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

PHASE3CompletedINTERVENTIONAL
Enrollment

3,065

Participants

Timeline

Start Date

March 15, 2017

Primary Completion Date

February 2, 2023

Study Completion Date

February 2, 2023

Conditions
Heart FailureIron-deficiency
Interventions
DRUG

Ferric Carboxymaltose

Intravenous Iron

DRUG

Placebo

Normal Saline Solution

Trial Locations (345)

1023

Auckland City Hospital, Auckland

1085

Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai, Budapest

1113

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

1122

Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika, Budapest

1202

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

Second Multiprofile Hospital for Active Treatment, Sofia

1233

5th City Hospital, Sofia

National Multiprofile Transport Hospital Cardiology Clinic, Sofia

1510

Medical Center Hera EOOD - Office of Cardiology, Sofia

1871

SWSLHD-Liverpool Hospital, Liverpool

2025

Middlemore Hospital, Auckland

2109

Macquarie University - Clinical Trials Unit, Macquarie Park

2305

John Hunter Hospital, New Lambton Heights

2700

MHAT Puls, Blagoevgrad

3112

Clinical Horizons NEW ZEALAND LTD, Tauranga

3121

Epworth HealthCare Clinical Trials, Richmond

3200

Clinexpert Gyöngyös Kft, Gyöngyös

3529

Andrea Hornyik, MD, Miskolc

3600

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

4010

Hauora Tairāwhiti Department of Cardiology, Gisborne

4032

The Prince Charles Hospital, Chermside

Debreceni Egyetem Klinikai Központ Kardiológiai Osztály, Debrecen

4064

Core Research Group, Milton

4120

Hawke's Bay Hospital, Hastings

4215

Gold Coast University Hospital, Southport

4310

Taranaki Base Hospital, New Plymouth

4575

Sunshine Coast University Hospital, Birtinya

4600

"Medical Center Velingrad 2017 EOOD, Office of Cardiology", Velingrad

Clinic-LJ, Kutaisi

4870

Cairns Hospital, Cairns

5000

Royal Adelaide Hospital, Adelaide

Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály, Szolnok

5002

Multiprofile Regional Hospital for Active Treatment, Veliko Tarnovo

5010

Hutt Hospital, Lower Hutt

5011

The Queen Elizabeth Hospital, Adelaide

5035

SA Heart, Ashford

5042

Flinders Medical Centre, Bedford Park

5112

Lyell McEwin Hospital, Elizabeth Vale

5300

Multiprofile Hospital for Active Treatment: Department of cardiology, Gabrovo

5400

МC Hipokrena, Sevlievo

5800

Medical Center Medconsult Pleven OOD, Pleven

6000

Bács-Kiskun Megyei Kórház Kardiológiai Osztály, Kecskemét

6010

JSC Evex Hospitals,Georgia, Batumi

6021

Wellington Hospital, Newton

6304

MHAT Haskovo AD, Haskovo

7000

Royal Hobart Hospital, Hobart

7010

Nelson Hospital, Nelson

7624

Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,, Pécs

7815

Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház, Harkány

8140

Christchurch Heart Institute, Christchurch

8900

Belvárosi Egészségház Kft, Zalaegerszeg

9016

Dunedin Hospital, Dunedin

10002

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

10029

Mount Sinai Hospital, New York

10310

Richmond University Medical Center, Staten Island

11215

New York Presbyterian Brooklyn Methodist Hospital, Brooklyn

14221

Northtowns Cardiology, PLLC, Williamsville

14224

Circuit Clinical, West Seneca

14227

Trinity Medical WNY, PC, Cheektowaga

14621

Rochester General Hospital, Rochester

15240

V.A. Pittsburgh Healthcare System, Pittsburgh

17011

Penn State Health Holy Spirit Medical Center Geisinger - Cardiology, Camp Hill

17602

Lancaster General Hospital, Lancaster

19001

Abington Memorial Hospital, Abington

19102

Drexel University, Philadelphia

19104

Hospital of the University of Pennsylvania, Philadelphia

University of Pennsylvania - Perelman Center for Advanced Medicine, Philadelphia

19718

Christiana Care, Newark

19803

Alfieri Cardiology, Wilmington

20814

Suburban Hospital, Bethesda

21005

Vinnytsia Regional Clinical Hospital of Veterans of War, Vinnytsia

21029

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

21215

Sinai Hospital of Baltimore, Baltimore

21401

Anne Arundel Health System Research Institute, Annapolis

22601

Selma Medical Associates, Winchester

23249

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

23298

VCU Medical Center, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

23601

Riverside Cardiology Specialists, Newport News

24014

Carilion Medical Center, Roanoke

24501

Stroobants Cardiovascular Center, Lynchburg

27262

Wake Forest University Health Sciences, High Point

27401

Medication Management, LLC, Greensboro

27607

NC Heart & Vascular Research, Raleigh

27610

WakeMed Health and Hospitals, Raleigh

27710

Duke University Heart Failure Research, Durham

28112

Monroe Biomedical Research, Monroe

28117

Crossroads Clinical Research, Inc., Mooresville

28358

Duke Cardiology of Lumberton, Lumberton

28374

Pinehurst Medical Clinic, Inc., Pinehurst

28401

PMG Research of Wilmington, Wilmington

28803

Asheville Cardiology Associates, Asheville

29203

Prisma Health, Columbia

29646

Self Regional Hospital Research Center, Greenwood

29720

Carolina Heart Specialists, Lancaster

30082

Atlanta Vanguard Research Institute, Smyrna

30214

Piedmont Heart Institute Fayetteville, Fayetteville

30309

Piedmont Heart Institute, Atlanta

30606

Piedmont Heart Institute - Athens, Athens

30901

University Cardiology Associates, LLC, Augusta

30912

Augusta University, Augusta

31201

Georgia Arrhythmia Consultants and Research Institute, Macon

Mercer University, Macon

32132

Riverside Clinical Research, Edgewater

32204

St. Vincent's Healthcare - Riverside, Jacksonville

32209

UF Health Jacksonville, Jacksonville

32216

St. Vincent's Healthcare - Southside Recruiting, Jacksonville

32224

Mayo Clinic Florida, Jacksonville

32401

Springfield Medical Center, Panama City

32501

Cardiology Consultants, Pensacola

32503

Avanza Medical Research Center, Pensacola

32720

Avail Clinical Research, LLC, DeLand

32804

Florida Hospital Transplant Institute, Orlando

32960

Indian River Medical Center, Vero Beach

33016

Empire Clinical Research, LLC, Miami Lakes

33021

Memorial Regional Hospital, Hollywood

33024

Broward Research Center, Pembroke Pines

33026

South Florida Research Solutions, LLC, Pembroke Pines

33130

ProLive Medical Research, Miami

33155

Cordova Research Institute, LLC, Miami

33165

Med-Care Research, Miami

33173

ITB Research, Miami

33176

Vista Health Research, Miami

33410

Cardiology Partners Clinical Research Institute, Palm Beach Gardens

33449

Cardiology Partners Clinical Research Institute, Wellington

33472

Cardiology Associates of South Florida, Boynton Beach

33713

Professional Health Care of Pinellas, St. Petersburg

33756

Innovative Research of West Florida, Inc., Clearwater

34209

Cardiovascular & Vein Center of Florida, Bradenton

35010

Advanced Cardiovascular LLC, Alexander City

36604

IMC/Diagnostic & Medical Clinic, Mobile

36617

University of South Alabama, Mobile

36830

Advanced Cardiovascular, LLC, Auburn

37830

Parkway Cardiology Associates, PC, Oak Ridge

37934

Tennova Healthcare-Turkey Creek Medical Center, Knoxville

38138

Stern Cardiovascular Foundation, Germantown

38801

Cardiology Associates Research, LLC, Tupelo

43210

The Ohio State University, Columbus

44035

North Ohio Heart Center, Elyria

44109

The MetroHealth System, Cleveland

44195

The Cleveland Clinic Foundation, Cleveland

44710

Aultman Cardiology Clinical Trials, Canton

44870

North Ohio Heart Center, Sandusky

45505

Heart House Research Foundation, Springfield

46237

Franciscan Physician Network - Indiana Heart Physicians, Indianapolis

46260

St. Vincent Medical Group, Indianapolis

46601

Beacon Medical Group Advanced Cardiovascular Specialists, South Bend

46845

Parkview Research Center, Fort Wayne

47303

Indiana University Health Ball Memorial Hospital, Inc., Muncie

47374

Reid Physician Associates / Reid Health, Richmond

48439

Genesys Regional Medical Center, Grand Blanc

48602

Michigan CardioVascular Institute at Covenant Medical Center, Saginaw

49008

Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo

50031

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

50161

The Hospital of Lithuanian, Kaunas

50353

Kardiologicka ambulance, Chlumec nad Cidlinou

53188

ProHealth Care Inc / Waukesha Memorial Hospital, Waukesha

53226

Medical College of Wisconsin, Milwaukee

54449

Marshfield Clinic, Marshfield

55407

Allina Health System, dba Abbott Northwestern Hospital, Minneapolis

55905

Mayo Clinic, Rochester

57701

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

58701

Trinity Health Center - Medical Arts, Minot

60608

Mount Sinai Hospital Medical Center - Department of Cardiology, Chicago

61058

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

61157

"Scientific Medical Complex University Clinic of Kharkiv", Kharkiv

61176

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

62208

Medicoricium, LLC, Fairview Heights

63136

St. Louis Heart & Vascular, PC, St Louis

64116

North Kansas City Hospital, North Kansas City

68124

CHI Health Research Center, Omaha

68526

Nebraska Heart Institute, Lincoln

69001

"Communal Non-Profit Enterprise City", Zaporizhzhia

69063

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

69600

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

70112

Tulane Heart & Vascular Institute, New Orleans

70121

Ochsner Health System, New Orleans

70360

Cardiovascular Institute of the South, Houma

70403

Heart Clinic of Hammond, Hammond

70458

Louisiana Heart Center, Slidell

71301

Alexandria Cardiology Clinic, Alexandria

72211

Arkansas Heart Hospital, Little Rock

72401

NEA Baptist Clinic, Jonesboro

72901

Sparks Regional Medical Center, Fort Smith

73135

South Oklahoma Heart Research, LLC, Oklahoma City

75069

North Dallas Research Associates, McKinney

75216

Dallas VA Medical Center, Dallas

75231

Cardiovascular Research Institute of Dallas, Dallas

75235

Southwest Family Medicine Associates, Dallas

75246

Baylor University Medical Center, Dallas

75701

North Texas Research Associates, McKinney

PharmaTex Research, Tyler

75708

The University of Texas Health Center at Tyler, Tyler

75904

Angelina Medical Research, LLC, Lufkin

76025

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

76104

Texas Health Research & Education Institute, Fort Worth

76301

Wichita Falls Heart Clinic, Wichita Falls

76508

Baylor Scott & White Medical Center, Temple

77030

Texas Heart Institute, Houston

77339

Houston Heart & Vascular Associates, Kingwood

78201

South Texas Cardiovascular Consultants, PLLC, San Antonio

79000

"MNPE Lviv City Clinical Hospital No.5", Lviv

79041

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

79106

Amarillo Hearth Clinical Research Institute, Inc., Amarillo

PharmaTex Research, Amarillo

79410

Caprock Cardiac Center Research Institute, Inc., Lubbock

80120

South Denver Cardiology Associates, PC, Littleton

83712

Saint Luke's Boise Medical Center, Boise

84088

Advanced Clinical Research/Intermountain Heart Center PC, West Jordan

85374

Clinical Research Institute of Arizona, LLC, Surprise

85710

Carondelet Heart and Vascular Institute - Cardiology East, Tucson

86326

Verde Valley Medical Center, Cottonwood

89102

University Medical Center of Southern Nevada, Las Vegas

89146

Red Rock Clinical Research, LLC, Las Vegas

90036

Axis Clinical Trials, Los Angeles

90211

Westside Medical Associates of Los Angeles, Beverly Hills

90509

Harbor-UCLA Medical Center, Carson

90806

Healthcare Partners Affiliation Medical Group, Long Beach

91105

Pasadena Clinical Research, Pasadena

91307

Interventional Cardiology Medical Group, West Hills

91325

Valley Clinical Trials, Inc., Northridge

91723

Valley Clinical Trials, Inc., Covina

92020

TriWest Research Associates, LLC, El Cajon

92161

VA San Diego Health Care System, San Diego

92288

Klaipeda Seaman's Hospital, Klaipėda

92648

California Heart Specialists, Huntington Beach

92663

Radin Cardiovascular Medical Group, Inc., Newport Beach

92691

St. Joseph Heritage-Healthcare, Mission Viejo

93041

Eugene Soroka, MD Inc., Port Hueneme

93534

First Valley Medical Group, Lancaster

98122

Swedish Heart & Vascular-Advanced Cardiac Support Program, Seattle

98201

Providence Regional Medical Center Everett, Everett

98405

CHI Franciscan Research Center, Tacoma

98801

Wenatchee Valley Hospital & Clinics, Wenatchee

99204

Providence Sacred Heart Medical Center & Children's Hospital, Spokane

99362

Walla Walla Clinic, Walla Walla

99508

Alaska Heart & Vascular Institute, Anchorage

117292

"State Budgetary Healthcare Institution of Moscow city Moscow", Moscow

190013

JSC Polyclinic Complex, Saint Petersburg

192242

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

Saint Petersburg Research Institute of Emergency Medicine, Saint Petersburg

194156

LLC X7 Clinical Research, Saint Petersburg

195257

"Saint-Petersburg State Budgetary Institution of Healthcare Saint Martyr Elizabeth city hospital", Saint Petersburg

196143

"LLC Scientific Research Center Eco-Safety", Saint Petersburg

196603

"Private Medical Institution Euromedservice", Pushkin

390026

State Budgetary Institution of Ryazan Region, Ryazan

410002

State Healthcare Institution, Saratov

410054

Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia, Saratov

454017

"Municipal Autonomous Healthcare Institution City Clinical Hospital #6", Chelyabinsk

Municipal Autonomous Healthcare Institution, Chelyabinsk

650002

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

06810

Danbury Hospital, Danbury

06904

Stamford Hospital, Stamford

04074

Maine Medical Partners Maine Health Cardiology, Scarborough

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

02721

NECCR Prima Care Research, LLC, Fall River

07724

Monmouth Cardiology Associates, LLC, Eatontown

07631

Englewood Health, Englewood

08822

Advanced Heart & Vascular Institute of Hunterdon, Flemington

07601

Hackensack University Medical Center, Hackensack

08901

Saint Peter's University Hospital, New Brunswick

07102

Saint Michael's Medical Center, Newark

07103

Rutgers New Jersey Medical School, Newark

08240

AtlantiCare Regional Medical Center, Pomona

07450

The Valley Hospital, Ridgewood

08873

Cardio Metabolic Institute, Somerset

07666

Holy Name Medical Center, Teaneck

11794-7007

Stony Brook University Hospital, Stony Brook

05401

The University of Vermont Medical Center, Burlington

Unknown

Heart Lung Clinic, Darlinghurst

Royal Alexandria Hospital, Edmonton

G.A. Research Associates, Ltd., Moncton

Rotorua Hospital, Rotorua

T2N 4Z6

University of Calbary, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

T6L 6K3

South Edmonton Cardiology Consultants, Edmonton

V3L 3W4

Fraser Clinical Trials, New Westminster

V3V 0C6

SMH Cardiology Clinical Trials, Surrey

V6E 1M7

St. Paul's Hospital, Vancouver

V8R 4R2

Victoria Heart Institute Foundation, Victoria

A1B 3V6

Health Sciences Centre, St. John's

B3H 3A7

Nova Scotia Health Authority, Halifax

L7R 1A4

Manna Research Inc., Burlington South, Burlington

N1R 6V6

Cambridge Cardiac Care Center, Cambridge

N1R 7R1

Vizel Cardiac Research, Cambridge

N6A 5A5

London Health Sciences Center (LHSC), London

M5B 1W8

St. Michael's Hospital, Toronto

M5G 1X5

Sinai Health System - Mount Sinai Hospital, Toronto

G6V 4Z5

Clinique de Cardiologie de Lévis, Lévis

H1T 1C8

Montreal Heart Institute, Montreal

H4A 3J1

McGill University Health Centre (MUHC), Montreal

G1V 4G5

Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval, Québec

G5Y 4T8

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

J7Z 5T3

Recherche Medical St-Jerome Inc., Saint-Jérôme

G8Z 3R9

Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec, Trois-Rivières

S7N 0W8

Royal University Hospital, Saskatoon

625 00

Interni kardiologicka klinika FN Brno, Brno

128 08

Centrum preventivní kardiologie, Karlovo nám. 32,, Prague

Centrum preventivní kardiologie, Prague

General University Hospital in Prague, Prague

General University Hospital, Prague

140 21

IKEM-Klinika kardiologie, Prague

0102

Aleksandre Aladashvili Clinic LLC, Tbilisi

0112

"Ltd Israel-Georgian Medical Research Clinic Helsicore", Tbilisi

0114

Ltd Pineo Medical Ecosistem, Tbilisi

0159

Acad. G. Chapidze Emergency Cardiology Center, Tbilisi

Bokhua Memorial Cardiovascular Center, Tbilisi

Tbilisi Heart and Vascular Clinic, Tbilisi

0160

Ltd TIM- Tbilisi Institute of Medicine, Tbilisi

0172

Georgian-Dutch Hospital, Tbilisi

LV5417

Daugavpils Regional Hospital, Daugavpils

LV3414

Liepajas Regional Hospital, Liepāja

LV1002

Pauls Stradins Clinical University Hospital, Riga

LV1038

Riga East University hospital clinic Gailezers, Riga

08661

Vilnius University Hospital Santaros Klinikos, Vilnius

0600

Totara Clinical Research, Health New Lynn, Auckland

0622

North Shore Hospital, Auckland

41-902

Oddział Kardiologii WSzS nr 4, Bytom

05-410

Biokinetica S.A. Przychodnia Józefów, Józefów

30-394

Centrum Medyczne Linden, Krakow

94-048

Marcin Ogórek, MD, PhD, Lodz

20-049

1 Wojskowy Szpital Klininiczny w Lublinie, Lublin

20-362

Ko-Med Centra Kliniczne, Lublin

32-200

Szpital Swietej Anny w Miechowie, Miechów

Szpital Świętej Anny w Miechowie, Miechów

05-100

Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna, Nowy Dwór Mazowiecki

55-200

Zespol Opieki Zdrowotnej, Oława

87-100

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

02-097

Uniwersyteckie Centrum Kliniczne, Warsaw

05-200

Centrum Medyczne K2J2, Wołomin

50-556

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Wroclaw

50-981

4th Military Hospital, Wroclaw

53-428

Proximum Centrum Usług Medycznych NZOZ, Wroclaw

01103

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

01601

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

"Communal nonprofit enterprise Oleksandrivska Clinical Hospital of Kyiv", Kyiv

02091

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

02166

Kyiv City Clinical Hospital of Emergency Aid,, Kyiv

Kyiv City Clinical Hospital of Emergency Aid, Kyiv

03049

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

03680

National Scientific Center Institute of Cardiology of M.D, Kyiv

"State Institution National Scientific Center Institute of Cardiology", Kyiv

04050

"Medical Centre of LLC Medical Centre CONSILIUM MEDICAL", Kyiv

Medical Centre of LLC, Kyiv

Sponsors
All Listed Sponsors
collaborator

Duke Clinical Research Institute

OTHER

lead

American Regent, Inc.

INDUSTRY