research at Peconic Bay Medical Center | Riverhead | New York | 11901 | — |
| Laurelton Heart Specialists | Rosedale | New York | 11422 | — |
| Saratoga Clinical Research, LLC | Saratoga Springs | New York | 12866 | — |
| Cardiac Care & Vascular Medicine | The Bronx | New York | 10469 | — |
| Northwell Health Physician Partners Cardiology at Valley Stream | Valley Stream | New York | 11580 | — |
| Kernodle Clinic West | Burlington | North Carolina | 27215 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Kettering Health Network | Research Institute | Kettering | Ohio | 45429 | — |
| Rama Research LLC | Marion, OH | Marion | Ohio | 43302-6774 | — |
| Mercy Health - St. Elizabeth Youngstown Hospital | Youngstown | Ohio | 44501 | — |
| South Oklahoma Heart Research, LLC | Oklahoma City | Oklahoma | 73135 | — |
| Capital Area Research | Camp Hill, PA | Camp Hill | Pennsylvania | 17011 | — |
| Doylestown Health Cardiology - DCA | Doylestown | Pennsylvania | 18901 | — |
| Kent Hospital | Warwick | Rhode Island | 02886 | — |
| Trident Cardiology Associates, PA | Ladson | South Carolina | 29456 | — |
| Carolina Heart Specialists | Lancaster, SC | Lancaster | South Carolina | 29720 | — |
| Monument Health Clinical Research | Rapid City | South Dakota | 57701 | — |
| Sanford USD Medical Center - Cardiology | Sioux Falls | South Dakota | 57105 | — |
| The Stern Cardiovascular Foundation - Germantown, TN | Germantown | Tennessee | 38138 | — |
| Apex Research Foundation, LLC. | Jackson, TN | Jackson | Tennessee | 38301 | — |
| Lt. Col. Luke Weathers, Jr. VA Medical Center - Cardiology | Memphis | Tennessee | 38105 | — |
| Cardiovascular Research of Knoxville | Powell | Tennessee | 37849 | — |
| Ascension Seton Heart Specialty Care and Transplant Center | Austin | Texas | 78705 | — |
| Texas Health & Vascular Specialists - Dallas | Dallas | Texas | 75231 | — |
| Southwest Family Medicine Associates | Dallas, TX | Dallas | Texas | 75235 | — |
| Texas Health Family Care - W Vickery Blvd | Fort Worth | Texas | 76107 | — |
| University of Texas Medical Branch at Galveston | Galveston | Texas | 77555 | — |
| Houston Heart & Vascular Associates | Humble | Texas | 77338 | — |
| South Texas Cardiovascular Consultants, PLLC / Kerrville, TX | Kerrville | Texas | 78028 | — |
| North Dallas Research Associates | McKinney | Texas | 75069 | — |
| ClinRx Research, LLC | Plano | Texas | 75024 | — |
| South Texas Cardiovascular Consultants - San Antonio | San Antonio | Texas | 78201 | — |
| Clinical Advancement Center, PLLC | San Antonio | Texas | 78212 | — |
| Northwest Houston Clinical Research - Tomball | Tomball | Texas | 77375 | — |
| University of Utah Clinical Neurosciences Center | Salt Lake City | Utah | 84312 | — |
| Inova Cardiology- Fairfax | Fairfax | Virginia | 22031 | — |
| Virginia Heart | Falls Church | Virginia | 22042 | — |
| Virginia Heart - Leesburg | Leesburg | Virginia | 20176 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Salem VA Medical Center - Cardiology | Salem | Virginia | 24153 | — |
| Selma Medical Associates | Winchester | Virginia | 22601 | — |
| William S. Middleton Memorial Veterans Hospital | Madison | Wisconsin | 53705 | — |
| Aurora Saint Luke's Medical Center - Cardiology | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 554 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04435626, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 26, 2025 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04435626 live on ClinicalTrials.gov.