A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
Public ClinicalTrials.gov record NCT06935370. 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
EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) < 40%
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Study identification
- NCT ID
- NCT06935370
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 4,200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- May 19, 2025
- Primary completion
- Feb 3, 2029
- Completion
- Feb 21, 2029
- Last update posted
- Sep 2, 2026
2025 – 2029
United States locations
- U.S. sites
- 91
- U.S. states
- 21
- U.S. cities
- 80
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cure Clinical Research | Beverly Hills | California | 90211 | Suspended |
| Valley Clinical Trials, Inc. | Covina | California | 91723 | Recruiting |
| North Coast Cardiology | Encinitas | California | 92024 | Not yet recruiting |
| Merced Vein and Vascular Center | Merced | California | 95340 | Recruiting |
| Radin Cardiovascular Medical Group | Newport Beach | California | 92663 | Recruiting |
| Amicis Research Center - Nordhoff | Northridge | California | 91324 | Terminated |
| University of California San Diego | San Diego | California | 92103 | Not yet recruiting |
| Paradigm Clinical Research - San Diego | San Diego | California | 92108 | Recruiting |
| Amicis Research Corporate | Santa Clarita | California | 91355 | Terminated |
| Care Access Research | Thousand Oaks | California | 91360 | Recruiting |
| Bay Area Cardiology | Brandon | Florida | 33511 | Recruiting |
| Cardiology Associates Research Co. | Daytona Beach | Florida | 32117 | Recruiting |
| Suncoast Research Associates, LLC | Doral | Florida | 33172 | Recruiting |
| Malcom Randall VA Medical Center | Gainesville | Florida | 32608 | Recruiting |
| Velocity Clinical Research-Hallandale Beach-67888 | Hallandale | Florida | 33009 | Recruiting |
| University of Florida | Jacksonville | Florida | 32209 | Recruiting |
| East Coast Institute For Research, LLC | Jacksonville | Florida | 32216 | Recruiting |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | Recruiting |
| University of Miami - Miller School of Medicine | Miami | Florida | 33125 | Recruiting |
| Infinite Clinical Research Inc | Miami | Florida | 33133 | Recruiting |
| Inpatient Research Clinic, LLC | Miami Lakes | Florida | 33014 | Recruiting |
| Innovation Medical Research Center | Palmetto Bay | Florida | 33157 | Recruiting |
| Peace River Cardiovascular Center | Port Charlotte | Florida | 33952 | Recruiting |
| St. Johns Center for Clinical Research | Saint Augustine | Florida | 32086 | Recruiting |
| University of South Florida | Tampa | Florida | 33606 | Recruiting |
| Cardiology Partners Clinical Research Institute | Wellington | Florida | 33449 | Recruiting |
| Cozy Research LLC | Wesley Chapel | Florida | 33544 | Recruiting |
| Clinical Site Partners, LLC | Winter Park | Florida | 32789 | Recruiting |
| Atlanta Clinical Research Centers | Atlanta | Georgia | 30342 | Recruiting |
| NSC Research Inc | Johns Creek | Georgia | 30024 | Recruiting |
| Northwest Heart Clinical Research, LLC | Arlington Heights | Illinois | 60005 | Not yet recruiting |
| Illinois Masonic Hospital | Chicago | Illinois | 60657 | Not yet recruiting |
| Chicago Medical Research | Hazel Crest | Illinois | 60429 | Recruiting |
| Clinical Investigation Specialists, Inc. | Libertyville | Illinois | 60048 | Recruiting |
| AMR Park Ridge | Park Ridge | Illinois | 60068 | Recruiting |
| Springfield Clinic | Springfield | Illinois | 62703 | Recruiting |
| Midwest Cardiovascular Research and Education Foundation | Elkhart | Indiana | 46514 | Recruiting |
| St. Francis Medical Group-Indiana Heart Physicians, Inc | Indianapolis | Indiana | 46237 | Recruiting |
| Cardiovascular Research of Northwest Indiana, LLC | Munster | Indiana | 46321 | Recruiting |
| Reid Hospital | Richmond | Indiana | 47374 | Recruiting |
| The Iowa Clinic, PC | West Des Moines | Iowa | 50266 | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | Not yet recruiting |
| Kansas Nephrology Research Institute, LLC | Wichita | Kansas | 67214 | Recruiting |
| Robert J Dole Veterans Affairs Medical Center | Wichita | Kansas | 67218 | Recruiting |
| West Houston Area Clinical Trial Consultants, LLC | Wichita | Kansas | 67226 | Recruiting |
| Heart Clinic of Hammond | Hammond | Louisiana | 70403 | Recruiting |
| Grace Research, LLC-Shreveport-64616 | Shreveport | Louisiana | 71105 | Suspended |
| Ascension Saint Agnes Heart Care | Baltimore | Maryland | 21229 | Recruiting |
| Metropolitan Cardiovascular Consultants | Beltsville | Maryland | 20705 | Recruiting |
| Capitol Cardiology Associates | Lanham | Maryland | 20706 | Recruiting |
| Cardiology and Vascular Associates - CAVA | Bloomfield Hills | Michigan | 48304 | Recruiting |
| Michigan Healthcare Professionals Pulse Cardiology | Farmington Hills | Michigan | 48334 | Recruiting |
| Henry Ford Providence Hospital | Southfield | Michigan | 48075 | Recruiting |
| Michigan Heart, PC | Ypsilanti | Michigan | 48197 | Recruiting |
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | Recruiting |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | Recruiting |
| Regions Hospital | Saint Paul | Minnesota | 55101 | Recruiting |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | Recruiting |
| St. Louis Heart and Vascular, P.C. | St Louis | Missouri | 63136 | Recruiting |
| Be Well Clinical Studies | Omaha | Nebraska | 68144 | Recruiting |
| Advanced Heart Care, LLC | Bridgewater | New Jersey | 08807 | Recruiting |
| Mount Sinai Hospital-New York-52529 | New York | New York | 10019 | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Recruiting |
| IMA Clinical Research Lenoir | Lenoir | North Carolina | 28645 | Recruiting |
| Pinehurst Medical Clinic, Inc. - East | Pinehurst | North Carolina | 28374 | Recruiting |
| WakeMed | Raleigh | North Carolina | 27610 | Recruiting |
| Piedmont Healthcare, Inc. | Statesville | North Carolina | 28625 | Recruiting |
| Wilmington Health | Wilmington | North Carolina | 28401 | Recruiting |
| VA Northeast Ohio Healthcare System | Cleveland | Ohio | 44106 | Not yet recruiting |
| K and R Research LLC | Marion | Ohio | 43302 | Recruiting |
| Cardiology Consultants of Philadelphia | Yardley | Pennsylvania | 19067 | Recruiting |
| Bon Secours Medical Group Greenville Specialty Care, LLC | Greenville | South Carolina | 29607 | Terminated |
| Pharmatex Research | Amarillo | Texas | 79109 | Recruiting |
| Amarillo Heart Clinical Research Institute, Incorporated | Amarillo | Texas | 79124 | Recruiting |
| NextStage Clinical Research | Beaumont | Texas | 77702-1513 | Recruiting |
| Clinical Research Solution, LLC | Cypress | Texas | 77429 | Recruiting |
| Texas Health Research and Education Institute | Dallas | Texas | 75231 | Recruiting |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | Recruiting |
| Helios CR Inc - Fort Worth | Fort Worth | Texas | 76104 | Recruiting |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | Recruiting |
| DM Clinical Research - Irving | Irving | Texas | 75061 | Recruiting |
| DCOL Center for Clinical Research | Longview | Texas | 75605 | Recruiting |
| North Texas Research Associates | McKinney | Texas | 75071 | Recruiting |
| Revival Research Institute, LLC - McKinney | McKinney | Texas | 75071 | Recruiting |
| Texas Institute Of Cardiology | McKinney | Texas | 75071 | Recruiting |
| Accurate Clinical Research, Inc. | Richmond | Texas | 77469 | Recruiting |
| Baylor Scott and White Health | Temple | Texas | 76508 | Recruiting |
| Northwest Heart Center | Tomball | Texas | 77375 | Recruiting |
| NextStage Clinical Research | Waco | Texas | 76712 | Recruiting |
| Carient Heart and Vascular | Manassas | Virginia | 20109 | Recruiting |
| Carilion Clinic | Roanoke | Virginia | 24014 | Recruiting |
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 497 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06935370, 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 Sep 2, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06935370 live on ClinicalTrials.gov.