iCaReMe Global Registry

Recruiting

• Conditions: Heart Failure; Hypertension; Type 2 Diabetes; Chronic Kidney Disease

• Registration Number: NCT03549754
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study Start: 2018-02-17
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Provide real world data on patient characteristics	Average of 3 years through study completion	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
4. Provide real world data on quality of care indicators	Average of 3 years through study completion	Smoking cessation Eye and foot examinations Dietary counselling
2. Provide real world data on disease management	Average of 3 years through study completion	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
3. Provide real world data on healthcare utilization	Average of 3 years through study completion	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
Provide real world data on cardiovascular outcomes in patients with type 2 diabetes; Chronic Kidney Disease and Heart Failure	Average of 3 years through study completion	All-cause and cause-specific deaths and hospitalizations, including recurrent events
6. Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes and Heart Failure	Average of 3 years through study completion	All-cause and cause-specific deaths and hospitalizations, including recurrent events

Trial Locations

Locations (1)

Research Site; 🇦🇪 Sharjah, United Arab Emirates