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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03037931
Other study ID # 1VIT15043
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 15, 2017
Est. completion date February 2, 2023

Study information

Verified date April 2023
Source American Regent, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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 information / eligibility

Status Completed
Enrollment 3065
Est. completion date February 2, 2023
Est. primary completion date February 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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 COVID-19 Infection into the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ferric Carboxymaltose
Intravenous Iron
Placebo
Normal Saline Solution

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
American Regent, Inc. Duke Clinical Research Institute

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  Czechia,  Georgia,  Hungary,  Latvia,  Lithuania,  New Zealand,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of death 1 year
Primary Incidence of hospitalization for heart failure 1 year
Primary Change in 6MWT distance 6 months
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