Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
HEART-FID
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
1 other identifier
interventional
3,065
13 countries
345
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 heart-failure
Started Mar 2017
Longer than P75 for phase_3 heart-failure
345 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2023
CompletedResults Posted
Study results publicly available
July 3, 2024
CompletedJuly 3, 2024
February 1, 2024
5.9 years
January 25, 2017
February 2, 2024
June 7, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Deaths
The number of participants who died out of the total treated group.
1 year
Number of Hospitalizations for Heart Failure
The number of participants who were hospitalized for heart failure out of the total treated group.
1 year
Change in 6MWT (Six Minute Walk Test) Distance
The change in meters walked at baseline compared to 6 months later.
6 months
Study Arms (2)
Ferric Carboxymaltose
ACTIVE COMPARATORFerric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices.
Placebo
PLACEBO COMPARATORNormal saline 15ml - 2 doses 7 days apart repeated every 6 months.
Interventions
Eligibility Criteria
You may qualify if:
- Adult (≥18 years of age) able to provide signed, written informed consent.
- Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization.
- Able and willing to perform a six-minute walk test (6MWT) at the time of randomization.
- Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG), valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation.
- a. Left ventricular ejection fraction ≤ 40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction ≤ 40% within 24 months of screening visit ii. Historical value of ejection fraction ≤ 30% within 36 months of screening visit
- Hemoglobin \>9.0 g/dL and \< 13.5 g/dL (females) or \<15.0 g/dL (males) within 28 days of randomization.
- Serum ferritin \<100 ng/mL or 100 to 300 ng/mL with TSAT \<20%.Patients with screening ferritin \<15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization.
- Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) \> 600 pg/mL (or BNP \>200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP \>1000 pg/mL (or BNP \>400 pg/mL) .
You may not qualify if:
- Known hypersensitivity reaction to any component of FCM.
- History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
- Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment.
- Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention.
- Current atrial fibrillation or atrial flutter with a mean ventricular response rate \>100 per minute (at rest).
- Current or planned mechanical circulatory support or heart transplantation.
- Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
- Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase \>3 times the upper limit of normal range).
- Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
- Active gastrointestinal bleeding.
- Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
- Inability to return for follow up visits within the necessary windows
- Concurrently in a study with investigational product.
- No participants with Current Coronavirus Disease-19 (COVID-19) Infection into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Regent, Inc.lead
- Duke Clinical Research Institutecollaborator
Study Sites (345)
Advanced Cardiovascular LLC
Alexander City, Alabama, 35010, United States
Advanced Cardiovascular, LLC
Auburn, Alabama, 36830, United States
IMC/Diagnostic & Medical Clinic
Mobile, Alabama, 36604, United States
University of South Alabama
Mobile, Alabama, 36617, United States
Alaska Heart & Vascular Institute
Anchorage, Alaska, 99508, United States
Verde Valley Medical Center
Cottonwood, Arizona, 86326, United States
Clinical Research Institute of Arizona, LLC
Surprise, Arizona, 85374, United States
Carondelet Heart and Vascular Institute - Cardiology East
Tucson, Arizona, 85710, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901, United States
NEA Baptist Clinic
Jonesboro, Arkansas, 72401, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Westside Medical Associates of Los Angeles
Beverly Hills, California, 90211, United States
Harbor-UCLA Medical Center
Carson, California, 90509, United States
Valley Clinical Trials, Inc.
Covina, California, 91723, United States
TriWest Research Associates, LLC
El Cajon, California, 92020, United States
California Heart Specialists
Huntington Beach, California, 92648, United States
First Valley Medical Group
Lancaster, California, 93534, United States
Healthcare Partners Affiliation Medical Group
Long Beach, California, 90806, United States
Axis Clinical Trials
Los Angeles, California, 90036, United States
St. Joseph Heritage-Healthcare
Mission Viejo, California, 92691, United States
Radin Cardiovascular Medical Group, Inc.
Newport Beach, California, 92663, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Pasadena Clinical Research
Pasadena, California, 91105, United States
Eugene Soroka, MD Inc.
Port Hueneme, California, 93041, United States
VA San Diego Health Care System
San Diego, California, 92161, United States
Interventional Cardiology Medical Group
West Hills, California, 91307, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, 80120, United States
Danbury Hospital
Danbury, Connecticut, 06810, United States
Stamford Hospital
Stamford, Connecticut, 06904, United States
Christiana Care
Newark, Delaware, 19718, United States
Alfieri Cardiology
Wilmington, Delaware, 19803, United States
Cardiology Associates of South Florida
Boynton Beach, Florida, 33472, United States
Cardiovascular & Vein Center of Florida
Bradenton, Florida, 34209, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
St. Vincent's Healthcare - Riverside
Jacksonville, Florida, 32204, United States
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
St. Vincent's Healthcare - Southside Recruiting
Jacksonville, Florida, 32216, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
ProLive Medical Research
Miami, Florida, 33130, United States
Cordova Research Institute, LLC
Miami, Florida, 33155, United States
Med-Care Research
Miami, Florida, 33165, United States
ITB Research
Miami, Florida, 33173, United States
Vista Health Research
Miami, Florida, 33176, United States
Empire Clinical Research, LLC
Miami Lakes, Florida, 33016, United States
Florida Hospital Transplant Institute
Orlando, Florida, 32804, United States
Cardiology Partners Clinical Research Institute
Palm Beach Gardens, Florida, 33410, United States
Springfield Medical Center
Panama City, Florida, 32401, United States
Broward Research Center
Pembroke Pines, Florida, 33024, United States
South Florida Research Solutions, LLC
Pembroke Pines, Florida, 33026, United States
Cardiology Consultants
Pensacola, Florida, 32501, United States
Avanza Medical Research Center
Pensacola, Florida, 32503, United States
Professional Health Care of Pinellas
St. Petersburg, Florida, 33713, United States
Indian River Medical Center
Vero Beach, Florida, 32960, United States
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449, United States
Piedmont Heart Institute - Athens
Athens, Georgia, 30606, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
University Cardiology Associates, LLC
Augusta, Georgia, 30901, United States
Augusta University
Augusta, Georgia, 30912, United States
Piedmont Heart Institute Fayetteville
Fayetteville, Georgia, 30214, United States
Georgia Arrhythmia Consultants and Research Institute
Macon, Georgia, 31201, United States
Mercer University
Macon, Georgia, 31201, United States
Atlanta Vanguard Research Institute
Smyrna, Georgia, 30082, United States
Saint Luke's Boise Medical Center
Boise, Idaho, 83712, United States
Mount Sinai Hospital Medical Center - Department of Cardiology
Chicago, Illinois, 60608, United States
Medicoricium, LLC
Fairview Heights, Illinois, 62208, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Franciscan Physician Network - Indiana Heart Physicians
Indianapolis, Indiana, 46237, United States
St. Vincent Medical Group
Indianapolis, Indiana, 46260, United States
Indiana University Health Ball Memorial Hospital, Inc.
Muncie, Indiana, 47303, United States
Reid Physician Associates / Reid Health
Richmond, Indiana, 47374, United States
Beacon Medical Group Advanced Cardiovascular Specialists
South Bend, Indiana, 46601, United States
Alexandria Cardiology Clinic
Alexandria, Louisiana, 71301, United States
Heart Clinic of Hammond
Hammond, Louisiana, 70403, United States
Cardiovascular Institute of the South
Houma, Louisiana, 70360, United States
Tulane Heart & Vascular Institute
New Orleans, Louisiana, 70112, United States
Ochsner Health System
New Orleans, Louisiana, 70121, United States
Louisiana Heart Center
Slidell, Louisiana, 70458, United States
Maine Medical Partners Maine Health Cardiology
Scarborough, Maine, 04074, United States
Anne Arundel Health System Research Institute
Annapolis, Maryland, 21401, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Suburban Hospital
Bethesda, Maryland, 20814, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NECCR Prima Care Research, LLC
Fall River, Massachusetts, 02721, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
Western Michigan University Homer Stryker M.D. School of Medicine
Kalamazoo, Michigan, 49008, United States
Michigan CardioVascular Institute at Covenant Medical Center
Saginaw, Michigan, 48602, United States
Allina Health System, dba Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801, United States
North Kansas City Hospital
North Kansas City, Missouri, 64116, United States
St. Louis Heart & Vascular, PC
St Louis, Missouri, 63136, United States
Nebraska Heart Institute
Lincoln, Nebraska, 68526, United States
CHI Health Research Center
Omaha, Nebraska, 68124, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Red Rock Clinical Research, LLC
Las Vegas, Nevada, 89146, United States
Monmouth Cardiology Associates, LLC
Eatontown, New Jersey, 07724, United States
Englewood Health
Englewood, New Jersey, 07631, United States
Advanced Heart & Vascular Institute of Hunterdon
Flemington, New Jersey, 08822, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Cardio Metabolic Institute
Somerset, New Jersey, 08873, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Trinity Medical WNY, PC
Cheektowaga, New York, 14227, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
Stony Brook University Hospital
Stony Brook, New York, 11794-7007, United States
Circuit Clinical
West Seneca, New York, 14224, United States
Northtowns Cardiology, PLLC
Williamsville, New York, 14221, United States
Asheville Cardiology Associates
Asheville, North Carolina, 28803, United States
Duke University Heart Failure Research
Durham, North Carolina, 27710, United States
Medication Management, LLC
Greensboro, North Carolina, 27401, United States
Wake Forest University Health Sciences
High Point, North Carolina, 27262, United States
Duke Cardiology of Lumberton
Lumberton, North Carolina, 28358, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Crossroads Clinical Research, Inc.
Mooresville, North Carolina, 28117, United States
Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina, 28374, United States
NC Heart & Vascular Research
Raleigh, North Carolina, 27607, United States
WakeMed Health and Hospitals
Raleigh, North Carolina, 27610, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Trinity Health Center - Medical Arts
Minot, North Dakota, 58701, United States
Aultman Cardiology Clinical Trials
Canton, Ohio, 44710, United States
The MetroHealth System
Cleveland, Ohio, 44109, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
North Ohio Heart Center
Elyria, Ohio, 44035, United States
North Ohio Heart Center
Sandusky, Ohio, 44870, United States
Heart House Research Foundation
Springfield, Ohio, 45505, United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Penn State Health Holy Spirit Medical Center Geisinger - Cardiology
Camp Hill, Pennsylvania, 17011, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17602, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
V.A. Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Prisma Health
Columbia, South Carolina, 29203, United States
Self Regional Hospital Research Center
Greenwood, South Carolina, 29646, United States
Carolina Heart Specialists
Lancaster, South Carolina, 29720, United States
Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.
Rapid City, South Dakota, 57701, United States
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138, United States
Tennova Healthcare-Turkey Creek Medical Center
Knoxville, Tennessee, 37934, United States
Parkway Cardiology Associates, PC
Oak Ridge, Tennessee, 37830, United States
Amarillo Hearth Clinical Research Institute, Inc.
Amarillo, Texas, 79106, United States
PharmaTex Research
Amarillo, Texas, 79106, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231, United States
Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Texas Health Research & Education Institute
Fort Worth, Texas, 76104, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Houston Heart & Vascular Associates
Kingwood, Texas, 77339, United States
Caprock Cardiac Center Research Institute, Inc.
Lubbock, Texas, 79410, United States
Angelina Medical Research, LLC
Lufkin, Texas, 75904, United States
North Dallas Research Associates
McKinney, Texas, 75069, United States
North Texas Research Associates
McKinney, Texas, 75701, United States
South Texas Cardiovascular Consultants, PLLC
San Antonio, Texas, 78201, United States
Baylor Scott & White Medical Center
Temple, Texas, 76508, United States
PharmaTex Research
Tyler, Texas, 75701, United States
The University of Texas Health Center at Tyler
Tyler, Texas, 75708, United States
Wichita Falls Heart Clinic
Wichita Falls, Texas, 76301, United States
Advanced Clinical Research/Intermountain Heart Center PC
West Jordan, Utah, 84088, United States
The University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501, United States
Riverside Cardiology Specialists
Newport News, Virginia, 23601, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)
Richmond, Virginia, 23249, United States
VCU Medical Center
Richmond, Virginia, 23298, United States
Carilion Medical Center
Roanoke, Virginia, 24014, United States
Selma Medical Associates
Winchester, Virginia, 22601, United States
Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
Swedish Heart & Vascular-Advanced Cardiac Support Program
Seattle, Washington, 98122, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204, United States
CHI Franciscan Research Center
Tacoma, Washington, 98405, United States
Walla Walla Clinic
Walla Walla, Washington, 99362, United States
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, 98801, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
ProHealth Care Inc / Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
SWSLHD-Liverpool Hospital
Liverpool, New South Wales, 1871, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Core Research Group
Milton, Queensland, 4064, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011, Australia
SA Heart
Ashford, South Australia, 5035, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Heart Lung Clinic
Darlinghurst, Sydney, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Royal Adelaide Hospital
Adelaide, 5000, Australia
Macquarie University - Clinical Trials Unit
Macquarie Park, 2109, Australia
John Hunter Hospital
New Lambton Heights, 2305, Australia
Epworth HealthCare Clinical Trials
Richmond, 3121, Australia
MHAT Puls
Blagoevgrad, 2700, Bulgaria
Multiprofile Hospital for Active Treatment: Department of cardiology
Gabrovo, 5300, Bulgaria
MHAT Haskovo AD
Haskovo, 6304, Bulgaria
Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology
Lom, 3600, Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, 5800, Bulgaria
МC Hipokrena
Sevlievo, 5400, Bulgaria
Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology
Sofia, 1113, Bulgaria
Second Medical Center-Sofia, EEOD - Department of Cardiology
Sofia, 1202, Bulgaria
Second Multiprofile Hospital for Active Treatment
Sofia, 1202, Bulgaria
5th City Hospital
Sofia, 1233, Bulgaria
National Multiprofile Transport Hospital Cardiology Clinic
Sofia, 1233, Bulgaria
Medical Center Hera EOOD - Office of Cardiology
Sofia, 1510, Bulgaria
Multiprofile Regional Hospital for Active Treatment
Veliko Tarnovo, 5002, Bulgaria
Medical Center Velingrad 2017" EOOD, Office of Cardiology
Velingrad, 4600, Bulgaria
University of Calbary
Calgary, Alberta, T2N 4Z6, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
South Edmonton Cardiology Consultants
Edmonton, Alberta, T6L 6K3, Canada
Royal Alexandria Hospital
Edmonton, Alberta, Canada
Fraser Clinical Trials
New Westminster, British Columbia, V3L 3W4, Canada
SMH Cardiology Clinical Trials
Surrey, British Columbia, V3V 0C6, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6E 1M7, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R 4R2, Canada
G.A. Research Associates, Ltd.
Moncton, New Brunswick, Canada
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
Manna Research Inc., Burlington South
Burlington, Ontario, L7R 1A4, Canada
Cambridge Cardiac Care Center
Cambridge, Ontario, N1R 6V6, Canada
Vizel Cardiac Research
Cambridge, Ontario, N1R 7R1, Canada
London Health Sciences Center (LHSC)
London, Ontario, N6A 5A5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Sinai Health System - Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Clinique de Cardiologie de Lévis
Lévis, Quebec, G6V 4Z5, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, H4A 3J1, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
Québec, Quebec, G1V 4G5, Canada
CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
Saint-Georges, Quebec, G5Y 4T8, Canada
Recherche Medical St-Jerome Inc.
Saint-Jérôme, Quebec, J7Z 5T3, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec
Trois-Rivières, Quebec, G8Z 3R9, Canada
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Interni kardiologicka klinika FN Brno
Brno, 625 00, Czechia
Kardiologicka ambulance
Chlumec nad Cidlinou, 50353, Czechia
Centrum preventivní kardiologie, Karlovo nám. 32,
Prague, 128 08, Czechia
Centrum preventivní kardiologie
Prague, 128 08, Czechia
General University Hospital in Prague
Prague, 128 08, Czechia
General University Hospital
Prague, 128 08, Czechia
IKEM-Klinika kardiologie
Prague, 140 21, Czechia
JSC Evex Hospitals,Georgia
Batumi, 6010, Georgia
Clinic-LJ
Kutaisi, 4600, Georgia
Aleksandre Aladashvili Clinic LLC
Tbilisi, 0102, Georgia
Ltd Israel-Georgian Medical Research Clinic "Helsicore"
Tbilisi, 0112, Georgia
Ltd Pineo Medical Ecosistem
Tbilisi, 0114, Georgia
Acad. G. Chapidze Emergency Cardiology Center
Tbilisi, 0159, Georgia
Bokhua Memorial Cardiovascular Center
Tbilisi, 0159, Georgia
Tbilisi Heart and Vascular Clinic
Tbilisi, 0159, Georgia
Ltd TIM- Tbilisi Institute of Medicine
Tbilisi, 0160, Georgia
Georgian-Dutch Hospital
Tbilisi, 0172, Georgia
Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai
Budapest, 1085, Hungary
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Központ Kardiológiai Osztály
Debrecen, 4032, Hungary
Clinexpert Gyöngyös Kft
Gyöngyös, 3200, Hungary
Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház
Harkány, 7815, Hungary
Bács-Kiskun Megyei Kórház Kardiológiai Osztály
Kecskemét, 6000, Hungary
Andrea Hornyik, MD
Miskolc, 3529, Hungary
Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,
Pécs, 7624, Hungary
Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály
Szolnok, 5000, Hungary
Belvárosi Egészségház Kft
Zalaegerszeg, 8900, Hungary
Daugavpils Regional Hospital
Daugavpils, LV5417, Latvia
Liepajas Regional Hospital
Liepāja, LV3414, Latvia
Pauls Stradins Clinical University Hospital
Riga, LV1002, Latvia
Riga East University hospital clinic Gailezers
Riga, LV1038, Latvia
The Hospital of Lithuanian
Kaunas, 50161, Lithuania
Klaipeda Seaman's Hospital
Klaipėda, 92288, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661, Lithuania
Wellington Hospital
Newton, Wellington Region, 6021, New Zealand
Totara Clinical Research, Health New Lynn
Auckland, 0600, New Zealand
North Shore Hospital
Auckland, 0622, New Zealand
Auckland City Hospital
Auckland, 1023, New Zealand
Middlemore Hospital
Auckland, 2025, New Zealand
Christchurch Heart Institute
Christchurch, 8140, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
Hauora Tairāwhiti Department of Cardiology
Gisborne, 4010, New Zealand
Hawke's Bay Hospital
Hastings, 4120, New Zealand
Hutt Hospital
Lower Hutt, 5010, New Zealand
Nelson Hospital
Nelson, 7010, New Zealand
Taranaki Base Hospital
New Plymouth, 4310, New Zealand
Rotorua Hospital
Rotorua, New Zealand
Clinical Horizons NEW ZEALAND LTD
Tauranga, 3112, New Zealand
Oddział Kardiologii WSzS nr 4
Bytom, 41-902, Poland
Biokinetica S.A. Przychodnia Józefów
Józefów, 05-410, Poland
Centrum Medyczne Linden
Krakow, 30-394, Poland
Marcin Ogórek, MD, PhD
Lodz, 94-048, Poland
1 Wojskowy Szpital Klininiczny w Lublinie
Lublin, 20-049, Poland
Ko-Med Centra Kliniczne
Lublin, 20-362, Poland
Szpital Swietej Anny w Miechowie
Miechów, 32-200, Poland
Szpital Świętej Anny w Miechowie
Miechów, 32-200, Poland
Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna
Nowy Dwór Mazowiecki, 05-100, Poland
Zespol Opieki Zdrowotnej
Oława, 55-200, Poland
Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej
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Uniwersyteckie Centrum Kliniczne
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Centrum Medyczne K2J2
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Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
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4th Military Hospital
Wroclaw, 50-981, Poland
Proximum Centrum Usług Medycznych NZOZ
Wroclaw, 53-428, Poland
Municipal Autonomous Healthcare Institution "City Clinical Hospital #6
Chelyabinsk, 454017, Russia
Municipal Autonomous Healthcare Institution
Chelyabinsk, 454017, Russia
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
Kemerovo, 650002, Russia
State Budgetary Healthcare Institution of Moscow city "Moscow
Moscow, 117292, Russia
Private Medical Institution "Euromedservice
Pushkin, 196603, Russia
State Budgetary Institution of Ryazan Region
Ryazan, 390026, Russia
JSC Polyclinic Complex
Saint Petersburg, 190013, Russia
Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze
Saint Petersburg, 192242, Russia
Saint Petersburg Research Institute of Emergency Medicine
Saint Petersburg, 192242, Russia
LLC X7 Clinical Research
Saint Petersburg, 194156, Russia
Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital"
Saint Petersburg, 195257, Russia
LLC "Scientific Research Center Eco-Safety"
Saint Petersburg, 196143, Russia
State Healthcare Institution
Saratov, 410002, Russia
Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia
Saratov, 410054, Russia
Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"
Ivano-Frankivsk, 76025, Ukraine
Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department
Kharkiv, 61058, Ukraine
Scientific Medical Complex "University Clinic" of Kharkiv
Kharkiv, 61157, Ukraine
MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2
Kharkiv, 61176, Ukraine
Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council
Kryvyi Rih, 50031, Ukraine
Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv
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"Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City
Kyiv, 01601, Ukraine
Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv
Kyiv, 01601, Ukraine
Communal non-profit enterprise Kyiv City Clinical Hospital №1
Kyiv, 02091, Ukraine
Kyiv City Clinical Hospital of Emergency Aid,
Kyiv, 02166, Ukraine
Kyiv City Clinical Hospital of Emergency Aid
Kyiv, 02166, Ukraine
Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"
Kyiv, 03049, Ukraine
National Scientific Center Institute of Cardiology of M.D
Kyiv, 03680, Ukraine
State Institution "National Scientific Center "Institute of Cardiology
Kyiv, 03680, Ukraine
Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"
Kyiv, 04050, Ukraine
Medical Centre of LLC
Kyiv, 04050, Ukraine
MNPE "Lviv City Clinical Hospital No.5"
Lviv, 79000, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical
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Vinnytsia Regional Clinical Hospital of Veterans of War
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Vinnytsia, 21029, Ukraine
Communal Non-Profit Enterprise "City
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Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,
Zaporizhzhia, 69063, Ukraine
Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
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Communal Enterprise "Hospital №1" of Zhytomyr City Council
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Related Publications (5)
Lewis GD, Giczewska A, Mentz RJ, Butler J, Ezekowitz JA, De Pasquale C, O'Meara E, Troughton RW, Ponikowski P, Wong YW, Ikoma T, Malhotra R, Blackman N, Rockhold FW, Hernandez AF; HEART-FID Trial Investigators. Functional and Prognostic Implications of Different Iron Deficiency Definitions in Heart Failure: Insights From HEART-FID. JACC Heart Fail. 2025 Dec;13(12):102661. doi: 10.1016/j.jchf.2025.102661. Epub 2025 Oct 25.
PMID: 41137844DERIVEDHarrington J, Mentz RJ, Rockhold FW, Garg J, Butler J, De Pasquale CG, Ezekowitz JA, Lewis GD, O'Meara E, Ponikowski P, Troughton RW, Wong YW, Adamczyk R, Storie T, Blackman N, Hernandez AF. Hierarchical End Points in Prior Heart Failure Trials and the HEART-FID Trial. Circ Heart Fail. 2024 Feb;17(2):e010676. doi: 10.1161/CIRCHEARTFAILURE.123.010676. Epub 2024 Jan 22.
PMID: 38250799DERIVEDMentz RJ, Garg J, Rockhold FW, Butler J, De Pasquale CG, Ezekowitz JA, Lewis GD, O'Meara E, Ponikowski P, Troughton RW, Wong YW, She L, Harrington J, Adamczyk R, Blackman N, Hernandez AF; HEART-FID Investigators. Ferric Carboxymaltose in Heart Failure with Iron Deficiency. N Engl J Med. 2023 Sep 14;389(11):975-986. doi: 10.1056/NEJMoa2304968. Epub 2023 Aug 26.
PMID: 37632463DERIVEDHarrington J, Mentz RJ, Rockhold FW, Garg J, Butler J, De Pasquale CG, Ezekowitz JA, Lewis GD, O'Meara E, Ponikowski P, Troughton RW, Wong YW, Adamczyk R, Blackman N, Hernandez AF. Baseline characteristics of patients in the randomized study to investigate the efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency: HEART-FID trial. Am Heart J. 2023 Dec;266:25-31. doi: 10.1016/j.ahj.2023.08.005. Epub 2023 Aug 19.
PMID: 37598795DERIVEDMentz RJ, Ambrosy AP, Ezekowitz JA, Lewis GD, Butler J, Wong YW, De Pasquale CG, Troughton RW, O'Meara E, Rockhold FW, Garg J, Samsky MD, Leloudis D, Dugan M, Mundy LM, Hernandez AF; HEART-FID Trial Investigators. Randomized Placebo-Controlled Trial of Ferric Carboxymaltose in Heart Failure With Iron Deficiency: Rationale and Design. Circ Heart Fail. 2021 May;14(5):e008100. doi: 10.1161/CIRCHEARTFAILURE.120.008100. Epub 2021 May 18.
PMID: 34003690DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elizabeth Ernst, Global Executive Director of Regulatory Affairs
- Organization
- American Regent, Inc.
Study Officials
- STUDY CHAIR
Adrian F Hernandez, MD
Duke Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2017
First Posted
January 31, 2017
Study Start
March 15, 2017
Primary Completion
February 2, 2023
Study Completion
February 2, 2023
Last Updated
July 3, 2024
Results First Posted
July 3, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share