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NCT06128629RecruitingPhase 3

MAGNITUDE: A Phase 3 Study of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)

MAGNITUDE: A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of NTLA-2001 in Participants With Transthyretin Amyloidosis With Cardiomyopathy (ATTR-CM)

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

To evaluate the efficacy and safety of a single dose of NTLA-2001 compared to placebo in participants with ATTR-CM.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1200 (estimated)
First submitted
8 Nov 2023
Start date
13 Dec 2023
Primary completion date
Dec 2027
Lead sponsor
Intellia Therapeutics
Diseases
Amyloidosis
NCT number
NCT06128629
EU CT number
2023-507220-23-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1200
  • From 13 Dec 2023 to the primary completion date, Dec 2027
  • 143 sites in 27 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of active malignancy within 3 years prior to screening
  • RNA silencer therapy (patisiran, inotersen and/or eplontersen) within 12 months prior to dosing. Any prior vutrisiran use is not allowed
  • Initiation of tafamidis or acoramidis within 56 days prior to study dosing

Other illness

  • New York Heart Association (NYHA) Class IV HF
  • Has hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
  • History of liver disease

Lab values

  • Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2

Other

  • Polyneuropathy Disability score of IV (confined to wheelchair or bed)
  • Uncontrolled blood pressure
  • Unable or unwilling to take vitamin A supplementation for the duration of the study

Who the study is looking for

  • Documented diagnosis of ATTR amyloidosis with cardiomyopathy
  • Medical history of heart failure (HF)
  • Symptoms of HF are optimally managed and clinically stable within 28 days prior to administration of study intervention
  • Screening NT-proBNP, a blood marker of HF severity, greater than or equal to 600 pg/mL and less than 10,000 pg/mL

Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (143)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Italiano de Buenos Aires
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Buenos AiresArgentinaRecruiting
ICBA
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Buenos AiresArgentinaRecruiting
Fundacion Favalro
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Buenos AiresArgentinaRecruiting
Hospital Italiano de Buenos Aires
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Ciudad Autonoma de Buenos AireArgentinaRecruiting
Fundacion Favaloro
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Ciudad Autonoma de Buenos AireArgentinaRecruiting
Hospital Privado de Rosario
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RosarioArgentinaRecruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaRecruiting
Noe LGA Gesundheit Region Mitte GmbH
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St. PoeltenAustriaRecruiting
Medical University of Vienna
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ViennaAustriaRecruiting
Royal Adelaide Hospital
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AdelaideAustraliaRecruiting
Eastern Health - Box Hill Hospital
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Box HillAustraliaRecruiting
Cairns Hospital
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CairnsAustraliaWithdrawn
The Canberra Hospital
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GarranAustraliaRecruiting
The Alfred Hospital
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MelbourneAustraliaRecruiting
Fiona Stanley Hospital
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PerthAustraliaRecruiting
Westmead Hospital
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WestmeadAustraliaRecruiting
Princess Alexandra Hospital
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WoolloongabbaAustraliaRecruiting
Hopital Erasme
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AnderlechtBelgiumRecruiting
Az St-Jan Brugge-Oostende A.V.
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BruggeBelgiumRecruiting
Antwerp University Hospital
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EdegemBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumRecruiting
Centro de Pesquisa NUPEC - Instituto Orizonti em Belo Horizonte
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Belo HorizonteBrazilRecruiting
UNICAMP
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CampinasBrazilRecruiting
Complexo Hospitalar de Niterói (CHN-DASA)
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NiteróiBrazilRecruiting
HCFMRP - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
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Ribeirão PretoBrazilRecruiting
CAPED - Centro Avancado de Pesquisa
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Ribeirão PretoBrazilRecruiting
Instituto de Educacao Pesquisa e Gestao em Saude
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Rio de JaneiroBrazilRecruiting
Cardiopulmonar da Bahia S.A. (Hospital Cardio Pulmonar)
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SalvadorBrazilRecruiting
Hospital Israelita Albert Einstein
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São PauloBrazilRecruiting
Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP
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São PauloBrazilRecruiting
PSEG Centro de Pesquisa Clinica S.A.
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São PauloBrazilRecruiting
Instituto Dante Pazzanese de Cardiologia
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São PauloBrazilRecruiting
Alberta Health Services - University of Calgary
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CalgaryCanadaRecruiting
Montreal Heart Institute
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MontrealCanadaRecruiting
McGill University Health Centre
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MontrealCanadaRecruiting
University Health Network, Toronto General Hospital
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TorontoCanadaRecruiting
Vancouver Coastal Health Research Institute
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VancouverCanadaRecruiting
Fakultni Nemocnice U Sv Anny V Brne
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Brno-StredCzechiaRecruiting
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyRecruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyRecruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyRecruiting
Aarhus Universitetshospital
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Aarhus NDenmarkRecruiting
Copenhagen University Hospital
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Copenhagen OeDenmarkRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MadridSpainRecruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Son Llatzer
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PalmaSpainRecruiting
Hospital Universitario de Navarra
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PamplonaSpainRecruiting
Hospital Universitario De Salamanca
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SalamancaSpainRecruiting
Assistance Publique Hopitaux De Paris
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CreteilFranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceRecruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Synexus Midlands Clinical Research Centre
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BirminghamUnited KingdomRecruiting
Synexus Wales Clinical Research Centre
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CardiffUnited KingdomRecruiting
Synexus Scotland Clinical Research Centre
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GlasgowUnited KingdomRecruiting
Synexus Hexham Clinical Research Centre
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HexhamUnited KingdomWithdrawn
Synexus Merseyside Clinical Research Centre
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LiverpoolUnited KingdomActive, not recruiting
Richmond Pharmacology
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LondonUnited KingdomRecruiting
Synexus Manchester Clinical Research Centre
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ManchesterUnited KingdomRecruiting
Semmelweis University
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Budapest VIIIHungaryRecruiting
Rambam Health Care Campus
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HaifaIsraelRecruiting
Hadassah University Hospital, Ein Karem
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JerusalemIsraelRecruiting
Sheba medical center
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Tel HaShomerIsraelRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
University Hospital Of Ferrara
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FerraraItalyRecruiting
Careggi University Hospital
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FlorenceItalyRecruiting
IRCCS Azienda Ospedaliera Metropolitana
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GenoaItalyRecruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyRecruiting
Fondazione Toscana Gabriele Monasterio
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PisaItalyRecruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyRecruiting
Cattinara Hospital
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TriesteItalyRecruiting
Kumamoto University Hospital
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KumamotoJapanRecruiting
National Cerebral and Cardiovascular Center
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OsakaJapanRecruiting
The University of Tokyo Hospital
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TokyoJapanRecruiting
Toyama University Hospital
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ToyamaJapanRecruiting
Chonnam National University Hospital
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GwangjuSouth KoreaWithdrawn
Seoul National University Hospital
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SeoulSouth KoreaWithdrawn
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaWithdrawn
Samsung Medical Center
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SeoulSouth KoreaWithdrawn
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
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Mexico CityMexicoRecruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsRecruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsRecruiting
Oslo University Hospital HF
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OsloNorwayRecruiting
New Zealand Clinical Research
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AucklandNew ZealandRecruiting
New Zealand Clinical Research
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ChristchurchNew ZealandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Unidade Local De Saude De Santa Maria E.P.E.
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LisbonPortugalRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Norrlands University Hospital
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UmeåSwedenRecruiting
National Heart Centre
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SingaporeSingaporeRecruiting
National University Hospital
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SingaporeSingaporeRecruiting
Far Eastern Memorial Hospital
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New Taipei CityTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Taipai Veterans General Hospital
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TaipeiTaiwanRecruiting
University of Michigan
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Ann ArborUnited StatesRecruiting
Emory University School of Medicine
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AtlantaUnited StatesRecruiting
Johns Hopkins University
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BaltimoreUnited StatesRecruiting
Brigham and Women's Hospital
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BostonUnited StatesRecruiting
Boston University School of Medicine
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BostonUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
Cleveland Clinic
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ClevelandUnited StatesRecruiting
Ohio Health Research Institute
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ColumbusUnited StatesRecruiting
Baylor Scott & White Research Institute
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DallasUnited StatesRecruiting
University of Texas Southwestern Medical Center
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DallasUnited StatesRecruiting
University of Colorado Denver
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DenverUnited StatesRecruiting
Barbara Ann Karmanos Cancer Institute
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DetroitUnited StatesWithdrawn
Duke University Medical Center
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DurhamUnited StatesRecruiting
Inova Fairfax Hospital
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Falls ChurchUnited StatesRecruiting
Baylor College of Medicine
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HoustonUnited StatesRecruiting
Houston Methodist Hospital
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HoustonUnited StatesRecruiting
Indiana University Health
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IndianapolisUnited StatesRecruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesRecruiting
St. Luke's Hospital
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Kansas CityUnited StatesRecruiting
University of Kentucky Gill Heart Institute
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LexingtonUnited StatesRecruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesRecruiting
Western Greater Los Angeles VA Medical Center
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Los AngelesUnited StatesRecruiting
University of Wisconsin - Madison
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MadisonUnited StatesRecruiting
Yale University School Of Medicine
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New HavenUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesRecruiting
New York University (NYU) School of Medicine - Langone Medical Center
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New YorkUnited StatesRecruiting
Stanford University
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Palo AltoUnited StatesRecruiting
Penn Presbyterian Medical Center
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PhiladelphiaUnited StatesRecruiting
University of Pittsburgh Medical Center
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PittsburghUnited StatesRecruiting
Allegheny General Hospital
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PittsburghUnited StatesRecruiting
Baylor Scott and White - The Heart Hospital Baylor Plano
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PlanoUnited StatesRecruiting
Oregon Health and Science university (OHSU)
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PortlandUnited StatesRecruiting
Virginia Commonwealth University - Department of Internal Medicine
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RichmondUnited StatesRecruiting
Mayo Clinic
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RochesterUnited StatesRecruiting
University of California, San Diego (UCSD) Medical Center
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San DiegoUnited StatesRecruiting
University of Arizona
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TucsonUnited StatesWithdrawn
MedStar Washington Hospital Center - MedStar Heart and Vascular Institute
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Washington D.C.United StatesRecruiting
Cleveland Clinic of Florida
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WestonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.