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NCT03549754 Clinical Trial

iCaReMe Global Registry

Hypertension Clinical Trial

— iCaReMe  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03549754
Other study ID # D1690R00044
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 17, 2018
Est. completion date December 31, 2025

Study information
Verified date June 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 35000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Costa Rica Research Site Los Yoses San José
Ecuador Research Site Guayaquil Guayas
Ecuador Research Site Manta Manabi
Ecuador Research Site Quito Pichincha
Ecuador Research Site Quito Pichincha
Ecuador Research Site Quito Pichincha
Egypt Research Site Agouza Giza
Egypt Research Site Al Kasr Al Eini Cairo
Egypt Research Site El Matareya Cairo
Egypt Research Site El Nozha Cairo
Egypt Research Site Faisal Giza
Egypt Research Site Maadi Cairo
Egypt Research Site Ramses Cairo
Egypt Research Site Roxy Cairo
Ghana Research Site Kumasi Ashanti Region
Greece Research Site Attica Athens
Greece Research Site Attiki Athens
Greece Research Site Attiki Athens
Greece Research Site Attiki Athens
Greece Research Site Attiki Athens
Greece Research Site Attiki Piraeus
Greece Research Site Chalkidiki Nea Moudania
Greece Research Site Lamia
Greece Research Site Larissa
Greece Research Site Thessaloniki
Greece Research Site Thessaloniki
Greece Research Site Thessaloniki
India Research Site Gujarat Ahmedabad
Indonesia Research Site Jambi Telanaipura
Kenya Research Site Eldoret
Mexico Research Site Chihuahua
Mexico Research Site Jalisco Guadalajara
Mexico Research Site Jalisco Guadalajara
Mexico Research Site Jalisco Guadalajara
Mexico Research Site Jalisco Guadalajara
Mexico Research Site Jalisco Guadalajara
Mexico Research Site Jalisco Guadalajara
Mexico Research Site Nuevo Leon Guadalupe
Mexico Research Site Nuevo Leon Monterrey
Mexico Research Site Nuevo Leon San Nicolás De Los Garza
Mexico Research Site Queretaro San Juan Del Río
Nigeria Research Site Lagos
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Peru Research Site Lima
Philippines Research Site Antipolo Rizal
Philippines Research Site Cebu
Philippines Research Site Dasmarinas Cavite
Philippines Research Site Iloilo
Philippines Research Site Marikina Metro Manila
Philippines Research Site Pasig Metro Manila
South Africa Research Site Benoni Johannesburg
South Africa Research Site Durban KwaZulu Natal

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Costa Rica,  Ecuador,  Egypt,  Ghana,  Greece,  India,  Indonesia,  Kenya,  Mexico,  Nigeria,  Peru,  Philippines,  South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1. Provide real world data on patient characteristics Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes, CKD and HF treatments Concomitant medications Average of 3 years through study completion
Primary 2. Provide real world data on disease management Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes treatments Concomitant medications Average of 3 years through study completion
Primary 3. Provide real world data on healthcare utilization Number of diabetes, Chronic Kidney Disease(CKD) and Heart Failure(HF)-related visits to a physician not at study site Number of urgent care visits for diabetes Number of diabetes, CKD and HF-related hospital emergency department visits and reason(s) for visits Number of hospitalizations, lengths of stay, and reasons for hospitalizations Average of 3 years through study completion
Primary 4. Provide real world data on quality of care indicators Smoking cessation Eye and foot examinations Dietary counselling Average of 3 years through study completion
Primary Provide real world data on cardiovascular outcomes in patients with type 2 diabetes; Chronic Kidney Disease and Heart Failure All-cause and cause-specific deaths and hospitalizations, including recurrent events Average of 3 years through study completion
Primary 6. Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes and Heart Failure All-cause and cause-specific deaths and hospitalizations, including recurrent events Average of 3 years through study completion
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