Clinical trial NCT03549754: iCaReMe Global Registry
Official title: Real-world Multinational Registry to Determine Management and Quality of Care of Patients With Type 2 Diabetes, Hypertension, Heart Failure and/or Chronic Kidney Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes
Hypertension
Chronic Kidney Disease
Heart Failure
Keywords: Registry
Type 2 Diabetes
T2DM
Chronic Kidney Disease
CKD
Hypertension
HTN
Adult population
Heart Failure
HF
Early cardiorenal complications
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 35000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease

Brief summary: To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

Detailed description: The registry intends to provide real world data on patient management and quality of care for patients with T2DM, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart Failure and Chronic Kidney Disease. Multinational, observational registry utilizing a cloud-based eCRF, for prospective and retrospective data collection, accessible to investigators and Scientific Committee. This registry will be open to all physicians managing T2DM, HTN, HF or CKD across the world.

Eligibility criteria: Inclusion Criteria:

1. Being 18 years or older
2. Having type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease
3. Providing written informed consent to participate in the registry

Exclusion Criteria:

1. Having a life-threatening co-morbidity with life expectancy below 1 year
2. Participating in an interventional trial requiring informed consent

Primary outcomes:
measure: 1. Provide real world data on patient characteristics
timeFrame: Average of 3 years through study completion
measure: 2. Provide real world data on disease management
timeFrame: Average of 3 years through study completion
measure: 3. Provide real world data on healthcare utilization
timeFrame: Average of 3 years through study completion
measure: 4. Provide real world data on quality of care indicators
timeFrame: Average of 3 years through study completion
measure: Provide real world data on cardiovascular outcomes in patients with type 2 diabetes; Chronic Kidney Disease and Heart Failure
timeFrame: Average of 3 years through study completion
measure: 6. Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes and Heart Failure
timeFrame: Average of 3 years through study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Research Site
state: Bahia
city: Fortaleza
country: Brazil
facility: Research Site
state: Ceará
city: Brasília
country: Brazil
facility: Research Site
state: Distrito Federal
city: Colatina
country: Brazil
facility: Research Site
state: Espírito Santo (ES)
city: Poços de Caldas
country: Brazil
facility: Research Site
state: Minas Gerais
city: Campina Grande do Sul
country: Brazil
facility: Research Site
state: Paraná
city: Teresina
country: Brazil
facility: Research Site
state: Piauí (PI)
city: Santa Cruz do Sul
country: Brazil
facility: Research Site
state: Rio Grande Do Sul (RS)
city: Goiânia
country: Brazil
facility: Research Site
state: State Of Goiás
city: Joinville
country: Brazil
facility: Research Site
state: State Of Santa Catarina
city: Bragança Paulist
country: Brazil
facility: Research Site
state: São Paulo
city: São Caetano do Sul
country: Brazil
facility: Research Site
state: São Paulo
city: São Paulo
country: Brazil
facility: Research Site
city: São Paulo
country: Brazil
facility: Research Site
city: Providencia
country: Chile
facility: Research Site
state: Santiago Metropolitan Region
city: Abidjan
country: Côte D'Ivoire
facility: Research Site
city: Wan Chai District
country: Hong Kong
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
city: Sulaimani
country: Iraq
facility: Research Site
city: Almaty
country: Kazakhstan
facility: Research Site
city: Almaty
country: Kazakhstan
facility: Research Site
city: Almaty
country: Kazakhstan
facility: Research Site
city: Almaty
country: Kazakhstan
facility: Research Site
city: Nairobi
country: Kenya
facility: Research Site
city: Kuala Lumpur, Selangor
country: Malaysia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: León
country: Mexico
facility: Research Site
state: Guanajuato
city: Ciudad de México
country: Mexico
facility: Research Site
city: Colonia Doctores Neighborhood
country: Mexico
facility: Research Site
city: Iztapalapa
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Gwagwalada
country: Nigeria
facility: Research Site
city: Kano
country: Nigeria
facility: Research Site
city: Florida
country: South Africa
facility: Research Site
city: Parow
country: South Africa
facility: Research Site
city: Umhlanga
country: South Africa
facility: Research Site
city: Niaosong Dist
country: Taiwan
facility: Research Site
state: Kaohsiung
city: Changhua City
country: Taiwan
facility: Research Site
city: Kaohsiung City
country: Taiwan
facility: Research Site
city: Taichung City
country: Taiwan
facility: Research Site
city: Taichung City
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan City
country: Taiwan
facility: Research Site
city: Dnipro
country: Ukraine
facility: Research Site
state: Dnipropetrovsk Oblast
city: Kharkiv
country: Ukraine
facility: Research Site
state: Kharkiv Oblast
city: Kharkiv
country: Ukraine
facility: Research Site
state: Kharkiv Oblast
city: Kyiv
country: Ukraine
facility: Research Site
state: Kyiv Oblast
city: Kyiv
country: Ukraine
facility: Research Site
state: Kyiv Oblast
city: Vinnytsia
country: Ukraine
facility: Research Site
state: Vinnytsia Oblast
city: Lutsk
country: Ukraine
facility: Research Site
state: Volyn Oblast
city: Uzhhorod
country: Ukraine
facility: Research Site
state: Zakarpattia Oblast
city: Zaporizhzhia
country: Ukraine
facility: Research Site
state: Zaporizhzhia Oblast
city: Sharjah
country: United Arab Emirates
facility: Research Site
Study officials:
References: