Clinical trial NCT02595814: Global Non-interventional Heart Failure Disease Registry
Official title: International Registry to Assess mEdical Practice With lOngitudinal obseRvation for Treatment of Heart Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Heart Failure
Keywords: Registry
Heart failure
Hospitalized
Global
Morbidity
Mortality
Quality of life
AHF
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 18805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Enrollment of adult patients hospitalized with a primary diagnosis of acute Heart Failure (HF), i.e. new-onset (first diagnosis) HF or decompensation of chronic HF

Brief summary: The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.


Eligibility criteria: Inclusion Criteria:

Patients at least 18 years old, or older for those countries where the adult age is above 18 years of age, hospitalized with a primary diagnosis of acute heart failure.

Exclusion Criteria:

1-Concomitant participation in any/a clinical trial with any investigational treatment (for any sponsor).

2. Use of investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.

Primary outcomes:
measure: Number of patients with different characteristics of heart faliure (HF) at hospitalization
timeFrame: From admission to discharge of the patient's index hospitalization (minimum 24 hours)
measure: Percentage of patients who die during the index hospitalization
timeFrame: From admission to discharge of the patient's index hospitalization (minimum 24 hours)
measure: Percentage of patients who die during the follow-up period post-discharge
timeFrame: up to 3 years
measure: Percentage of patients who are re-hospitalized by primary re-hospitalization reason (Cardiovascular and non-Cardiovascular)
timeFrame: up to 3 years
measure: Number of patients with different characteristics of post-discharge patient management
timeFrame: up to 3 years
measure: Healthcare Resource Utilization assessed by number of patients with re-hospitalizations
timeFrame: up to 3 years
Secondary outcomes:
measure: Health-related Quality of life (HRQoL) based on patient reported data as measured by EQ-5D and the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires
timeFrame: up to 3 years
measure: Caregiver burden based on Caregiver Burden Questionnaire -Heart Failure (CBQ-HF) and Work Productivity and Activity Impairment (WPAI) questionnaires
timeFrame: up to 3 years
measure: Correlation ratio between practice patterns and outcomes
timeFrame: up to 3 years
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Francisco
country: United States
facility: Novartis Investigative Site
state: California
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Kansas
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Stony Brook
country: United States
facility: Novartis Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Algiers
country: Algeria
facility: Novartis Investigative Site
city: Algiers
country: Algeria
facility: Novartis Investigative Site
city: Algiers
country: Algeria
facility: Novartis Investigative Site
city: Oran
country: Algeria
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city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Resistencia
country: Argentina
facility: Novartis Investigative Site
state: Chaco
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
state: Ciudad De Buenos Aires
city: Coronel Suarez
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facility: Novartis Investigative Site
state: Ciudad De Buenos Aires
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Rosario
country: Argentina
facility: Novartis Investigative Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Buenos Aires
country: Argentina
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city: Bedford Park
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country: Austria
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city: Wien
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city: Belo Horizonte
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city: Curitiba
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city: Rio de Janeiro
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city: Campinas
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city: Tatuí
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city: Curitiba
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facility: Novartis Investigative Site
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country: Bulgaria
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country: Canada
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city: Vancouver
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city: Halifax
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city: Ottawa
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city: Sainte-Foy
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city: Concepcion
country: Chile
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city: Santiago
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city: Santiago
country: Chile
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city: Beijing
country: China
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state: Beijing
city: Beijing
country: China
facility: Novartis Investigative Site
state: Beijing
city: Fuzhou
country: China
facility: Novartis Investigative Site
state: Fujian
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Shijiazhuang
country: China
facility: Novartis Investigative Site
state: Hebei
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Changsha
country: China
facility: Novartis Investigative Site
state: Hunan
city: Baotou
country: China
facility: Novartis Investigative Site
state: Inner Mongolia
city: Changchun
country: China
facility: Novartis Investigative Site
state: Jilin
city: Dalian
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Beijing
country: China
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city: Beijing
country: China
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city: Beijing
country: China
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city: Beijing
country: China
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city: Beijing
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city: Guang Zhou
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city: Luoyang
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city: Yangzhou
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city: Zhengzhou
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city: Zhengzhou
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city: Medellin
country: Colombia
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state: Antioquia
city: Medellin
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facility: Novartis Investigative Site
state: Atlantico
city: Barranquilla
country: Colombia
facility: Novartis Investigative Site
state: Atlántico
city: Bogotá
country: Colombia
facility: Novartis Investigative Site
state: Cundinamarca
city: Bucaramanga
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state: Santander
city: Armenia
country: Colombia
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city: Bogota
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country: Colombia
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country: Colombia
facility: Novartis Investigative Site
city: Cali
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city: Guayaquil
country: Ecuador
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state: Guayas
city: Quito
country: Ecuador
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state: Pichincha
city: Guayaquil
country: Ecuador
facility: Novartis Investigative Site
city: Portoviejo
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facility: Novartis Investigative Site
city: Alexandria
country: Egypt
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city: Cairo
country: Egypt
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city: Cairo
country: Egypt
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city: El Menia, Upper Egypt
country: Egypt
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city: Suez Canal Region
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facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
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city: Essen
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facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Goettingen
country: Germany
facility: Novartis Investigative Site
city: Halle
country: Germany
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city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Homburg
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Ludwigshafen
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facility: Novartis Investigative Site
city: Nürnberg
country: Germany
facility: Novartis Investigative Site
city: Wurzburg
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
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state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
state: GR
city: Thessaloniki
country: Greece
facility: Novartis Investigative Site
state: GR
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Glyfada
country: Greece
facility: Novartis Investigative Site
city: Ioannina
country: Greece
facility: Novartis Investigative Site
city: Piraeus
country: Greece
facility: Novartis Investigative Site
city: Thessaloniki
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city: Guatemala City
country: Guatemala
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city: Guatemala
country: Guatemala
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city: Guatemala
country: Guatemala
facility: Novartis Investigative Site
city: New Delhi
country: India
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state: Delhi
city: New Delhi
country: India
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state: Delhi
city: New Delhi
country: India
facility: Novartis Investigative Site
state: Delhi
city: Panaji
country: India
facility: Novartis Investigative Site
state: Goa
city: Ahmedabad
country: India
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state: Gujarat
city: Vadodara
country: India
facility: Novartis Investigative Site
state: Gujarat
city: Gurgaon
country: India
facility: Novartis Investigative Site
state: Haryana
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Manipal
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Nagpur
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Amritsar
country: India
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state: Punjab
city: Ludhiana
country: India
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state: Punjab
city: Ludhiana
country: India
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state: Punjab
city: Chennai
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state: Tamil NADU
city: Hyderabad
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state: Telangana
city: Hyderabad
country: India
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state: Telangana
city: Kolkata
country: India
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state: West Bengal
city: Kolkata
country: India
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state: West Bengal
city: India
country: India
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city: Mumbai
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city: New Delhi
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city: New Delhi
country: India
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city: Tangerang
country: Indonesia
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state: Banten
city: East Jakarta
country: Indonesia
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state: DKI Jakarta
city: South Jakarta
country: Indonesia
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state: DKI Jakarta
city: West Jakarta
country: Indonesia
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state: DKI Jakarta
city: Surabaya
country: Indonesia
facility: Novartis Investigative Site
state: East Java
city: Medan
country: Indonesia
facility: Novartis Investigative Site
state: North Sumatera
city: Padang
country: Indonesia
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state: Sumatera Barat
city: Bandung
country: Indonesia
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state: West Java
city: Bekasi
country: Indonesia
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state: West Java
city: Jerusalem
country: Israel
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city: Kfar-Saba
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city: Nazareth
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city: Sefad
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country: Japan
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state: Fukuoka
city: Kure
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city: Sakaide-city
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state: Kagawa
city: Kita-ku
country: Japan
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state: Okayama
city: Hirakata-City
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state: Osaka
city: Chiyoda-ku
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state: Tokyo
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city: Amman
country: Jordan
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city: Amman
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city: Gyeonggi-do
country: Korea, Republic of
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state: Chungcheongbuk-do
city: Wonju
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city: Daejeon
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state: Korea
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
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city: Taegu
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city: El Chouf
country: Lebanon
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state: LBN
city: Beirut
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city: Beirut
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city: Kota Bahru
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state: Kelantan
city: Pulau Pinang
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city: Johor Bahru
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city: Mexico
country: Mexico
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city: Mexico
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state: Distrito Federal
city: Culiacán
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state: Sinaloa SN
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country: Morocco
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country: Netherlands
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country: Panama
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country: Russian Federation
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state: Kwa-Zulu Natal
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city: Cape Town
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city: Cape Town
country: South Africa
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country: South Africa
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city: Mallorca
country: Spain
facility: Novartis Investigative Site
state: Islas Baleares
city: Las Palmas de Gran Canaria
country: Spain
facility: Novartis Investigative Site
state: Las Palmas De G.C
city: Majadahonda
country: Spain
facility: Novartis Investigative Site
state: Madrid
city: Barakaldo
country: Spain
facility: Novartis Investigative Site
state: Pais Vasco
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Cordoba
country: Spain
facility: Novartis Investigative Site
city: Leon
country: Spain
facility: Novartis Investigative Site
city: Murcia
country: Spain
facility: Novartis Investigative Site
city: Göteborg
country: Sweden
facility: Novartis Investigative Site
city: Helsingborg
country: Sweden
facility: Novartis Investigative Site
city: Karlshamn
country: Sweden
facility: Novartis Investigative Site
city: Linkoping
country: Sweden
facility: Novartis Investigative Site
city: Malmö
country: Sweden
facility: Novartis Investigative Site
city: Trollhättan
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bruderholz
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Lin-Kou
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Monastir
country: Tunisia
facility: Novartis Investigative Site
city: Sousse
country: Tunisia
facility: Novartis Investigative Site
city: Tunis
country: Tunisia
facility: Novartis Investigative Site
city: Tunis
country: Tunisia
facility: Novartis Investigative Site
city: Tunis
country: Tunisia
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Bursa
country: Turkey
facility: Novartis Investigative Site
city: Bursa
country: Turkey
facility: Novartis Investigative Site
city: Diskapi / Ankara
country: Turkey
facility: Novartis Investigative Site
city: Haydarpasa/Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Meselik / Eskisehir
country: Turkey
facility: Novartis Investigative Site
city: Pendik / Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Sivas
country: Turkey
facility: Novartis Investigative Site
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Al Ain
country: United Arab Emirates
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: Edgbaston
country: United Kingdom
facility: Novartis Investigative Site
state: Birmingham
city: Stockton on Tees
country: United Kingdom
facility: Novartis Investigative Site
state: Cleveland
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Chesterfield
country: United Kingdom
facility: Novartis Investigative Site
state: Yorkshire
city: Herts
country: United Kingdom
facility: Novartis Investigative Site
state: Yorkshire
city: Chesterfield
country: United Kingdom
facility: Novartis Investigative Site
city: Telford
country: United Kingdom
facility: Novartis Investigative Site
city: Uxbridge
country: United Kingdom
facility: Novartis Investigative Site
city: Wakefield
country: United Kingdom
facility: Novartis Investigative Site
city: York
country: United Kingdom
facility: Novartis Investigative Site
city: Ho Chi Minh City
country: Vietnam
facility: Novartis Investigative Site
city: Ho Chi Minh City
country: Vietnam
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
Study officials:
References:
citation: Filippatos G, Khan SS, Ambrosy AP, Cleland JG, Collins SP, Lam CS, Angermann CE, Ertl G, Dahlstrom U, Hu D, Dickstein K, Perrone SV, Ghadanfar M, Bermann G, Noe A, Schweizer A, Maier T, Gheorghiade M. International REgistry to assess medical Practice with lOngitudinal obseRvation for Treatment of Heart Failure (REPORT-HF): rationale for and design of a global registry. Eur J Heart Fail. 2015 May;17(5):527-33. doi: 10.1002/ejhf.262. Epub 2015 Mar 10.