AzTrials
AzTrials

Heart FailurePhase 3HEART-FIDNCT03037931

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

A Phase 3 study testing Ferric Carboxymaltose in people with Heart Failure and Iron-deficiency, run by American Regent, Inc. at 345 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Iron-deficiency
What is being tested?
Ferric Carboxymaltose
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,065 participants
Where
345 sitesin 13 countries
Study dates
15 Mar 2017to 2 Feb 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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) .

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

345 sites in 13 countries.

345 sites in 13 countries

United States188 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Advanced Cardiovascular LLC

    Alexander City, Alabama, 35010

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • Amarillo Hearth Clinical Research Institute, Inc.

    Amarillo, Texas, 79106

  • PharmaTex Research

    Amarillo, Texas, 79106

  • Alaska Heart & Vascular Institute

    Anchorage, Alaska, 99508

  • Anne Arundel Health System Research Institute

    Annapolis, Maryland, 21401

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • Piedmont Heart Institute - Athens

    Athens, Georgia, 30606

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Advanced Cardiovascular, LLC

    Auburn, Alabama, 36830

  • University Cardiology Associates, LLC

    Augusta, Georgia, 30901

  • Augusta University

    Augusta, Georgia, 30912

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • Westside Medical Associates of Los Angeles

    Beverly Hills, California, 90211

  • Saint Luke's Boise Medical Center

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Cardiology Associates of South Florida

    Boynton Beach, Florida, 33472

  • Cardiovascular & Vein Center of Florida

    Bradenton, Florida, 34209

  • New York Presbyterian Brooklyn Methodist Hospital

    Brooklyn, New York, 11215

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Penn State Health Holy Spirit Medical Center Geisinger - Cardiology

    Camp Hill, Pennsylvania, 17011

  • Aultman Cardiology Clinical Trials

    Canton, Ohio, 44710

  • Harbor-UCLA Medical Center

    Carson, California, 90509

  • Trinity Medical WNY, PC

    Cheektowaga, New York, 14227

  • Mount Sinai Hospital Medical Center - Department of Cardiology

    Chicago, Illinois, 60608

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • The MetroHealth System

    Cleveland, Ohio, 44109

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Prisma Health

    Columbia, South Carolina, 29203

  • The Ohio State University

    Columbus, Ohio, 43210

  • Verde Valley Medical Center

    Cottonwood, Arizona, 86326

  • Valley Clinical Trials, Inc.

    Covina, California, 91723

  • 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

  • Danbury Hospital

    Danbury, Connecticut, 06810

  • Avail Clinical Research, LLC

    DeLand, Florida, 32720

  • Duke University Heart Failure Research

    Durham, North Carolina, 27710

  • Monmouth Cardiology Associates, LLC

    Eatontown, New Jersey, 07724

  • Riverside Clinical Research

    Edgewater, Florida, 32132

  • TriWest Research Associates, LLC

    El Cajon, California, 92020

  • North Ohio Heart Center

    Elyria, Ohio, 44035

  • Englewood Health

    Englewood, New Jersey, 07631

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201

  • Medicoricium, LLC

    Fairview Heights, Illinois, 62208

  • NECCR Prima Care Research, LLC

    Fall River, Massachusetts, 02721

  • Piedmont Heart Institute Fayetteville

    Fayetteville, Georgia, 30214

  • Advanced Heart & Vascular Institute of Hunterdon

    Flemington, New Jersey, 08822

  • Sparks Regional Medical Center

    Fort Smith, Arkansas, 72901

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • Texas Health Research & Education Institute

    Fort Worth, Texas, 76104

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Medication Management, LLC

    Greensboro, North Carolina, 27401

  • Self Regional Hospital Research Center

    Greenwood, South Carolina, 29646

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Heart Clinic of Hammond

    Hammond, Louisiana, 70403

  • Wake Forest University Health Sciences

    High Point, North Carolina, 27262

  • Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Texas Heart Institute

    Houston, Texas, 77030

  • California Heart Specialists

    Huntington Beach, California, 92648

  • Franciscan Physician Network - Indiana Heart Physicians

    Indianapolis, Indiana, 46237

  • St. Vincent Medical Group

    Indianapolis, Indiana, 46260

  • 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

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72401

  • Western Michigan University Homer Stryker M.D. School of Medicine

    Kalamazoo, Michigan, 49008

  • Houston Heart & Vascular Associates

    Kingwood, Texas, 77339

  • Tennova Healthcare-Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • First Valley Medical Group

    Lancaster, California, 93534

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Carolina Heart Specialists

    Lancaster, South Carolina, 29720

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Red Rock Clinical Research, LLC

    Las Vegas, Nevada, 89146

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • Healthcare Partners Affiliation Medical Group

    Long Beach, California, 90806

  • Axis Clinical Trials

    Los Angeles, California, 90036

  • Caprock Cardiac Center Research Institute, Inc.

    Lubbock, Texas, 79410

  • Angelina Medical Research, LLC

    Lufkin, Texas, 75904

  • Duke Cardiology of Lumberton

    Lumberton, North Carolina, 28358

  • Stroobants Cardiovascular Center

    Lynchburg, Virginia, 24501

  • Georgia Arrhythmia Consultants and Research Institute

    Macon, Georgia, 31201

  • Mercer University

    Macon, Georgia, 31201

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • North Dallas Research Associates

    McKinney, Texas, 75069

  • North Texas Research Associates

    McKinney, Texas, 75701

  • 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

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Allina Health System, dba Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Trinity Health Center - Medical Arts

    Minot, North Dakota, 58701

  • St. Joseph Heritage-Healthcare

    Mission Viejo, California, 92691

  • IMC/Diagnostic & Medical Clinic

    Mobile, Alabama, 36604

  • University of South Alabama

    Mobile, Alabama, 36617

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Crossroads Clinical Research, Inc.

    Mooresville, North Carolina, 28117

  • Indiana University Health Ball Memorial Hospital, Inc.

    Muncie, Indiana, 47303

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Tulane Heart & Vascular Institute

    New Orleans, Louisiana, 70112

  • Ochsner Health System

    New Orleans, Louisiana, 70121

  • Mount Sinai Hospital

    New York, New York, 10029

  • Christiana Care

    Newark, Delaware, 19718

  • Saint Michael's Medical Center

    Newark, New Jersey, 07102

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Radin Cardiovascular Medical Group, Inc.

    Newport Beach, California, 92663

  • Riverside Cardiology Specialists

    Newport News, Virginia, 23601

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Parkway Cardiology Associates, PC

    Oak Ridge, Tennessee, 37830

  • South Oklahoma Heart Research, LLC

    Oklahoma City, Oklahoma, 73135

  • CHI Health Research Center

    Omaha, Nebraska, 68124

  • Florida Hospital Transplant Institute

    Orlando, Florida, 32804

  • Cardiology Partners Clinical Research Institute

    Palm Beach Gardens, Florida, 33410

  • Springfield Medical Center

    Panama City, Florida, 32401

  • Pasadena Clinical Research

    Pasadena, California, 91105

  • 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

  • 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

  • Pinehurst Medical Clinic, Inc.

    Pinehurst, North Carolina, 28374

  • V.A. Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • Eugene Soroka, MD Inc.

    Port Hueneme, California, 93041

  • NC Heart & Vascular Research

    Raleigh, North Carolina, 27607

  • WakeMed Health and Hospitals

    Raleigh, North Carolina, 27610

  • Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.

    Rapid City, South Dakota, 57701

  • Reid Physician Associates / Reid Health

    Richmond, Indiana, 47374

  • Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)

    Richmond, Virginia, 23249

  • VCU Medical Center

    Richmond, Virginia, 23298

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Carilion Medical Center

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Rochester General Hospital

    Rochester, New York, 14621

  • Michigan CardioVascular Institute at Covenant Medical Center

    Saginaw, Michigan, 48602

  • South Texas Cardiovascular Consultants, PLLC

    San Antonio, Texas, 78201

  • VA San Diego Health Care System

    San Diego, California, 92161

  • North Ohio Heart Center

    Sandusky, Ohio, 44870

  • Maine Medical Partners Maine Health Cardiology

    Scarborough, Maine, 04074

  • Swedish Heart & Vascular-Advanced Cardiac Support Program

    Seattle, Washington, 98122

  • Louisiana Heart Center

    Slidell, Louisiana, 70458

  • Atlanta Vanguard Research Institute

    Smyrna, Georgia, 30082

  • Cardio Metabolic Institute

    Somerset, New Jersey, 08873

  • Beacon Medical Group Advanced Cardiovascular Specialists

    South Bend, Indiana, 46601

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington, 99204

  • Heart House Research Foundation

    Springfield, Ohio, 45505

  • St. Louis Heart & Vascular, PC

    St Louis, Missouri, 63136

  • Professional Health Care of Pinellas

    St. Petersburg, Florida, 33713

  • Stamford Hospital

    Stamford, Connecticut, 06904

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Stony Brook University Hospital

    Stony Brook, New York, 11794-7007

  • Clinical Research Institute of Arizona, LLC

    Surprise, Arizona, 85374

  • CHI Franciscan Research Center

    Tacoma, Washington, 98405

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Baylor Scott & White Medical Center

    Temple, Texas, 76508

  • Carondelet Heart and Vascular Institute - Cardiology East

    Tucson, Arizona, 85710

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi, 38801

  • PharmaTex Research

    Tyler, Texas, 75701

  • The University of Texas Health Center at Tyler

    Tyler, Texas, 75708

  • Indian River Medical Center

    Vero Beach, Florida, 32960

  • Walla Walla Clinic

    Walla Walla, Washington, 99362

  • ProHealth Care Inc / Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Cardiology Partners Clinical Research Institute

    Wellington, Florida, 33449

  • Wenatchee Valley Hospital & Clinics

    Wenatchee, Washington, 98801

  • Interventional Cardiology Medical Group

    West Hills, California, 91307

  • Advanced Clinical Research/Intermountain Heart Center PC

    West Jordan, Utah, 84088

  • Circuit Clinical

    West Seneca, New York, 14224

  • Wichita Falls Heart Clinic

    Wichita Falls, Texas, 76301

  • Northtowns Cardiology, PLLC

    Williamsville, New York, 14221

  • Alfieri Cardiology

    Wilmington, Delaware, 19803

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Selma Medical Associates

    Winchester, Virginia, 22601

Other trials in United States

Canada25 sites

  • Manna Research Inc., Burlington South

    Burlington, Ontario, L7R 1A4

  • University of Calbary

    Calgary, Alberta, T2N 4Z6

  • Cambridge Cardiac Care Center

    Cambridge, Ontario, N1R 6V6

  • Vizel Cardiac Research

    Cambridge, Ontario, N1R 7R1

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • South Edmonton Cardiology Consultants

    Edmonton, Alberta, T6L 6K3

  • Royal Alexandria Hospital

    Edmonton, Alberta

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 3A7

  • Clinique de Cardiologie de Lévis

    Lévis, Quebec, G6V 4Z5

  • London Health Sciences Center (LHSC)

    London, Ontario, N6A 5A5

  • G.A. Research Associates, Ltd.

    Moncton, New Brunswick

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A 3J1

  • Fraser Clinical Trials

    New Westminster, British Columbia, V3L 3W4

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval

    Québec, Quebec, G1V 4G5

  • CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges

    Saint-Georges, Quebec, G5Y 4T8

  • Recherche Medical St-Jerome Inc.

    Saint-Jérôme, Quebec, J7Z 5T3

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Health Sciences Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • SMH Cardiology Clinical Trials

    Surrey, British Columbia, V3V 0C6

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Sinai Health System - Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5

  • Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec

    Trois-Rivières, Quebec, G8Z 3R9

  • St. Paul's Hospital

    Vancouver, British Columbia, V6E 1M7

  • Victoria Heart Institute Foundation

    Victoria, British Columbia, V8R 4R2

Other trials in Canada

Ukraine24 sites

  • Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"

    Ivano-Frankivsk, 76025

  • Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department

    Kharkiv, 61058

  • Scientific Medical Complex "University Clinic" of Kharkiv

    Kharkiv, 61157

  • MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2

    Kharkiv, 61176

  • Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council

    Kryvyi Rih, 50031

  • Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv

    Kyiv, 01103

  • "Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City

    Kyiv, 01601

  • Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv

    Kyiv, 01601

  • Communal non-profit enterprise Kyiv City Clinical Hospital №1

    Kyiv, 02091

  • Kyiv City Clinical Hospital of Emergency Aid,

    Kyiv, 02166

  • Kyiv City Clinical Hospital of Emergency Aid

    Kyiv, 02166

  • Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"

    Kyiv, 03049

  • National Scientific Center Institute of Cardiology of M.D

    Kyiv, 03680

  • State Institution "National Scientific Center "Institute of Cardiology

    Kyiv, 03680

  • Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"

    Kyiv, 04050

  • Medical Centre of LLC

    Kyiv, 04050

  • MNPE "Lviv City Clinical Hospital No.5"

    Lviv, 79000

  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical

    Lviv, 79041

  • Vinnytsia Regional Clinical Hospital of Veterans of War

    Vinnytsia, 21005

  • "Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology"

    Vinnytsia, 21029

  • Communal Non-Profit Enterprise "City

    Zaporizhzhya, 69001

  • Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,

    Zaporizhzhya, 69063

  • Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,

    Zaporizhzhya, 69600

  • Communal Enterprise "Hospital №1" of Zhytomyr City Council

    Zhytomyr, 10002

Other trials in Ukraine

Australia16 sites

  • The Queen Elizabeth Hospital

    Adelaide, South Australia, 5011

  • Royal Adelaide Hospital

    Adelaide, 5000

  • SA Heart

    Ashford, South Australia, 5035

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575

  • Cairns Hospital

    Cairns, Queensland, 4870

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Heart Lung Clinic

    Darlinghurst, Sydney

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • SWSLHD-Liverpool Hospital

    Liverpool, New South Wales, 1871

  • Macquarie University - Clinical Trials Unit

    Macquarie Park, 2109

  • Core Research Group

    Milton, Queensland, 4064

  • John Hunter Hospital

    New Lambton Heights, 2305

  • Epworth HealthCare Clinical Trials

    Richmond, 3121

  • Gold Coast University Hospital

    Southport, Queensland, 4215

Other trials in Australia

Poland16 sites

  • Oddział Kardiologii WSzS nr 4

    Bytom, 41-902

  • Biokinetica S.A. Przychodnia Józefów

    Józefów, 05-410

  • Centrum Medyczne Linden

    Krakow, 30-394

  • Marcin Ogórek, MD, PhD

    Lodz, 94-048

  • 1 Wojskowy Szpital Klininiczny w Lublinie

    Lublin, 20-049

  • Ko-Med Centra Kliniczne

    Lublin, 20-362

  • Szpital Swietej Anny w Miechowie

    Miechów, 32-200

  • Szpital Świętej Anny w Miechowie

    Miechów, 32-200

  • Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna

    Nowy Dwór Mazowiecki, 05-100

  • Zespol Opieki Zdrowotnej

    Oława, 55-200

  • Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej

    Torun, 87-100

  • Uniwersyteckie Centrum Kliniczne

    Warsaw, 02-097

  • Centrum Medyczne K2J2

    Wołomin, 05-200

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

    Wroclaw, 50-556

  • 4th Military Hospital

    Wroclaw, 50-981

  • Proximum Centrum Usług Medycznych NZOZ

    Wroclaw, 53-428

Other trials in Poland

Bulgaria14 sites

  • MHAT Puls

    Blagoevgrad, 2700

  • Multiprofile Hospital for Active Treatment: Department of cardiology

    Gabrovo, 5300

  • MHAT Haskovo AD

    Haskovo, 6304

  • Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology

    Lom, 3600

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800

  • МC Hipokrena

    Sevlievo, 5400

  • Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology

    Sofia, 1113

  • Second Medical Center-Sofia, EEOD - Department of Cardiology

    Sofia, 1202

  • Second Multiprofile Hospital for Active Treatment

    Sofia, 1202

  • 5th City Hospital

    Sofia, 1233

  • National Multiprofile Transport Hospital Cardiology Clinic

    Sofia, 1233

  • Medical Center Hera EOOD - Office of Cardiology

    Sofia, 1510

  • Multiprofile Regional Hospital for Active Treatment

    Veliko Tarnovo, 5002

  • Medical Center Velingrad 2017" EOOD, Office of Cardiology

    Velingrad, 4600

Other trials in Bulgaria

New Zealand14 sites

  • Totara Clinical Research, Health New Lynn

    Auckland, 0600

  • North Shore Hospital

    Auckland, 0622

  • Auckland City Hospital

    Auckland, 1023

  • Middlemore Hospital

    Auckland, 2025

  • Christchurch Heart Institute

    Christchurch, 8140

  • Dunedin Hospital

    Dunedin, 9016

  • Hauora Tairāwhiti Department of Cardiology

    Gisborne, 4010

  • Hawke's Bay Hospital

    Hastings, 4120

  • Hutt Hospital

    Lower Hutt, 5010

  • Nelson Hospital

    Nelson, 7010

  • Taranaki Base Hospital

    New Plymouth, 4310

  • Wellington Hospital

    Newton, Wellington Region, 6021

  • Rotorua Hospital

    Rotorua

  • Clinical Horizons NEW ZEALAND LTD

    Tauranga, 3112

Other trials in New Zealand

Russia14 sites

  • Municipal Autonomous Healthcare Institution "City Clinical Hospital #6

    Chelyabinsk, 454017

  • Municipal Autonomous Healthcare Institution

    Chelyabinsk, 454017

  • Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases

    Kemerovo, 650002

  • State Budgetary Healthcare Institution of Moscow city "Moscow

    Moscow, 117292

  • Private Medical Institution "Euromedservice

    Pushkin, 196603

  • State Budgetary Institution of Ryazan Region

    Ryazan, 390026

  • JSC Polyclinic Complex

    Saint Petersburg, 190013

  • Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze

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About this study

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

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

Read the detailed description

This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) distance for patients in heart failure with iron deficiency.

After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment.

Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.

Being tested
Ferric Carboxymaltose, Placebo
Medical subject headings
Heart Failure, Anemia, Iron-Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric CarboxymaltoseDrug

    Also called Injectafer, Ferinject

    Intravenous Iron

  • PlaceboDrug

    Also called Saline solution

    Normal Saline Solution

Study groups in NCT03037931
Study groupRoleWhat they receive
Ferric CarboxymaltoseActive 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.
Receives: Drug: Ferric Carboxymaltose
PlaceboPlacebo comparatorNormal saline 15ml - 2 doses 7 days apart repeated every 6 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Deaths

    The number of participants who died out of the total treated group.

    Measured: 1 year

  2. Number of Hospitalizations for Heart Failure

    The number of participants who were hospitalized for heart failure out of the total treated group.

    Measured: 1 year

  3. Change in 6MWT (Six Minute Walk Test) Distance

    The change in meters walked at baseline compared to 6 months later.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2017 (estimated)
  2. Study start15 Mar 2017
  3. Primary completion2 Feb 2023
  4. Study completion2 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
3,065 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03037931
Sponsor's protocol ID
1VIT15043
Acronym
HEART-FID
Status last verified
Feb 2024
First submitted
25 Jan 2017
Last updated
3 Jul 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41137844

  • Ezekowitz JA, Mulder H, Mentz RJ, Butler J, DE Pasquale CG, Lewis GD, O'Meara E, Ponikowski P, Troughton RW, Wong YW, Adamczyk R, Numan S, Blackman N, Rockhold FW, Hernandez AF. Prediction and Longer-Term Outcomes of All-cause and Cardiovascular Mortality in the HEART-FID Trial. J Card Fail. 2025 Dec;31(12):1822-1833. doi: 10.1016/j.cardfail.2025.01.009. Epub 2025 Jan 29.

    PubMed 39890013

  • Harrington 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.

    PubMed 38250799

  • Mentz 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.

    PubMed 37632463

  • Harrington 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.

    PubMed 37598795

  • Mentz 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.

    PubMed 34003690

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferric Carboxymaltose in people with Heart Failure and Iron-deficiency, run by American Regent, Inc. at 345 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 345 sites in United States, Canada, Ukraine, Australia, Poland and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Deaths (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03037931, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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