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Completed Phase 3 Interventional Results available

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

ClinicalTrials.gov ID: NCT03037931

Public ClinicalTrials.gov record NCT03037931. 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.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:10 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency /and Sub-Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

Study identification

NCT ID
NCT03037931
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
American Regent, Inc.
Industry
Enrollment
3,065 participants

Conditions and interventions

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
Mar 15, 2017 (Actual)
Primary completion
Feb 2, 2023 (Actual)
Completion
Feb 2, 2023 (Actual)
Last update posted
Jul 3, 2024

2017 – 2023

United States locations

U.S. sites
188
U.S. states
39
U.S. cities
160
Facility City State ZIP Site status
Advanced Cardiovascular LLC Alexander City Alabama 35010 —
Advanced Cardiovascular, LLC Auburn Alabama 36830 —
IMC/Diagnostic & Medical Clinic Mobile Alabama 36604 —
University of South Alabama Mobile Alabama 36617 —
Alaska Heart & Vascular Institute Anchorage Alaska 99508 —
Verde Valley Medical Center Cottonwood Arizona 86326 —
Clinical Research Institute of Arizona, LLC Surprise Arizona 85374 —
Carondelet Heart and Vascular Institute - Cardiology East Tucson Arizona 85710 —
Sparks Regional Medical Center Fort Smith Arkansas 72901 —
NEA Baptist Clinic Jonesboro Arkansas 72401 —
Arkansas Heart Hospital Little Rock Arkansas 72211 —
Westside Medical Associates of Los Angeles Beverly Hills California 90211 —
Harbor-UCLA Medical Center Carson California 90509 —
Valley Clinical Trials, Inc. Covina California 91723 —
TriWest Research Associates, LLC El Cajon California 92020 —
California Heart Specialists Huntington Beach California 92648 —
First Valley Medical Group Lancaster California 93534 —
Healthcare Partners Affiliation Medical Group Long Beach California 90806 —
Axis Clinical Trials Los Angeles California 90036 —
St. Joseph Heritage-Healthcare Mission Viejo California 92691 —
Radin Cardiovascular Medical Group, Inc. Newport Beach California 92663 —
Valley Clinical Trials, Inc. Northridge California 91325 —
Pasadena Clinical Research Pasadena California 91105 —
Eugene Soroka, MD Inc. Port Hueneme California 93041 —
VA San Diego Health Care System San Diego California 92161 —
Interventional Cardiology Medical Group West Hills California 91307 —
South Denver Cardiology Associates, PC Littleton Colorado 80120 —
Danbury Hospital Danbury Connecticut 06810 —
Stamford Hospital Stamford Connecticut 06904 —
Christiana Care Newark Delaware 19718 —
Alfieri Cardiology Wilmington Delaware 19803 —
Cardiology Associates of South Florida Boynton Beach Florida 33472 —
Cardiovascular & Vein Center of Florida Bradenton Florida 34209 —
Innovative Research of West Florida, Inc. Clearwater Florida 33756 —
Avail Clinical Research, LLC DeLand Florida 32720 —
Riverside Clinical Research Edgewater Florida 32132 —
Memorial Regional Hospital Hollywood Florida 33021 —
St. Vincent's Healthcare - Riverside Jacksonville Florida 32204 —
UF Health Jacksonville Jacksonville Florida 32209 —
St. Vincent's Healthcare - Southside Recruiting Jacksonville Florida 32216 —
Mayo Clinic Florida Jacksonville Florida 32224 —
ProLive Medical Research Miami Florida 33130 —
Cordova Research Institute, LLC Miami Florida 33155 —
Med-Care Research Miami Florida 33165 —
ITB Research Miami Florida 33173 —
Vista Health Research Miami Florida 33176 —
Empire Clinical Research, LLC Miami Lakes Florida 33016 —
Florida Hospital Transplant Institute Orlando Florida 32804 —
Cardiology Partners Clinical Research Institute Palm Beach Gardens Florida 33410 —
Springfield Medical Center Panama City Florida 32401 —
Broward Research Center Pembroke Pines Florida 33024 —
South Florida Research Solutions, LLC Pembroke Pines Florida 33026 —
Cardiology Consultants Pensacola Florida 32501 —
Avanza Medical Research Center Pensacola Florida 32503 —
Professional Health Care of Pinellas St. Petersburg Florida 33713 —
Indian River Medical Center Vero Beach Florida 32960 —
Cardiology Partners Clinical Research Institute Wellington Florida 33449 —
Piedmont Heart Institute - Athens Athens Georgia 30606 —
Piedmont Heart Institute Atlanta Georgia 30309 —
University Cardiology Associates, LLC Augusta Georgia 30901 —
Augusta University Augusta Georgia 30912 —
Piedmont Heart Institute Fayetteville Fayetteville Georgia 30214 —
Georgia Arrhythmia Consultants and Research Institute Macon Georgia 31201 —
Mercer University Macon Georgia 31201 —
Atlanta Vanguard Research Institute Smyrna Georgia 30082 —
Saint Luke's Boise Medical Center Boise Idaho 83712 —
Mount Sinai Hospital Medical Center - Department of Cardiology Chicago Illinois 60608 —
Medicoricium, LLC Fairview Heights Illinois 62208 —
Parkview Research Center Fort Wayne Indiana 46845 —
Franciscan Physician Network - Indiana Heart Physicians Indianapolis Indiana 46237 —
St. Vincent Medical Group Indianapolis Indiana 46260 —
Indiana University Health Ball Memorial Hospital, Inc. Muncie Indiana 47303 —
Reid Physician Associates / Reid Health Richmond Indiana 47374 —
Beacon Medical Group Advanced Cardiovascular Specialists South Bend Indiana 46601 —
Alexandria Cardiology Clinic Alexandria Louisiana 71301 —
Heart Clinic of Hammond Hammond Louisiana 70403 —
Cardiovascular Institute of the South Houma Louisiana 70360 —
Tulane Heart & Vascular Institute New Orleans Louisiana 70112 —
Ochsner Health System New Orleans Louisiana 70121 —
Louisiana Heart Center Slidell Louisiana 70458 —
Maine Medical Partners Maine Health Cardiology Scarborough Maine 04074 —
Anne Arundel Health System Research Institute Annapolis Maryland 21401 —
Sinai Hospital of Baltimore Baltimore Maryland 21215 —
Suburban Hospital Bethesda Maryland 20814 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
NECCR Prima Care Research, LLC Fall River Massachusetts 02721 —
Genesys Regional Medical Center Grand Blanc Michigan 48439 —
Western Michigan University Homer Stryker M.D. School of Medicine Kalamazoo Michigan 49008 —
Michigan CardioVascular Institute at Covenant Medical Center Saginaw Michigan 48602 —
Allina Health System, dba Abbott Northwestern Hospital Minneapolis Minnesota 55407 —
Mayo Clinic Rochester Minnesota 55905 —
Cardiology Associates Research, LLC Tupelo Mississippi 38801 —
North Kansas City Hospital North Kansas City Missouri 64116 —
St. Louis Heart & Vascular, PC St Louis Missouri 63136 —
Nebraska Heart Institute Lincoln Nebraska 68526 —
CHI Health Research Center Omaha Nebraska 68124 —
University Medical Center of Southern Nevada Las Vegas Nevada 89102 —
Red Rock Clinical Research, LLC Las Vegas Nevada 89146 —
Monmouth Cardiology Associates, LLC Eatontown New Jersey 07724 —
Englewood Health Englewood New Jersey 07631 —
Advanced Heart & Vascular Institute of Hunterdon Flemington New Jersey 08822 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Saint Peter's University Hospital New Brunswick New Jersey 08901 —
Saint Michael's Medical Center Newark New Jersey 07102 —
Rutgers New Jersey Medical School Newark New Jersey 07103 —
AtlantiCare Regional Medical Center Pomona New Jersey 08240 —
The Valley Hospital Ridgewood New Jersey 07450 —
Cardio Metabolic Institute Somerset New Jersey 08873 —
Holy Name Medical Center Teaneck New Jersey 07666 —
New York Presbyterian Brooklyn Methodist Hospital Brooklyn New York 11215 —
Trinity Medical WNY, PC Cheektowaga New York 14227 —
Mount Sinai Hospital New York New York 10029 —
Rochester General Hospital Rochester New York 14621 —
Richmond University Medical Center Staten Island New York 10310 —
Stony Brook University Hospital Stony Brook New York 11794-7007 —
Circuit Clinical West Seneca New York 14224 —
Northtowns Cardiology, PLLC Williamsville New York 14221 —
Asheville Cardiology Associates Asheville North Carolina 28803 —
Duke University Heart Failure Research Durham North Carolina 27710 —
Medication Management, LLC Greensboro North Carolina 27401 —
Wake Forest University Health Sciences High Point North Carolina 27262 —
Duke Cardiology of Lumberton Lumberton North Carolina 28358 —
Monroe Biomedical Research Monroe North Carolina 28112 —
Crossroads Clinical Research, Inc. Mooresville North Carolina 28117 —
Pinehurst Medical Clinic, Inc. Pinehurst North Carolina 28374 —
NC Heart & Vascular Research Raleigh North Carolina 27607 —
WakeMed Health and Hospitals Raleigh North Carolina 27610 —
PMG Research of Wilmington Wilmington North Carolina 28401 —
Trinity Health Center - Medical Arts Minot North Dakota 58701 —
Aultman Cardiology Clinical Trials Canton Ohio 44710 —
The MetroHealth System Cleveland Ohio 44109 —
The Cleveland Clinic Foundation Cleveland Ohio 44195 —
The Ohio State University Columbus Ohio 43210 —
North Ohio Heart Center Elyria Ohio 44035 —
North Ohio Heart Center Sandusky Ohio 44870 —
Heart House Research Foundation Springfield Ohio 45505 —
South Oklahoma Heart Research, LLC Oklahoma City Oklahoma 73135 —
Abington Memorial Hospital Abington Pennsylvania 19001 —
Penn State Health Holy Spirit Medical Center Geisinger - Cardiology Camp Hill Pennsylvania 17011 —
Lancaster General Hospital Lancaster Pennsylvania 17602 —
Drexel University Philadelphia Pennsylvania 19102 —
Hospital of the University of Pennsylvania Philadelphia Pennsylvania 19104 —
University of Pennsylvania - Perelman Center for Advanced Medicine Philadelphia Pennsylvania 19104 —
V.A. Pittsburgh Healthcare System Pittsburgh Pennsylvania 15240 —
Prisma Health Columbia South Carolina 29203 —
Self Regional Hospital Research Center Greenwood South Carolina 29646 —
Carolina Heart Specialists Lancaster South Carolina 29720 —
Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc. Rapid City South Dakota 57701 —
Stern Cardiovascular Foundation Germantown Tennessee 38138 —
Tennova Healthcare-Turkey Creek Medical Center Knoxville Tennessee 37934 —
Parkway Cardiology Associates, PC Oak Ridge Tennessee 37830 —
Amarillo Hearth Clinical Research Institute, Inc. Amarillo Texas 79106 —
PharmaTex Research Amarillo Texas 79106 —
Dallas VA Medical Center Dallas Texas 75216 —
Cardiovascular Research Institute of Dallas Dallas Texas 75231 —
Southwest Family Medicine Associates Dallas Texas 75235 —
Baylor University Medical Center Dallas Texas 75246 —
Texas Health Research & Education Institute Fort Worth Texas 76104 —
Texas Heart Institute Houston Texas 77030 —
Houston Heart & Vascular Associates Kingwood Texas 77339 —
Caprock Cardiac Center Research Institute, Inc. Lubbock Texas 79410 —
Angelina Medical Research, LLC Lufkin Texas 75904 —
North Dallas Research Associates McKinney Texas 75069 —
North Texas Research Associates McKinney Texas 75701 —
South Texas Cardiovascular Consultants, PLLC San Antonio Texas 78201 —
Baylor Scott & White Medical Center Temple Texas 76508 —
PharmaTex Research Tyler Texas 75701 —
The University of Texas Health Center at Tyler Tyler Texas 75708 —
Wichita Falls Heart Clinic Wichita Falls Texas 76301 —
Advanced Clinical Research/Intermountain Heart Center PC West Jordan Utah 84088 —
The University of Vermont Medical Center Burlington Vermont 05401 —
Stroobants Cardiovascular Center Lynchburg Virginia 24501 —
Riverside Cardiology Specialists Newport News Virginia 23601 —
Sentara Norfolk General Hospital Norfolk Virginia 23507 —
Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J) Richmond Virginia 23249 —
VCU Medical Center Richmond Virginia 23298 —
Carilion Medical Center Roanoke Virginia 24014 —
Selma Medical Associates Winchester Virginia 22601 —
Providence Regional Medical Center Everett Everett Washington 98201 —
Swedish Heart & Vascular-Advanced Cardiac Support Program Seattle Washington 98122 —
Providence Sacred Heart Medical Center & Children's Hospital Spokane Washington 99204 —
CHI Franciscan Research Center Tacoma Washington 98405 —
Walla Walla Clinic Walla Walla Washington 99362 —
Wenatchee Valley Hospital & Clinics Wenatchee Washington 98801 —
Marshfield Clinic Marshfield Wisconsin 54449 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —
ProHealth Care Inc / Waukesha Memorial Hospital Waukesha Wisconsin 53188 —

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 157 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03037931, 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 Jul 3, 2024 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03037931 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →