Clinical trial NCT03037931: Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Iron-deficiency
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2017-01-31
Enrollment: 3065
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

1. Adult (≥18 years of age) able to provide signed, written informed consent.
2. 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.
3. Able and willing to perform a six-minute walk test (6MWT) at the time of randomization.
4. 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
5. Hemoglobin \>9.0 g/dL and \< 13.5 g/dL (females) or \<15.0 g/dL (males) within 28 days of randomization.
6. 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.
7. 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) .

Exclusion Criteria:

1. Known hypersensitivity reaction to any component of FCM.
2. History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
3. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment.
4. 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.
5. Current atrial fibrillation or atrial flutter with a mean ventricular response rate \>100 per minute (at rest).
6. Current or planned mechanical circulatory support or heart transplantation.
7. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
8. Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase \>3 times the upper limit of normal range).
9. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
10. Active gastrointestinal bleeding.
11. 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.
12. Inability to return for follow up visits within the necessary windows
13. Concurrently in a study with investigational product.
14. No participants with Current Coronavirus Disease-19 (COVID-19) Infection into the study.

Primary outcomes:
measure: Number of Deaths
timeFrame: 1 year
measure: Number of Hospitalizations for Heart Failure
timeFrame: 1 year
measure: Change in 6MWT (Six Minute Walk Test) Distance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Advanced Cardiovascular LLC
state: Alabama
city: Auburn
country: United States
facility: Advanced Cardiovascular, LLC
state: Alabama
city: Mobile
country: United States
facility: IMC/Diagnostic & Medical Clinic
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Heart & Vascular Institute
state: Alaska
city: Cottonwood
country: United States
facility: Verde Valley Medical Center
state: Arizona
city: Surprise
country: United States
facility: Clinical Research Institute of Arizona, LLC
state: Arizona
city: Tucson
country: United States
facility: Carondelet Heart and Vascular Institute - Cardiology East
state: Arizona
city: Fort Smith
country: United States
facility: Sparks Regional Medical Center
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Beverly Hills
country: United States
facility: Westside Medical Associates of Los Angeles
state: California
city: Carson
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Covina
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: El Cajon
country: United States
facility: TriWest Research Associates, LLC
state: California
city: Huntington Beach
country: United States
facility: California Heart Specialists
state: California
city: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Long Beach
country: United States
facility: Healthcare Partners Affiliation Medical Group
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Mission Viejo
country: United States
facility: St. Joseph Heritage-Healthcare
state: California
city: Newport Beach
country: United States
facility: Radin Cardiovascular Medical Group, Inc.
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Pasadena
country: United States
facility: Pasadena Clinical Research
state: California
city: Port Hueneme
country: United States
facility: Eugene Soroka, MD Inc.
state: California
city: San Diego
country: United States
facility: VA San Diego Health Care System
state: California
city: West Hills
country: United States
facility: Interventional Cardiology Medical Group
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Wilmington
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Boynton Beach
country: United States
facility: Cardiology Associates of South Florida
state: Florida
city: Bradenton
country: United States
facility: Cardiovascular & Vein Center of Florida
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Healthcare - Riverside
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Healthcare - Southside Recruiting
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami Lakes
country: United States
facility: Empire Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: ProLive Medical Research
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Miami
country: United States
facility: ITB Research
state: Florida
city: Miami
country: United States
facility: Vista Health Research
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Transplant Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Panama City
country: United States
facility: Springfield Medical Center
state: Florida
city: Pembroke Pines
country: United States
facility: Broward Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: South Florida Research Solutions, LLC
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants
state: Florida
city: Pensacola
country: United States
facility: Avanza Medical Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: Professional Health Care of Pinellas
state: Florida
city: Vero Beach
country: United States
facility: Indian River Medical Center
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Athens
country: United States
facility: Piedmont Heart Institute - Athens
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Augusta
country: United States
facility: University Cardiology Associates, LLC
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Fayetteville
country: United States
facility: Piedmont Heart Institute Fayetteville
state: Georgia
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants and Research Institute
state: Georgia
city: Macon
country: United States
facility: Mercer University
state: Georgia
city: Smyrna
country: United States
facility: Atlanta Vanguard Research Institute
state: Georgia
city: Boise
country: United States
facility: Saint Luke's Boise Medical Center
state: Idaho
city: Chicago
country: United States
facility: Mount Sinai Hospital Medical Center - Department of Cardiology
state: Illinois
city: Fairview Heights
country: United States
facility: Medicoricium, LLC
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan Physician Network - Indiana Heart Physicians
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group
state: Indiana
city: Muncie
country: United States
facility: Indiana University Health Ball Memorial Hospital, Inc.
state: Indiana
city: Richmond
country: United States
facility: Reid Physician Associates / Reid Health
state: Indiana
city: South Bend
country: United States
facility: Beacon Medical Group Advanced Cardiovascular Specialists
state: Indiana
city: Alexandria
country: United States
facility: Alexandria Cardiology Clinic
state: Louisiana
city: Hammond
country: United States
facility: Heart Clinic of Hammond
state: Louisiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Heart & Vascular Institute
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Slidell
country: United States
facility: Louisiana Heart Center
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Partners Maine Health Cardiology
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Health System Research Institute
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: NECCR Prima Care Research, LLC
state: Massachusetts
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University Homer Stryker M.D. School of Medicine
state: Michigan
city: Saginaw
country: United States
facility: Michigan CardioVascular Institute at Covenant Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Allina Health System, dba Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart & Vascular, PC
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Omaha
country: United States
facility: CHI Health Research Center
state: Nebraska
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Red Rock Clinical Research, LLC
state: Nevada
city: Eatontown
country: United States
facility: Monmouth Cardiology Associates, LLC
state: New Jersey
city: Englewood
country: United States
facility: Englewood Health
state: New Jersey
city: Flemington
country: United States
facility: Advanced Heart & Vascular Institute of Hunterdon
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Saint Peter's University Hospital
state: New Jersey
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Somerset
country: United States
facility: Cardio Metabolic Institute
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: New York Presbyterian Brooklyn Methodist Hospital
state: New York
city: Cheektowaga
country: United States
facility: Trinity Medical WNY, PC
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Staten Island
country: United States
facility: Richmond University Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: West Seneca
country: United States
facility: Circuit Clinical
state: New York
city: Williamsville
country: United States
facility: Northtowns Cardiology, PLLC
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Durham
country: United States
facility: Duke University Heart Failure Research
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: High Point
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Lumberton
country: United States
facility: Duke Cardiology of Lumberton
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Mooresville
country: United States
facility: Crossroads Clinical Research, Inc.
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic, Inc.
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart & Vascular Research
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed Health and Hospitals
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Minot
country: United States
facility: Trinity Health Center - Medical Arts
state: North Dakota
city: Canton
country: United States
facility: Aultman Cardiology Clinical Trials
state: Ohio
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Elyria
country: United States
facility: North Ohio Heart Center
state: Ohio
city: Sandusky
country: United States
facility: North Ohio Heart Center
state: Ohio
city: Springfield
country: United States
facility: Heart House Research Foundation
state: Ohio
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research, LLC
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: Camp Hill
country: United States
facility: Penn State Health Holy Spirit Medical Center Geisinger - Cardiology
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania - Perelman Center for Advanced Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: V.A. Pittsburgh Healthcare System
state: Pennsylvania
city: Columbia
country: United States
facility: Prisma Health
state: South Carolina
city: Greenwood
country: United States
facility: Self Regional Hospital Research Center
state: South Carolina
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.
state: South Dakota
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
city: Knoxville
country: United States
facility: Tennova Healthcare-Turkey Creek Medical Center
state: Tennessee
city: Oak Ridge
country: United States
facility: Parkway Cardiology Associates, PC
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Hearth Clinical Research Institute, Inc.
state: Texas
city: Amarillo
country: United States
facility: PharmaTex Research
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Dallas
country: United States
facility: Cardiovascular Research Institute of Dallas
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Research & Education Institute
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Kingwood
country: United States
facility: Houston Heart & Vascular Associates
state: Texas
city: Lubbock
country: United States
facility: Caprock Cardiac Center Research Institute, Inc.
state: Texas
city: Lufkin
country: United States
facility: Angelina Medical Research, LLC
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: McKinney
country: United States
facility: North Texas Research Associates
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants, PLLC
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center
state: Texas
city: Tyler
country: United States
facility: PharmaTex Research
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Center at Tyler
state: Texas
city: Wichita Falls
country: United States
facility: Wichita Falls Heart Clinic
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research/Intermountain Heart Center PC
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Lynchburg
country: United States
facility: Stroobants Cardiovascular Center
state: Virginia
city: Newport News
country: United States
facility: Riverside Cardiology Specialists
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Medical Center
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Seattle
country: United States
facility: Swedish Heart & Vascular-Advanced Cardiac Support Program
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center & Children's Hospital
state: Washington
city: Tacoma
country: United States
facility: CHI Franciscan Research Center
state: Washington
city: Walla Walla
country: United States
facility: Walla Walla Clinic
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Waukesha
country: United States
facility: ProHealth Care Inc / Waukesha Memorial Hospital
state: Wisconsin
city: Liverpool
country: Australia
facility: SWSLHD-Liverpool Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Cairns
country: Australia
facility: Cairns Hospital
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Milton
country: Australia
facility: Core Research Group
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Ashford
country: Australia
facility: SA Heart
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Darlinghurst
country: Australia
facility: Heart Lung Clinic
state: Sydney
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Macquarie Park
country: Australia
facility: Macquarie University - Clinical Trials Unit
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
city: Richmond
country: Australia
facility: Epworth HealthCare Clinical Trials
city: Blagoevgrad
country: Bulgaria
facility: MHAT Puls
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment: Department of cardiology
city: Haskovo
country: Bulgaria
facility: MHAT Haskovo AD
city: Lom
country: Bulgaria
facility: Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven OOD
city: Sevlievo
country: Bulgaria
facility: МC Hipokrena
city: Sofia
country: Bulgaria
facility: Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology
city: Sofia
country: Bulgaria
facility: Second Medical Center-Sofia, EEOD - Department of Cardiology
city: Sofia
country: Bulgaria
facility: Second Multiprofile Hospital for Active Treatment
city: Sofia
country: Bulgaria
facility: 5th City Hospital
city: Sofia
country: Bulgaria
facility: National Multiprofile Transport Hospital Cardiology Clinic
city: Sofia
country: Bulgaria
facility: Medical Center Hera EOOD - Office of Cardiology
city: Veliko Tarnovo
country: Bulgaria
facility: Multiprofile Regional Hospital for Active Treatment
city: Velingrad
country: Bulgaria
facility: Medical Center Velingrad 2017" EOOD, Office of Cardiology
city: Calgary
country: Canada
facility: University of Calbary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: South Edmonton Cardiology Consultants
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandria Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Clinical Trials
state: British Columbia
city: Surrey
country: Canada
facility: SMH Cardiology Clinical Trials
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Moncton
country: Canada
facility: G.A. Research Associates, Ltd.
state: New Brunswick
city: Saint John's
country: Canada
facility: Health Sciences Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
city: Burlington
country: Canada
facility: Manna Research Inc., Burlington South
state: Ontario
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Center
state: Ontario
city: Cambridge
country: Canada
facility: Vizel Cardiac Research
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center (LHSC)
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sinai Health System - Mount Sinai Hospital
state: Ontario
city: Lévis
country: Canada
facility: Clinique de Cardiologie de Lévis
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Québec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
state: Quebec
city: Saint-Georges
country: Canada
facility: CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
state: Quebec
city: Saint-Jérôme
country: Canada
facility: Recherche Medical St-Jerome Inc.
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Brno
country: Czechia
facility: Interni kardiologicka klinika FN Brno
city: Chlumec Nad Cidlinou
country: Czechia
facility: Kardiologicka ambulance
city: Prague
country: Czechia
facility: Centrum preventivní kardiologie, Karlovo nám. 32,
city: Prague
country: Czechia
facility: Centrum preventivní kardiologie
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Prague
country: Czechia
facility: General University Hospital
city: Prague
country: Czechia
facility: IKEM-Klinika kardiologie
city: Batumi
country: Georgia
facility: JSC Evex Hospitals,Georgia
city: Kutaisi
country: Georgia
facility: Clinic-LJ
city: Tbilisi
country: Georgia
facility: Aleksandre Aladashvili Clinic LLC
city: Tbilisi
country: Georgia
facility: Ltd Israel-Georgian Medical Research Clinic "Helsicore"
city: Tbilisi
country: Georgia
facility: Ltd Pineo Medical Ecosistem
city: Tbilisi
country: Georgia
facility: Acad. G. Chapidze Emergency Cardiology Center
city: Tbilisi
country: Georgia
facility: Bokhua Memorial Cardiovascular Center
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
city: Tbilisi
country: Georgia
facility: Ltd TIM- Tbilisi Institute of Medicine
city: Tbilisi
country: Georgia
facility: Georgian-Dutch Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ Kardiológiai Osztály
city: Gyöngyös
country: Hungary
facility: Clinexpert Gyöngyös Kft
city: Harkány
country: Hungary
facility: Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház
city: Kecskemet
country: Hungary
facility: Bács-Kiskun Megyei Kórház Kardiológiai Osztály
city: Miskolc
country: Hungary
facility: Andrea Hornyik, MD
city: Pecs
country: Hungary
facility: Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály
city: Zalaegerszeg
country: Hungary
facility: Belvárosi Egészségház Kft
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Liepaja
country: Latvia
facility: Liepajas Regional Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Riga
country: Latvia
facility: Riga East University hospital clinic Gailezers
city: Kaunas
country: Lithuania
facility: The Hospital of Lithuanian
city: Klaipėda
country: Lithuania
facility: Klaipeda Seaman's Hospital
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Newton
country: New Zealand
facility: Wellington Hospital
state: Wellington
city: Auckland
country: New Zealand
facility: Totara Clinical Research, Health New Lynn
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Heart Institute
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Gisborne
country: New Zealand
facility: Hauora Tairāwhiti Department of Cardiology
city: Hastings
country: New Zealand
facility: Hawke's Bay Hospital
city: Lower Hutt
country: New Zealand
facility: Hutt Hospital
city: Nelson
country: New Zealand
facility: Nelson Hospital
city: New Plymouth
country: New Zealand
facility: Taranaki Base Hospital
city: Rotorua
country: New Zealand
facility: Rotorua Hospital
city: Tauranga
country: New Zealand
facility: Clinical Horizons NEW ZEALAND LTD
city: Bytom
country: Poland
facility: Oddział Kardiologii WSzS nr 4
city: Józefów
country: Poland
facility: Biokinetica S.A. Przychodnia Józefów
city: Kraków
country: Poland
facility: Centrum Medyczne Linden
city: Lublin
country: Poland
facility: 1 Wojskowy Szpital Klininiczny w Lublinie
city: Lublin
country: Poland
facility: Ko-Med Centra Kliniczne
city: Miechów
country: Poland
facility: Szpital Swietej Anny w Miechowie
city: Miechów
country: Poland
facility: Szpital Świętej Anny w Miechowie
city: Nowy Dwór Mazowiecki
country: Poland
facility: Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna
city: Oława
country: Poland
facility: Zespol Opieki Zdrowotnej
city: Toruń
country: Poland
facility: Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Wołomin
country: Poland
facility: Centrum Medyczne K2J2
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
city: Wrocław
country: Poland
facility: 4th Military Hospital
city: Wrocław
country: Poland
facility: Proximum Centrum Usług Medycznych NZOZ
city: Łódź
country: Poland
facility: Marcin Ogórek, MD, PhD
city: Chelyabinsk
country: Russian Federation
facility: Municipal Autonomous Healthcare Institution "City Clinical Hospital #6
city: Chelyabinsk
country: Russian Federation
facility: Municipal Autonomous Healthcare Institution
city: Kemerovo
country: Russian Federation
facility: Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow city "Moscow
city: Pushkin
country: Russian Federation
facility: Private Medical Institution "Euromedservice
city: Ryazan
country: Russian Federation
facility: State Budgetary Institution of Ryazan Region
city: Saint Petersburg
country: Russian Federation
facility: JSC Polyclinic Complex
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital"
city: Saint Petersburg
country: Russian Federation
facility: LLC "Scientific Research Center Eco-Safety"
city: Saint-Petersburg
country: Russian Federation
facility: JSC Polyclinic Complex
city: Saratov
country: Russian Federation
facility: State Healthcare Institution
city: Saratov
country: Russian Federation
facility: Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia
city: St. Petersburg
country: Russian Federation
facility: Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze
city: St. Petersburg
country: Russian Federation
facility: Saint Petersburg Research Institute of Emergency Medicine
city: St. Petersburg
country: Russian Federation
facility: LLC X7 Clinical Research
city: Ivano-Frankivs'k
country: Ukraine
facility: Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"
city: Kharkiv
country: Ukraine
facility: Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department
city: Kharkiv
country: Ukraine
facility: Scientific Medical Complex "University Clinic" of Kharkiv
city: Kharkiv
country: Ukraine
facility: MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2
city: Kryvyi Rih
country: Ukraine
facility: Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council
city: Kyiv,
country: Ukraine
facility: "Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City
city: Kyiv
country: Ukraine
facility: Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv
city: Kyiv
country: Ukraine
facility: Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv
city: Kyiv
country: Ukraine
facility: Communal non-profit enterprise Kyiv City Clinical Hospital №1
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital of Emergency Aid,
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital of Emergency Aid
city: Kyiv
country: Ukraine
facility: Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"
city: Kyiv
country: Ukraine
facility: National Scientific Center Institute of Cardiology of M.D
city: Kyiv
country: Ukraine
facility: State Institution "National Scientific Center "Institute of Cardiology
city: Kyiv
country: Ukraine
facility: Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"
city: Kyiv
country: Ukraine
facility: Medical Centre of LLC
city: Lviv
country: Ukraine
facility: MNPE "Lviv City Clinical Hospital No.5"
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital of Veterans of War
city: Vinnytsia
country: Ukraine
facility: "Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology"
city: Zaporizhzhia
country: Ukraine
facility: Communal Non-Profit Enterprise "City
city: Zaporizhzhia
country: Ukraine
facility: Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,
city: Zaporizhzhia
country: Ukraine
facility: Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
city: Zhytomyr
country: Ukraine
facility: Communal Enterprise "Hospital №1" of Zhytomyr City Council
Study officials:
affiliation: Duke Clinical Research Institute
name: Adrian F Hernandez, MD
role: STUDY_CHAIR
References:
citation: 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.