Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
- Conditions
- Iron-deficiencyHeart Failure
- Interventions
- Drug: Placebo
- Registration Number
- NCT03037931
- Lead Sponsor
- American Regent, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3065
-
Adult (≥18 years of age) able to provide signed, written informed consent.
-
Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization.
-
Able and willing to perform a six-minute walk test (6MWT) at the time of randomization.
-
Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG), valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation.
a. Left ventricular ejection fraction ≤ 40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction ≤ 40% within 24 months of screening visit ii. Historical value of ejection fraction ≤ 30% within 36 months of screening visit
-
Hemoglobin >9.0 g/dL and < 13.5 g/dL (females) or <15.0 g/dL (males) within 28 days of randomization.
-
Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.Patients with screening ferritin <15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization.
-
Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) > 600 pg/mL (or BNP >200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL) .
- Known hypersensitivity reaction to any component of FCM.
- History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
- Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment.
- Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention.
- Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest).
- Current or planned mechanical circulatory support or heart transplantation.
- Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
- Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
- Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
- Active gastrointestinal bleeding.
- Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
- Inability to return for follow up visits within the necessary windows
- Concurrently in a study with investigational product.
- No participants with Current Coronavirus Disease-19 (COVID-19) Infection into the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Normal saline 15ml - 2 doses 7 days apart repeated every 6 months. Ferric Carboxymaltose Ferric Carboxymaltose Ferric 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.
- Primary Outcome Measures
Name Time Method Number of Deaths 1 year The number of participants who died out of the total treated group.
Number of Hospitalizations for Heart Failure 1 year The number of participants who were hospitalized for heart failure out of the total treated group.
Change in 6MWT (Six Minute Walk Test) Distance 6 months The change in meters walked at baseline compared to 6 months later.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (341)
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Richmond University Medical Center
🇺🇸Staten Island, New York, United States
SWSLHD-Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Cardiovascular Research Institute of Dallas
🇺🇸Dallas, Texas, United States
University of Pennsylvania - Perelman Center for Advanced Medicine
🇺🇸Philadelphia, Pennsylvania, United States
V.A. Pittsburgh Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
The MetroHealth System
🇺🇸Cleveland, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Vista Health Research
🇺🇸Miami, Florida, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Red Rock Clinical Research, LLC
🇺🇸Las Vegas, Nevada, United States
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Tbilisi Heart and Vascular Clinic
🇬🇪Tbilisi, Georgia
Liepajas Regional Hospital
🇱🇻Liepaja, Latvia
Riga East University hospital clinic Gailezers
🇱🇻Riga, Latvia
Vilnius University Hospital Santaros Klinikos
🇱🇹Vilnius, Lithuania
Kyiv City Clinical Hospital of Emergency Aid
🇺🇦Kyiv, Ukraine
Medical Centre of LLC
🇺🇦Kyiv, Ukraine
MNPE "Lviv City Clinical Hospital No.5"
🇺🇦Lviv, Ukraine
Communal Non-Profit Enterprise "City
🇺🇦Zaporizhzhia, Ukraine
G.A. Research Associates, Ltd.
🇨🇦Moncton, New Brunswick, Canada
VA San Diego Health Care System
🇺🇸San Diego, California, United States
Allina Health System, dba Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Duke University Heart Failure Research
🇺🇸Durham, North Carolina, United States
South Oklahoma Heart Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Calbary
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
South Edmonton Cardiology Consultants
🇨🇦Edmonton, Alberta, Canada
Royal Alexandria Hospital
🇨🇦Edmonton, Alberta, Canada
London Health Sciences Center (LHSC)
🇨🇦London, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Clinique de Cardiologie de Lévis
🇨🇦Lévis, Quebec, Canada
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
🇨🇦Québec, Quebec, Canada
Recherche Medical St-Jerome Inc.
🇨🇦Saint-Jérôme, Quebec, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-et-du-centre-du-Quebec
🇨🇦Trois-Rivières, Quebec, Canada
Advanced Cardiovascular LLC
🇺🇸Alexander City, Alabama, United States
IMC/Diagnostic & Medical Clinic
🇺🇸Mobile, Alabama, United States
Verde Valley Medical Center
🇺🇸Cottonwood, Arizona, United States
Alaska Heart & Vascular Institute
🇺🇸Anchorage, Alaska, United States
Pasadena Clinical Research
🇺🇸Pasadena, California, United States
Clinical Research Institute of Arizona, LLC
🇺🇸Surprise, Arizona, United States
St. Joseph Heritage-Healthcare
🇺🇸Mission Viejo, California, United States
Sparks Regional Medical Center
🇺🇸Fort Smith, Arkansas, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
TriWest Research Associates, LLC
🇺🇸El Cajon, California, United States
First Valley Medical Group
🇺🇸Lancaster, California, United States
Radin Cardiovascular Medical Group, Inc.
🇺🇸Newport Beach, California, United States
St. Vincent's Healthcare - Riverside
🇺🇸Jacksonville, Florida, United States
Alfieri Cardiology
🇺🇸Wilmington, Delaware, United States
Cardiology Associates of South Florida
🇺🇸Boynton Beach, Florida, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Empire Clinical Research, LLC
🇺🇸Miami Lakes, Florida, United States
Cardiology Partners Clinical Research Institute
🇺🇸Wellington, Florida, United States
Cardiology Consultants
🇺🇸Pensacola, Florida, United States
Florida Hospital Transplant Institute
🇺🇸Orlando, Florida, United States
Avanza Medical Research Center
🇺🇸Pensacola, Florida, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Louisiana Heart Center
🇺🇸Slidell, Louisiana, United States
Duke Cardiology of Lumberton
🇺🇸Lumberton, North Carolina, United States
Piedmont Heart Institute - Athens
🇺🇸Athens, Georgia, United States
Atlanta Vanguard Research Institute
🇺🇸Smyrna, Georgia, United States
Saint Luke's Boise Medical Center
🇺🇸Boise, Idaho, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
South Florida Research Solutions, LLC
🇺🇸Pembroke Pines, Florida, United States
Mount Sinai Hospital Medical Center - Department of Cardiology
🇺🇸Chicago, Illinois, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Anne Arundel Health System Research Institute
🇺🇸Annapolis, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, United States
New York Presbyterian Brooklyn Methodist Hospital
🇺🇸Brooklyn, New York, United States
Indiana University Health Ball Memorial Hospital, Inc.
🇺🇸Muncie, Indiana, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Indian River Medical Center
🇺🇸Vero Beach, Florida, United States
Trinity Medical WNY, PC
🇺🇸Cheektowaga, New York, United States
Professional Health Care of Pinellas
🇺🇸Saint Petersburg, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Northtowns Cardiology, PLLC
🇺🇸Williamsville, New York, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
St. Vincent Medical Group
🇺🇸Indianapolis, Indiana, United States
Saint Peter's University Hospital
🇺🇸New Brunswick, New Jersey, United States
Medicoricium, LLC
🇺🇸Fairview Heights, Illinois, United States
University Cardiology Associates, LLC
🇺🇸Augusta, Georgia, United States
Heart Clinic of Hammond
🇺🇸Hammond, Louisiana, United States
Aultman Cardiology Clinical Trials
🇺🇸Canton, Ohio, United States
Tulane Heart & Vascular Institute
🇺🇸New Orleans, Louisiana, United States
Wake Forest University Health Sciences
🇺🇸High Point, North Carolina, United States
Pinehurst Medical Clinic, Inc.
🇺🇸Pinehurst, North Carolina, United States
North Ohio Heart Center
🇺🇸Sandusky, Ohio, United States
Heart House Research Foundation
🇺🇸Springfield, Ohio, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Penn State Health Holy Spirit Medical Center Geisinger - Cardiology
🇺🇸Camp Hill, Pennsylvania, United States
AtlantiCare Regional Medical Center
🇺🇸Pomona, New Jersey, United States
St. Louis Heart & Vascular, PC
🇺🇸Saint Louis, Missouri, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Prisma Health
🇺🇸Columbia, South Carolina, United States
Self Regional Hospital Research Center
🇺🇸Greenwood, South Carolina, United States
Parkway Cardiology Associates, PC
🇺🇸Oak Ridge, Tennessee, United States
Dallas VA Medical Center
🇺🇸Dallas, Texas, United States
Southwest Family Medicine Associates
🇺🇸Dallas, Texas, United States
Carilion Medical Center
🇺🇸Roanoke, Virginia, United States
The University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Riverside Cardiology Specialists
🇺🇸Newport News, Virginia, United States
Ltd Israel-Georgian Medical Research Clinic "Helsicore"
🇬🇪Tbilisi, Georgia
Bokhua Memorial Cardiovascular Center
🇬🇪Tbilisi, Georgia
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Daugavpils Regional Hospital
🇱🇻Daugavpils, Latvia
Andrea Hornyik, MD
🇭🇺Miskolc, Hungary
MHAT Haskovo AD
🇧🇬Haskovo, Bulgaria
Diagnostic - Consultative Center 1 - Lom - EOOD Office of Cardiology
🇧🇬Lom, Bulgaria
Semmelweis Egyetem Városmajori Szív és- Érgyógyászati Klinika Szent Rókus Klinikai Tömb, Kardiológiai
🇭🇺Budapest, Hungary
Acad. G. Chapidze Emergency Cardiology Center
🇬🇪Tbilisi, Georgia
Second Medical Center-Sofia, EEOD - Department of Cardiology
🇧🇬Sofia, Bulgaria
ProHealth Care Inc / Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Ltd Pineo Medical Ecosistem
🇬🇪Tbilisi, Georgia
Fraser Clinical Trials
🇨🇦New Westminster, British Columbia, Canada
SMH Cardiology Clinical Trials
🇨🇦Surrey, British Columbia, Canada
МC Hipokrena
🇧🇬Sevlievo, Bulgaria
Sunshine Coast University Hospital
🇦🇺Birtinya, Queensland, Australia
MHAT Puls
🇧🇬Blagoevgrad, Bulgaria
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Clinic-LJ
🇬🇪Kutaisi, Georgia
Aleksandre Aladashvili Clinic LLC
🇬🇪Tbilisi, Georgia
Interni kardiologicka klinika FN Brno
🇨🇿Brno, Czechia
Centrum preventivní kardiologie, Karlovo nám. 32,
🇨🇿Prague, Czechia
Belvárosi Egészségház Kft
🇭🇺Zalaegerszeg, Hungary
5th City Hospital
🇧🇬Sofia, Bulgaria
Medical Center Hera EOOD - Office of Cardiology
🇧🇬Sofia, Bulgaria
Victoria Heart Institute Foundation
🇨🇦Victoria, British Columbia, Canada
Core Research Group
🇦🇺Milton, Queensland, Australia
JSC Evex Hospitals,Georgia
🇬🇪Batumi, Georgia
General University Hospital
🇨🇿Prague, Czechia
IKEM-Klinika kardiologie
🇨🇿Prague, Czechia
Gold Coast University Hospital
🇦🇺Southport, Queensland, Australia
The Queen Elizabeth Hospital
🇦🇺Adelaide, South Australia, Australia
Kardiologicka ambulance
🇨🇿Chlumec Nad Cidlinou, Czechia
Clinexpert Gyöngyös Kft
🇭🇺Gyöngyös, Hungary
Medical Center Velingrad 2017" EOOD, Office of Cardiology
🇧🇬Velingrad, Bulgaria
Lyell McEwin Hospital
🇦🇺Elizabeth Vale, South Australia, Australia
Zsigmondy Vilmos Harkányi Gyógyfürdȍ Kórház
🇭🇺Harkány, Hungary
Bács-Kiskun Megyei Kórház Kardiológiai Osztály
🇭🇺Kecskemet, Hungary
Manna Research Inc., Burlington South
🇨🇦Burlington, Ontario, Canada
General University Hospital in Prague
🇨🇿Prague, Czechia
Totara Clinical Research, Health New Lynn
🇳🇿Auckland, New Zealand
Middlemore Hospital
🇳🇿Auckland, New Zealand
Oddział Kardiologii WSzS nr 4
🇵🇱Bytom, Poland
Hawke's Bay Hospital
🇳🇿Hastings, New Zealand
Hutt Hospital
🇳🇿Lower Hutt, New Zealand
1 Wojskowy Szpital Klininiczny w Lublinie
🇵🇱Lublin, Poland
Nelson Hospital
🇳🇿Nelson, New Zealand
Wojewódzki Szpital Zespolony im. L. Rydygiera,Oddzialu Kardiologii i lntensywnej Terapii Kardiologicznej
🇵🇱Toruń, Poland
4th Military Hospital
🇵🇱Wrocław, Poland
Nowodworskie Centrum Medyczne. Ambulatoryjna Opieka Specjalistyczna
🇵🇱Nowy Dwór Mazowiecki, Poland
Proximum Centrum Usług Medycznych NZOZ
🇵🇱Wrocław, Poland
Uniwersyteckie Centrum Kliniczne
🇵🇱Warszawa, Poland
Municipal Autonomous Healthcare Institution
🇷🇺Chelyabinsk, Russian Federation
Federal State Budgetary Scientific Institution Research Institute for Complex Issues of Cardiovascular Diseases
🇷🇺Kemerovo, Russian Federation
MNCE "City Hospital № 8" of Kharkiv City Council, Cardiology Department №2
🇺🇦Kharkiv, Ukraine
Kyiv Clinic Railway Hospital №2 of the "Health Care Center" Brach at the PJSC "Ukrainian Railway"
🇺🇦Kyiv, Ukraine
Communal non-profit enterprise Kyiv City Clinical Hospital №1
🇺🇦Kyiv, Ukraine
Kyiv City Clinical Hospital of Emergency Aid,
🇺🇦Kyiv, Ukraine
"Vinnytsia Regional Clinical Treatment Diagnostic Center of Cardiovascular Pathology"
🇺🇦Vinnytsia, Ukraine
CHI Health Research Center
🇺🇸Omaha, Nebraska, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
State Budgetary Institution of Ryazan Region
🇷🇺Ryazan, Russian Federation
Saint Petersburg Research Institute of Emergency Medicine n.a. I.I. Dzhanelidze
🇷🇺St. Petersburg, Russian Federation
Saint Petersburg Research Institute of Emergency Medicine
🇷🇺St. Petersburg, Russian Federation
Federal State Budget Educational Institution of Higher Education Saratov State Medical University of the Ministry of Health of Russia
🇷🇺Saratov, Russian Federation
LLC X7 Clinical Research
🇷🇺St. Petersburg, Russian Federation
Diagnostic - Consultative Center XXII - Sofia EOOD, Office of Cardiology
🇧🇬Sofia, Bulgaria
National Multiprofile Transport Hospital Cardiology Clinic
🇧🇬Sofia, Bulgaria
Jász-Nagykun-Szolnok Megyei Hetény i Géza Kórház Kardiológiai Osztály
🇭🇺Szolnok, Hungary
Pécsi Tudomány Egyetem Klinikai Központ, I. sz. Belgyógyászati Klinika,
🇭🇺Pecs, Hungary
Trinity Health Center - Medical Arts
🇺🇸Minot, North Dakota, United States
Centrum preventivní kardiologie
🇨🇿Prague, Czechia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
SA Heart
🇦🇺Ashford, South Australia, Australia
Heart Lung Clinic
🇦🇺Darlinghurst, Sydney, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
John Hunter Hospital
🇦🇺New Lambton Heights, Australia
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Wellington Hospital
🇳🇿Newton, Wellington, New Zealand
Hauora Tairāwhiti Department of Cardiology
🇳🇿Gisborne, New Zealand
Taranaki Base Hospital
🇳🇿New Plymouth, New Zealand
Eugene Soroka, MD Inc.
🇺🇸Port Hueneme, California, United States
Monmouth Cardiology Associates, LLC
🇺🇸Eatontown, New Jersey, United States
Saint Michael's Medical Center
🇺🇸Newark, New Jersey, United States
ProLive Medical Research
🇺🇸Miami, Florida, United States
Cordova Research Institute, LLC
🇺🇸Miami, Florida, United States
Med-Care Research
🇺🇸Miami, Florida, United States
Broward Research Center
🇺🇸Pembroke Pines, Florida, United States
Springfield Medical Center
🇺🇸Panama City, Florida, United States
Hunter Holmes McGuire V.A. Medical Center - Cardiology Div. (111J)
🇺🇸Richmond, Virginia, United States
Texas Health Research & Education Institute
🇺🇸Fort Worth, Texas, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States
ITB Research
🇺🇸Miami, Florida, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Cardiology Associates Research, LLC
🇺🇸Tupelo, Mississippi, United States
Advanced Cardiovascular, LLC
🇺🇸Auburn, Alabama, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Carondelet Heart and Vascular Institute - Cardiology East
🇺🇸Tucson, Arizona, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Westside Medical Associates of Los Angeles
🇺🇸Beverly Hills, California, United States
California Heart Specialists
🇺🇸Huntington Beach, California, United States
Harbor-UCLA Medical Center
🇺🇸Carson, California, United States
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
Healthcare Partners Affiliation Medical Group
🇺🇸Long Beach, California, United States
South Denver Cardiology Associates, PC
🇺🇸Littleton, Colorado, United States
Interventional Cardiology Medical Group
🇺🇸West Hills, California, United States
Stamford Hospital
🇺🇸Stamford, Connecticut, United States
Cardiovascular & Vein Center of Florida
🇺🇸Bradenton, Florida, United States
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
UF Health Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Vincent's Healthcare - Southside Recruiting
🇺🇸Jacksonville, Florida, United States
Piedmont Heart Institute Fayetteville
🇺🇸Fayetteville, Georgia, United States
Georgia Arrhythmia Consultants and Research Institute
🇺🇸Macon, Georgia, United States
Mercer University
🇺🇸Macon, Georgia, United States
Franciscan Physician Network - Indiana Heart Physicians
🇺🇸Indianapolis, Indiana, United States
Alexandria Cardiology Clinic
🇺🇸Alexandria, Louisiana, United States
Reid Physician Associates / Reid Health
🇺🇸Richmond, Indiana, United States
Ochsner Health System
🇺🇸New Orleans, Louisiana, United States
Beacon Medical Group Advanced Cardiovascular Specialists
🇺🇸South Bend, Indiana, United States
Maine Medical Partners Maine Health Cardiology
🇺🇸Scarborough, Maine, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
NECCR Prima Care Research, LLC
🇺🇸Fall River, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Michigan CardioVascular Institute at Covenant Medical Center
🇺🇸Saginaw, Michigan, United States
Western Michigan University Homer Stryker M.D. School of Medicine
🇺🇸Kalamazoo, Michigan, United States
Englewood Health
🇺🇸Englewood, New Jersey, United States
Advanced Heart & Vascular Institute of Hunterdon
🇺🇸Flemington, New Jersey, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Cardio Metabolic Institute
🇺🇸Somerset, New Jersey, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Circuit Clinical
🇺🇸West Seneca, New York, United States
Asheville Cardiology Associates
🇺🇸Asheville, North Carolina, United States
Medication Management, LLC
🇺🇸Greensboro, North Carolina, United States
NC Heart & Vascular Research
🇺🇸Raleigh, North Carolina, United States
WakeMed Health and Hospitals
🇺🇸Raleigh, North Carolina, United States
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Stern Cardiovascular Foundation
🇺🇸Germantown, Tennessee, United States
Carolina Heart Specialists
🇺🇸Lancaster, South Carolina, United States
Black Hills Cardiovascular Research, a department of Rapid City Regional Hospital, Inc.
🇺🇸Rapid City, South Dakota, United States
Amarillo Hearth Clinical Research Institute, Inc.
🇺🇸Amarillo, Texas, United States
PharmaTex Research
🇺🇸Tyler, Texas, United States
Tennova Healthcare-Turkey Creek Medical Center
🇺🇸Knoxville, Tennessee, United States
Houston Heart & Vascular Associates
🇺🇸Kingwood, Texas, United States
North Dallas Research Associates
🇺🇸McKinney, Texas, United States
Angelina Medical Research, LLC
🇺🇸Lufkin, Texas, United States
South Texas Cardiovascular Consultants, PLLC
🇺🇸San Antonio, Texas, United States
North Texas Research Associates
🇺🇸McKinney, Texas, United States
The University of Texas Health Center at Tyler
🇺🇸Tyler, Texas, United States
Baylor Scott & White Medical Center
🇺🇸Temple, Texas, United States
Wichita Falls Heart Clinic
🇺🇸Wichita Falls, Texas, United States
Advanced Clinical Research/Intermountain Heart Center PC
🇺🇸West Jordan, Utah, United States
Stroobants Cardiovascular Center
🇺🇸Lynchburg, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
VCU Medical Center
🇺🇸Richmond, Virginia, United States
Selma Medical Associates
🇺🇸Winchester, Virginia, United States
Providence Regional Medical Center Everett
🇺🇸Everett, Washington, United States
Providence Sacred Heart Medical Center & Children's Hospital
🇺🇸Spokane, Washington, United States
Swedish Heart & Vascular-Advanced Cardiac Support Program
🇺🇸Seattle, Washington, United States
Wenatchee Valley Hospital & Clinics
🇺🇸Wenatchee, Washington, United States
Walla Walla Clinic
🇺🇸Walla Walla, Washington, United States
CHI Franciscan Research Center
🇺🇸Tacoma, Washington, United States
Cairns Hospital
🇦🇺Cairns, Queensland, Australia
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Royal Hobart Hospital
🇦🇺Hobart, Tasmania, Australia
Multiprofile Hospital for Active Treatment: Department of cardiology
🇧🇬Gabrovo, Bulgaria
Epworth HealthCare Clinical Trials
🇦🇺Richmond, Australia
Macquarie University - Clinical Trials Unit
🇦🇺Macquarie Park, Australia
Medical Center Medconsult Pleven OOD
🇧🇬Pleven, Bulgaria
Klaipeda Seaman's Hospital
🇱🇹Klaipėda, Lithuania
Second Multiprofile Hospital for Active Treatment
🇧🇬Sofia, Bulgaria
Multiprofile Regional Hospital for Active Treatment
🇧🇬Veliko Tarnovo, Bulgaria
Vizel Cardiac Research
🇨🇦Cambridge, Ontario, Canada
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Sinai Health System - Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
🇨🇦Montréal, Quebec, Canada
CISSS de Chaudière-Appalaches (CISSS-CA), site Hôpital St-Georges
🇨🇦Saint-Georges, Quebec, Canada
Semmelweis Egyetem Városmajori Szív- és Érgyógyászati Klinika
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Központ Kardiológiai Osztály
🇭🇺Debrecen, Hungary
Pauls Stradins Clinical University Hospital
🇱🇻Riga, Latvia
North Shore Hospital
🇳🇿Auckland, New Zealand
Auckland City Hospital
🇳🇿Auckland, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Christchurch Heart Institute
🇳🇿Christchurch, New Zealand
Rotorua Hospital
🇳🇿Rotorua, New Zealand
Clinical Horizons NEW ZEALAND LTD
🇳🇿Tauranga, New Zealand
Centrum Medyczne Linden
🇵🇱Kraków, Poland
Ko-Med Centra Kliniczne
🇵🇱Lublin, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
🇵🇱Wrocław, Poland
JSC Polyclinic Complex
🇷🇺Saint-Petersburg, Russian Federation
Saint-Petersburg State Budgetary Institution of Healthcare "Saint Martyr Elizabeth city hospital"
🇷🇺Saint Petersburg, Russian Federation
Municipal Autonomous Healthcare Institution "City Clinical Hospital #6
🇷🇺Chelyabinsk, Russian Federation
Private Medical Institution "Euromedservice
🇷🇺Pushkin, Russian Federation
State Budgetary Healthcare Institution of Moscow city "Moscow
🇷🇺Moscow, Russian Federation
LLC "Scientific Research Center Eco-Safety"
🇷🇺Saint Petersburg, Russian Federation
State Healthcare Institution
🇷🇺Saratov, Russian Federation
Municipal non-profit enterprise "Ivano-Frankivsk Regional Clinical Cardiological Center"
🇺🇦Ivano-Frankivs'k, Ukraine
Scientific Medical Complex "University Clinic" of Kharkiv
🇺🇦Kharkiv, Ukraine
Communal nonprofit enterprise "Oleksandrivska Clinical Hospital of Kyiv
🇺🇦Kyiv, Ukraine
Medical Centre of LLC "Medical Centre "CONSILIUM MEDICAL"
🇺🇦Kyiv, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical
🇺🇦Lviv, Ukraine
Vinnytsia Regional Clinical Hospital of Veterans of War
🇺🇦Vinnytsia, Ukraine
Educational and Research Medical Center "University Clinic" at Zaporizhzhia State Medical University of the Ministry of Health of Ukraine,
🇺🇦Zaporizhzhia, Ukraine
Сommunal Institution "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia Regional Council,
🇺🇦Zaporizhzhia, Ukraine
Communal Enterprise "Hospital №1" of Zhytomyr City Council
🇺🇦Zhytomyr, Ukraine
Christiana Care
🇺🇸Newark, Delaware, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Ltd TIM- Tbilisi Institute of Medicine
🇬🇪Tbilisi, Georgia
Zespol Opieki Zdrowotnej
🇵🇱Oława, Poland
Military and Medical Clinical Center of the Northern Region (Military Unit A-3306) Cardiology Department
🇺🇦Kharkiv, Ukraine
"Oleksandrivska Clinical Hospital of Kyiv" of executive authority Kyiv City
🇺🇦Kyiv,, Ukraine
Danbury Hospital
🇺🇸Danbury, Connecticut, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Biokinetica S.A. Przychodnia Józefów
🇵🇱Józefów, Poland
Szpital Swietej Anny w Miechowie
🇵🇱Miechów, Poland
Centrum Medyczne K2J2
🇵🇱Wołomin, Poland
Municipal Non-Profit Enterprise "Consultative and Diagnostic centre" of Pechersk District of Kiyv
🇺🇦Kyiv, Ukraine
State Institution "National Scientific Center "Institute of Cardiology
🇺🇦Kyiv, Ukraine
Georgian-Dutch Hospital
🇬🇪Tbilisi, Georgia
The Hospital of Lithuanian
🇱🇹Kaunas, Lithuania
Szpital Świętej Anny w Miechowie
🇵🇱Miechów, Poland
Marcin Ogórek, MD, PhD
🇵🇱Łódź, Poland
Communal Institution "Kryvyi Rih City Hospital №9" of Kryvyi Rih City Council
🇺🇦Kryvyi Rih, Ukraine
National Scientific Center Institute of Cardiology of M.D
🇺🇦Kyiv, Ukraine
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Caprock Cardiac Center Research Institute, Inc.
🇺🇸Lubbock, Texas, United States
Health Sciences Centre
🇨🇦Saint John's, Newfoundland and Labrador, Canada
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
North Kansas City Hospital
🇺🇸North Kansas City, Missouri, United States
Crossroads Clinical Research, Inc.
🇺🇸Mooresville, North Carolina, United States
Cambridge Cardiac Care Center
🇨🇦Cambridge, Ontario, Canada