Clinical trial NCT06200207: A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation
Official title: Effects of Ziltivekimab Versus Placebo on Heart Failure Symptoms and Physical Function in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Heart Failure
Systemic Inflammation
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-01-10
Enrollment: 680
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 study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.


Eligibility criteria: Inclusion Criteria:

* Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
* Disease specific - cardiovascular:
* N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening
* Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
* Left ventricular ejection fraction (LVEF) greater than 40 percent documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (example myocardial infarction (MI) or heart failure (HF) hospitalisation)
* Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:

  1. Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2)
  2. LA diameter greater than or equal to 3.8 centimeter (cm)
  3. LA length greater than or equal to 5.0 cm
  4. LA area greater than or equal to 20 square centimeter (cm\^2)
  5. LA volume greater than or equal to 55 milliliter (mL)
  6. Intraventricular septal thickness greater than or equal to 1.1 cm
  7. Posterior wall thickness greater than or equal to 1.1 cm
  8. LV mass index greater than or equal to 115 gram per square meter (g/m\^2) in men or greater than or equal to 95 g/m\^2 in women

  h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeter per second (cm/s)
* No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
* Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres
* Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening

Exclusion Criteria:

* Medical conditions - cardiovascular:
* Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
* Systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than or equal to 3 antihypertensive drugs
* Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1)
* Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
* Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
* Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2)
* Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease
* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
* Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)
* Medical conditions - infections/immunosuppression:
* Clinical evidence of, or suspicion of, active infection at the discretion of the investigator

Primary outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
Secondary outcomes:
measure: Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Participants improving 5 points or more in KCCQ-CSS (yes/no)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Participants improving 10 points or more in KCCQ-CSS (yes/no)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Change in six-minute walk distance (6MWD)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Change in high-sensitivity C-reactive protein (hs-CRP)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Participants experiencing improvement in New York heart association (NYHA) Class (yes/no)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
measure: Change in eGFR (CKD-EPI)
timeFrame: From randomisation (month 0) to end-of-treatment (month 12)
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Advanced Cardiovascular, LLC
state: Alabama
city: Fairhope
country: United States
facility: Eastern Shore Rsrch Inst, LLC
state: Alabama
city: Little Rock
country: United States
facility: Cardiology & Medicine Clinic
state: Arkansas
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Orange
country: United States
facility: UCI Health
state: California
city: Pasadena
country: United States
facility: South California Heart Spc
state: California
city: Largo
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Ocala
country: United States
facility: Ocala Cardiovascular Research
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Research
state: Florida
city: Saint Augustine
country: United States
facility: St Johns Ctr Clin Rsch-St. Aug
state: Florida
city: Macon
country: United States
facility: GA Arrhythmia Cons & Rsch Inst
state: Georgia
city: Savannah
country: United States
facility: Velocity Clin Rsrch - Savannah
state: Georgia
city: Hazel Crest
country: United States
facility: Chicago Medical Research LLC
state: Illinois
city: Louisville
country: United States
facility: UofL Health Care Outpatient
state: Kentucky
city: Baltimore
country: United States
facility: Maryland Cardiovascular Specialists - Baltimore
state: Maryland
city: Oxon Hill
country: United States
facility: MD Medical Research
state: Maryland
city: Bloomfield Hills
country: United States
facility: Cardio and Vascular Assoc-CAVA
state: Michigan
city: Farmington Hills
country: United States
facility: Millennium Cardiology
state: Michigan
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Lake Success
country: United States
facility: Long Island Cardiovascular Consultants PC
state: New York
city: New York
country: United States
facility: Mount Sinai Hosp at NYC
state: New York
city: Riverhead
country: United States
facility: Northwell Health Phys Cardio
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill
state: North Carolina
city: Horsham
country: United States
facility: AMS Cardiology
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Amarillo
country: United States
facility: PharmaTex Research
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: El Paso
country: United States
facility: David Turbay, MD, PLLC
state: Texas
city: Katy
country: United States
facility: Private Practice Leadership LLC.
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Ctr, PLLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Ctr, PLLC
state: Texas
city: Sherman
country: United States
facility: Sherman Clinical Research
state: Texas
city: Tomball
country: United States
facility: Northwest Heart Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Clinical Research
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Lanus Este
country: Argentina
facility: Centro Médico CIMEL
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes SRL
city: Buenos Aires
country: Argentina
facility: CIPREC Pueyrredon
city: Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
city: Caba
country: Argentina
facility: Centro de Investigación y Prevención Cardiovascular
city: City of Buenos Aires
country: Argentina
facility: Cardiologia Palermo_LOC#1
city: Esperanza, Santa Fe
country: Argentina
facility: Sanatorio Esperanza
city: Morón
country: Argentina
facility: Consultorio Integral de Atención al Diabético
city: Salta
country: Argentina
facility: Centro Cardiovascular Salta
city: San Miguel De Tucumán, Tucumán.
country: Argentina
facility: Investigaciones Clinicas Tucuman
city: Garran
country: Australia
facility: The Canberra Hospital_Garran
state: Australian Capital Territory
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Illawarra Heart Health Centre
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Ballarat
country: Australia
facility: Ballarat Base Hospital
state: Victoria
city: Epping
country: Australia
facility: The Cardiologists Pty Ltd
state: Victoria
city: Epping
country: Australia
facility: The Cardiologists Pty Ltd
state: Victoria
city: Mulgrave
country: Australia
facility: Advara HeartCare
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital Cardiology
state: Western Australia
city: Blagoevgrad
country: Bulgaria
facility: MHAT "Puls" AD Cardiology Department
city: Haskovo
country: Bulgaria
facility: MHAT Haskovo AD
city: Pleven
country: Bulgaria
facility: MHAT Heart and Brain
city: Plovdiv
country: Bulgaria
facility: "UMHAT "Sveti Georgi" EAD
city: Sofia
country: Bulgaria
facility: "Medical Center Hera" EOOD - Sofia
city: Sofia
country: Bulgaria
facility: Medical center ISUL - Tsaritsa Yoanna EOOD
city: Sofia
country: Bulgaria
facility: "UMHATEM N.I. Pirogov" EAD
city: Sofia
country: Bulgaria
facility: "UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology
city: Sofia
country: Bulgaria
facility: Medical Center Synexus Sofia
city: Calgary
country: Canada
facility: University of Calgary_Calgary
state: Alberta
city: Cambridge
country: Canada
facility: Cambridge Cardiac Care Centre
state: Ontario
city: Cambridge
country: Canada
facility: Saul Vizel Pro. Med. Corp
state: Ontario
city: Scarborough
country: Canada
facility: Corcare Cardiovascular Research
state: Ontario
city: Toronto
country: Canada
facility: Diabetes Heart Research Centre
state: Ontario
city: Waterloo
country: Canada
facility: CPS Research
state: Ontario
city: Waterloo
country: Canada
facility: Clinical Research Solutions Inc.
state: Ontario
city: Montreal
country: Canada
facility: Institut de Cardiologie de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec-Uni Laval-Hotel
city: Benešov
country: Czechia
facility: Innera s.r.o.
city: Brno
country: Czechia
facility: Kardiologicka ambulance Brno s.r.o.
city: Brno
country: Czechia
facility: Vojenská nemocnice Brno p.o.
city: Chomutov
country: Czechia
facility: Ordinace pro choroby srdce
city: Praha 7
country: Czechia
facility: MEDICON a.s.
city: Svitavy
country: Czechia
facility: Svitavska nemocnice Kardiologie
city: Trutnov
country: Czechia
facility: Kardiologie Trutnov Ferkl
city: Třinec
country: Czechia
facility: Nemocnice AGEL Třinec-Podlesí a.s.
city: Chambray Les Tours
country: France
facility: Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Rouen cedex
country: France
facility: Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse
city: Valenciennes
country: France
facility: Polyclinique Vauban
city: Vandoeuvre Les Nancy
country: France
facility: Chru de Nancy - Hopital Brabois
city: Bremen
country: Germany
facility: Kardiologisch-Angiologische Praxis Herzzentrum Bremen
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH Universitätsklinik
city: Elsterwerda
country: Germany
facility: Zentrum fuer klinische Studien Suedbrandenburg GmbH
city: Erfurt
country: Germany
facility: Hospitalvereinigung TH-Kath. KH St. Johann Nepomuk-Innere Med. II
city: Frankfurt
country: Germany
facility: MVZ CCB Frankfurt Und Main-Taunus GbR
city: Freiburg
country: Germany
facility: Medical Center - University Of Freiburg
city: Fulda
country: Germany
facility: MVZ im Altstadt-Carree Fulda GmbH - Zentrum für klinische Studien
city: Homburg
country: Germany
facility: UKS - Innere Medizin III
city: Kaiserslautern
country: Germany
facility: Kardiopraxis Schirmer
city: Mainz
country: Germany
facility: Gesundheitscentrum Mainz (Regner / Schmitt)
city: Athens
country: Greece
facility: Alexandra General Hospital, Therapeutic Clinic
state: Attiki
city: Athens
country: Greece
facility: Evangelismos Hospital
city: Athens
country: Greece
facility: Naval Hospital of Athens
city: Athens
country: Greece
facility: "Laiko" General Hospital of Athens
city: Athens
country: Greece
facility: 'G. Gennimatas' General Hospital of Athens
city: Athens
country: Greece
facility: 'G. Gennimatas' General Hospital of Athens
city: Athens
country: Greece
facility: Konstantopouleio G.H. of Athens, "Agia Olga"
city: Athens
country: Greece
facility: "Hygeia" General Hospital of Athens
city: Athens
country: Greece
facility: Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
city: Athens
country: Greece
facility: Naval Hospital of Athens
city: Chaidari, Athens
country: Greece
facility: U.G.H of Athens "Attikon"
city: Chaidari, Athens
country: Greece
facility: U.G.H of Athens "Attikon"
city: Chalkida
country: Greece
facility: General Hospital of Chalkida
city: Chios
country: Greece
facility: General Hospital of Chios "Skilitsio"
city: Larissa
country: Greece
facility: Univ Gen Hospital Larisa, Cardiology Medicine Clinic
city: Marousi
country: Greece
facility: Sismanogleio General Hospital
city: Thessaloniki
country: Greece
facility: "AHEPA" University General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: 'Ippokrateio' General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt
city: Vijaywada
country: India
facility: Siddhartha Medical College & Government General Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andra Pradesh
city: New Delhi
country: India
facility: G B Pant Institute of Postgraduate Medical Education and Research
state: Delhi
city: New Delhi
country: India
facility: G B Pant Institute of Postgraduate Medical Education and Research
state: Delhi
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
state: Delhi
city: New Delhi
country: India
facility: Vardhaman Mahavir Medical College & Safdarjung Hospital
state: Delhi
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: New Delhi
country: India
facility: Rajiv Gandhi Super Speciality Hospital
state: Delhi
city: Vadodara
country: India
facility: Rhythm Heart Institute
state: Gujarat
city: Belagavi
country: India
facility: KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
state: Karnataka
city: Belagavi
country: India
facility: KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
state: Karnataka
city: Bengaluru
country: India
facility: St John's Medical College Hospital
state: Karnataka
city: Bengaluru
country: India
facility: Sri Jayadeva Institute of Cardiovascular Sciences & Research
state: Karnataka
city: Bengaluru
country: India
facility: Sri Jayadeva Institute of Cardiovascular Sciences & Research
state: Karnataka
city: Mysuru
country: India
facility: Manipal Hospital, Mysuru
state: Karnataka
city: Udupi
country: India
facility: Kasturba Medical College and Hospital, Manipal
state: Karnataka
city: Udupi
country: India
facility: Kasturba Medical College and Hospital, Manipal
state: Karnataka
city: Nagpur
country: India
facility: Sengupta Hospital and Research Institute
state: Maharashtra
city: Nagpur
country: India
facility: All India Institute of Medical Sciences (AIIMS), Nagpur
state: Maharashtra
city: Nashik
country: India
facility: Chopda Medicare and Research Centre Pvt. Ltd.
state: Maharashtra
city: Nashik
country: India
facility: Chopda Medicare and Research Centre Pvt. Ltd.
state: Maharashtra
city: Nashik
country: India
facility: Vijan Hospital & Research Centre
state: Maharashtra
city: Nashik
country: India
facility: Vijan Hospital & Research Centre
state: Maharashtra
city: Pune
country: India
facility: Villoo Poonawalla Memorial Hospital
state: Maharashtra
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences (AIIMS), Bhubaneswar
state: Odisha
city: Bikaner
country: India
facility: S.P. Medical College & Associated Group of Hospitals
state: Rajasthan
city: Hyderabad
country: India
facility: Guru Nanak CARE Hospitals
state: Telangana
city: Hyderabad
country: India
facility: Malla Reddy Narayana Multispeciality Hospital
state: Telangana
city: Kanpur
country: India
facility: Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
state: Uttar Pradesh
city: Kanpur
country: India
facility: Ganesh Shankar Vidyarthe Memorial (GSVM) Medical College
state: Uttar Pradesh
city: Lucknow
country: India
facility: Dr. Ram Manohar Lohia Institute of Medical Sciences
state: Uttar Pradesh
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
state: Uttar Pradesh
city: Aligarh
country: India
facility: Jawaharlal Nehru Medical College and Hospital
state: Utter Pradesh
city: Aligarh
country: India
facility: Jawaharlal Nehru Medical College and Hospital
state: Utter Pradesh
city: Kolkata
country: India
facility: B M Birla Heart Research Centre
state: West Bengal
city: Puducherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
state: Johor
city: Alor Setar
country: Malaysia
facility: Hospital Sultanah Bahiyah
state: Kedah
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
state: Pahang
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun Ipoh
state: Perak
city: Kajang
country: Malaysia
facility: Hospital Serdang
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan Kuala Lumpur
city: Kota Bharu, Kelantan
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
city: Jelenia Góra
country: Poland
facility: Pratia S.A.
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Intercor Sp. z o.o.
state: Kujawsko-Pomorskie
city: Włocławek
country: Poland
facility: Kardio Life
state: Kujawsko-pomorskie
city: Włocławek
country: Poland
facility: Kardio Life
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi
state: Lodzkie
city: Lodz
country: Poland
facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
state: Lodzkie
city: Pulawy
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
state: Lubelskie
city: Kraków
country: Poland
facility: Cardiomedicum Sp. z o.o.
state: Malopolskie
city: Kraków
country: Poland
facility: Cardiomedicum Sp. z o.o.
state: Malopolskie
city: Oswiecim
country: Poland
facility: Formed 2 Sp. z o.o.
state: Malopolskie
city: Żyrardów
country: Poland
facility: Prywatna Praktyka Lekarska Anna Chudoba
state: Masovian
city: Kraków
country: Poland
facility: Linden sp. z o.o. sp. k.
state: Małopolskie
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie
city: Gdynia
country: Poland
facility: Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman
state: Pomorskie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
state: Pomorskie
city: Bielsko-Biała
country: Poland
facility: American Heart of Poland S.A.
city: Bydgoszcz
country: Poland
facility: 10 Wojskowy Szpital Kliniczny z Polikliniką - Samodzielny Publiczny Zakład Opieki Zdrowotnej w Bydgoszczy
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
city: Lublin
country: Poland
facility: Zanamed Medical Clinic Sp. z o.o.
city: Piotrków Trybunalski
country: Poland
facility: Trialmed Sp. z o. o.
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny W Poznaniu
city: Poznan
country: Poland
facility: Uniwersytecki Szpital Kliniczny W Poznaniu
city: Tychy
country: Poland
facility: American Heart of Poland S.A.
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
city: Guilhufe - Penafiel
country: Portugal
facility: CHTâmega e Sousa - Hospital Padre Américo
city: Lisboa
country: Portugal
facility: Hospital da Luz
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte
city: Lisbon
country: Portugal
facility: CHLO, EPE - Hospital São Francisco Xavier
city: Setubal
country: Portugal
facility: Centro Hospitalar de Setubal
city: Castilleja De La Cuesta. Sevilla
country: Spain
facility: Hospital Vithas Sevilla
state: Andalucia
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castilla Y León
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castilla Y León
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Sanlúcar de Barrameda
country: Spain
facility: Hospital Virgen del Camino - Sanlúcar de Barrameda
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Sevilla
country: Spain
facility: Clínica Nuevas Tecnologías en Diabetes y Endocrinología
city: Valencia
country: Spain
facility: Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA)
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University Sağlık Uygulama ve Arastirma
state: Odunpazari
city: Adana
country: Turkey
facility: T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
city: Adana
country: Turkey
facility: T.C. Saglık Bakanlıgı Adana Sehir Egitim ve Arastirma Hastan
city: Afyon
country: Turkey
facility: Afyonkarahisar Health Sciences University
city: Afyon
country: Turkey
facility: Afyonkarahisar Health Sciences University
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi Cardiology
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi Cardiology
city: Bursa
country: Turkey
facility: Bursa Sehir Hastanesi Cardiology
city: Edirne
country: Turkey
facility: Trakya University
city: Edirne
country: Turkey
facility: Trakya University
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura Sehir Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes University Cardiology
city: Kayseri
country: Turkey
facility: Erciyes University Cardiology
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi Hastanesi
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
state: Highland
city: Chichester
country: United Kingdom
facility: St. Richards Hospital
state: West Sussex
city: Birmingham
country: United Kingdom
facility: FutureMeds
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency dept. 2834
role: STUDY_DIRECTOR
References: