iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases (iCaReMe)

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 35000

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Brazil
  • São Paulo, Brazil, 05403-000
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 05403-900
    • Recruiting
    • Research Site
  • Ceará
    • Fortaleza, Ceará, Brazil, 60840-285
      • Recruiting
      • Research Site
  • Espírito Santo (ES)
    • Colatina, Espírito Santo (ES), Brazil, 29707-035
      • Recruiting
      • Research Site
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40730-220
      • Recruiting
      • Research Site
  • Federal District
    • Brasília, Federal District, Brazil, 70673-623
      • Recruiting
      • Research Site
  • Minas Gerais
    • Poços de Caldas, Minas Gerais, Brazil, 37706-106
      • Recruiting
      • Research Site
  • Paraná
    • Campina Grande do Sul, Paraná, Brazil, 83430-000
      • Recruiting
      • Research Site
    • Curitiba, Paraná, Brazil, 80230-020
      • Recruiting
      • Research Site
  • Piauí (PI)
    • Teresina, Piauí (PI), Brazil, 64001-450
      • Recruiting
      • Research Site
  • Rio Grande Do Sul (RS)
    • Santa Cruz do Sul, Rio Grande Do Sul (RS), Brazil, 96835-090
      • Recruiting
      • Research Site
  • State of Goias
    • Goiânia, State of Goias, Brazil, 74453-200
      • Recruiting
      • Research Site
  • State of Santa Catarina
    • Joinville, State of Santa Catarina, Brazil, 89204-248
      • Recruiting
      • Research Site
  • São Paulo
    • Bragança Paulista, São Paulo, Brazil, 12916-542
      • Recruiting
      • Research Site
    • São Caetano do Sul, São Paulo, Brazil, 09521-160
      • Recruiting
      • Research Site
• Chile
  • Santiago Metropolitan
    • Providencia, Santiago Metropolitan, Chile, 7500922
      • Recruiting
      • Research Site
• Costa Rica
  • San José, Costa Rica
    • Recruiting
    • Research Site
• Côte d’Ivoire
  • Abidjan, Côte d’Ivoire
    • Recruiting
    • Research Site
• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Research Site
  • Cairo, Egypt
    • Recruiting
    • Research Site
  • Giza, Egypt
    • Recruiting
    • Research Site
• Georgia
  • Tbilisi, Georgia
    • Recruiting
    • Research Site
• Ghana
  • Kumasi, Ghana
    • Recruiting
    • Research Site
• Hong Kong
  • Wan Chai, Hong Kong
    • Recruiting
    • Research Site
• India
  • Ahmedabad, India
    • Recruiting
    • Research Site
  • Kolkata, India, 700034
    • Recruiting
    • Research Site
  • Mumbai, India, 400006
    • Recruiting
    • Research Site
• Iraq
  • Sulaymaniyah, Iraq, 46001
    • Recruiting
    • Research Site
• Kazakhstan
  • Aktobe, Kazakhstan, 30019
    • Recruiting
    • Research Site
  • Almaty, Kazakhstan, 50000
    • Recruiting
    • Research Site
  • Almaty, Kazakhstan, 50006
    • Recruiting
    • Research Site
  • Almaty, Kazakhstan, 50012
    • Recruiting
    • Research Site
  • Almaty, Kazakhstan, 50054
    • Recruiting
    • Research Site
• Kenya
  • Nairobi, Kenya, 14497
    • Recruiting
    • Research Site
• Malaysia
  • Kuala Lumpur, Malaysia
    • Recruiting
    • Research Site
• Mexico
  • Iztapalapa, Mexico
    • Recruiting
    • Research Site
  • Mexico City, Mexico, 06720
    • Recruiting
    • Research Site
  • Mexico City, Mexico
    • Recruiting
    • Research Site
  • México, Mexico, 04530
    • Recruiting
    • Research Site
  • Guanajuato
    • León, Guanajuato, Mexico, 37549
      • Recruiting
      • Research Site
• Nigeria
  • Enugu, Nigeria, 400001
    • Recruiting
    • Research Site
  • Gwagwalada, Nigeria, 901002
    • Recruiting
    • Research Site
  • Kano, Nigeria, 700233
    • Recruiting
    • Research Site
• Philippines
  • Bulacan, Philippines
    • Not yet recruiting
    • Research Site
  • Cebu City, Philippines
    • Recruiting
    • Research Site
  • Iloilo City, Philippines
    • Not yet recruiting
    • Research Site
  • Laguna, Philippines
    • Not yet recruiting
    • Research Site
  • Mandaluyong, Philippines
    • Not yet recruiting
    • Research Site
  • Manila, Philippines
    • Not yet recruiting
    • Research Site
  • Mindoro, Philippines
    • Not yet recruiting
    • Research Site
  • Pampanga, Philippines
    • Not yet recruiting
    • Research Site
  • Quezon City, Philippines
    • Not yet recruiting
    • Research Site
  • Zamboanga City, Philippines
    • Not yet recruiting
    • Research Site
• South Africa
  • Florida, South Africa, 1794
    • Recruiting
    • Research Site
  • Parow, South Africa, 7505
    • Recruiting
    • Research Site
  • Umhlanga, South Africa, 4320
    • Recruiting
    • Research Site
  • Umhlanga, South Africa, 4319
    • Recruiting
    • Research Site
• Taiwan
  • Changhua, Taiwan, 500209
    • Recruiting
    • Research Site
  • Kaohsiung City, Taiwan, 81301
    • Recruiting
    • Research Site
  • Niaosong, Taiwan, 83301
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 40447
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 40705
    • Recruiting
    • Research Site
  • Taichung, Taiwan
    • Recruiting
    • Research Site
  • Tainan, Taiwan, 704
    • Recruiting
    • Research Site
  • Taipei, Taiwan
    • Recruiting
    • Research Site
  • Taoyuan City, Taiwan, 33305
    • Recruiting
    • Research Site
• Ukraine
  • Dnipropetrovsk Oblast
    • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49005
      • Recruiting
      • Research Site
  • Kharkiv Oblast
    • Kharkiv, Kharkiv Oblast, Ukraine, 61039
      • Recruiting
      • Research Site
    • Kharkiv, Kharkiv Oblast, Ukraine
      • Recruiting
      • Research Site
  • Kyiv Oblast
    • Kyiv, Kyiv Oblast, Ukraine, 3039
      • Recruiting
      • Research Site
    • Kyiv, Kyiv Oblast, Ukraine, 4050
      • Recruiting
      • Research Site
  • Vinnytsia Oblast
    • Vinnytsia, Vinnytsia Oblast, Ukraine, 21000
      • Recruiting
      • Research Site
  • Volyn Oblast
    • Lutsk, Volyn Oblast, Ukraine, 43024
      • Recruiting
      • Research Site
  • Zakarpattia Oblast
    • Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
      • Recruiting
      • Research Site
  • Zaporizhzhia Oblast
    • Zaporizhzhya, Zaporizhzhia Oblast, Ukraine, 69035
      • Recruiting
      • Research Site
• United Arab Emirates
  • Sharjah city, United Arab Emirates
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
T2DM Cohort; Patients with T2DM as enrollment motif or T2DM as comorbidity
HTN Cohort; Patients with HTN as enrollment motif or HTN as comorbidity
CKD Cohort; Patients with CKD as enrollment motif or CKD as comorbidity
HF Cohort; Patients with HF as enrollment motif or HF as comorbidity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Age of particpants	Age of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.	At Baseline
2. Percentage of Participants by Sex	Distribution of participants by sex (male/female) reported as counts and percentages.	At baseline
3. Percentage of Participants by Ethnicity	Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.	At Baseline
4. Percentage of Participants by Education Level	Distribution of participants by education level reported as counts and percentages for each education category.	At Baseline
5. Percentage of Participants by Marital Status	Distribution of participants by marital status reported as counts and percentages for each marital status category.	At Baseline
6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic Disease	Percentage of participants with a family history of cardiovascular, renal, or metabolic (CVRM) disease (yes/no) reported as counts and percentages.	At Baseline
7.Percentage of Participants by Physical Activity Level	Distribution of participants by physical activity level category reported as counts and percentages.	At Baseline
8. Percentage of Participants by Smoking Status	Distribution of participants by smoking status (current smoker/former smoker/never smoked) reported as counts and percentages.	At Baseline
9. Percentage of Participants by Alcohol Consumption	Distribution of participants by alcohol consumption category reported as counts and percentages.	At Baseline
10. Body Weight of Participants	Body weight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).	At Baseline
11. Height of Participants	Height of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in meters (m).	At Baseline
12. Body Mass Index (BMI) of Participants	Body mass index (BMI), calculated from weight and height, reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².	At Baseline
13. Waist Circumference of Participants	Waist circumference of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).	At Baseline
14. Waist-to-Hip Ratio of Participants	Waist-to-hip ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).	At Baseline
15. Waist-to-Height Ratio of Participants	Waist-to-height ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).	At Baseline
16. Percentage of Participants by Cardiac and Renal Functional Measurements Category	Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.	At Baseline
17. Primary Disease Duration	Duration of primary disease (T2DM, HTN, HF, or CKD) from initial diagnosis to enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.	At Baseline
18. Percentage of Participants by Number and Types of Comorbidities	Distribution of participants by number and types of comorbidities reported as counts and percentages for each comorbidity category.	At Baseline
19. Percentage of Participants by NYHA Functional Class	Distribution of heart failure participants by New York Heart Association (NYHA) functional class (I, II, III, IV) reported as counts and percentages.	At Baseline
20. Percentage of Participants by Heart Failure Phenotype	Distribution of heart failure participants by phenotype (HFrEF: ejection fraction ≤40%, HFmrEF: 41-49%, HFpEF: ≥50%) reported as counts and percentages.	At Baseline
21. Percentage of Participants by Heart Failure Etiology	Distribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.	At Baseline
22. Percentage of Participants by CKD Etiology	Distribution of chronic kidney disease participants by etiology (diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, other) reported as counts and percentages.	At Baseline
23. Percentage of Participants by Hypertension Stage	Distribution of hypertension participants by stage (Stage 1, Stage 2, Stage 3) reported as counts and percentages.	At Baseline
24. Percentage of Participants by Secondary Hypertension Etiology	Distribution of participants with secondary hypertension by etiology reported as counts and percentages for each etiology category.	At Baseline
25. Office Systolic and Diastolic Blood Pressure	Office blood pressure reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.	At Baseline
26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic Values	Home blood pressure monitoring (HBPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.	At Baseline
27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values	Ambulatory blood pressure monitoring (ABPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.	At Baseline
28. Blood HbA1c	HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %	Average of 3 years
29. Fasting Glucose	Fasting Glucose reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL	Average of 3 years
30. Lipid Profile Testing	Total cholesterol, LDL-C, HDL-C, triglycerides reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL	Average of 3 years
31. Serum Creatinine	Serum creatinine value reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.	Average of 3 years
32. Estimated Glomerular Filtration Rate (eGFR)	Estimated glomerular filtration rate (eGFR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mL/min/1.73m².	Average of 3 years
33. Urine Albumin-to-Creatinine Ratio (UACR)	Urine albumin-to-creatinine ratio (UACR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/g.	Average of 3 years
34. Serum Electrolyte Values	Serum electrolyte values (sodium, potassium, chloride, bicarbonate) reported individually as mean ± standard deviation (SD) and median with interquartile range (IQR) in mmol/L.	Avergae of 3 years
35. Frequency of HbA1c Testing	Frequency of glycated hemoglobin (HbA1c) testing reported as counts and percentages of participants tested per monitoring period.	Average of 3 years
36. Frequency of Fasting Glucose Testing	Frequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.	Average of 3 years
37. Frequency of Lipid Profile Testing	Frequency of lipid profile testing (total cholesterol, LDL-C, HDL-C, triglycerides) reported as counts and percentages of participants tested per monitoring period.	Average of 3 years
38. Frequency of Serum Creatinine Testing	Frequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.	Average of 3 years
39. Frequency of eGFR Assessment	Frequency of estimated glomerular filtration rate (eGFR) assessment reported as counts and percentages of participants assessed per monitoring period.	Average of 3 years
40. Frequency of Urine Albumin-to-Creatinine Ratio Testing	Frequency of urine albumin-to-creatinine ratio (UACR) testing reported as counts and percentages of participants tested per monitoring period.	Average of 3 years
41. Echocardiography	Frequency of echocardiography abnormalities reported as counts and percentages	Average of 3 years
42. Electrocardiogram (ECG)	Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages	Average of 3 years
43. Participants Receiving Dietary Modification Counseling	Percentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.	Average of 3 years
44. Participants Enrolled in Exercise Programs	Percentage of participants enrolled in or recommended exercise programs reported as counts and percentages.	Average of 3 years
45. Participants Receiving Weight Management Interventions	Percentage of participants receiving weight management interventions or counseling reported as counts and percentages.	Average of 3 years
46. Participants Receiving Smoking Cessation Counseling	Percentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.	Average of 3 years
47. Participants Receiving Alcohol Reduction Counseling	Percentage of participants receiving alcohol reduction counseling or interventions reported as counts and percentages.	Average of 3 years
48. Percentage of Participants by Line of Treatment	Distribution of participants by line of pharmacological treatment (first-line, second-line, third-line or higher) reported as counts and percentages.	Average of 3 years
49. Percentage of Participants by Drug Class	Distribution of participants by drug class prescribed (e.g., SGLT2i, GLP-1RA, ACEi, ARBs, beta-blockers, MRAs, CCBs, diuretics, metformin, DPP-4i, sulfonylureas, insulin) reported as counts and percentages.	Average of 3 years
50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI)	Percentage of participants undergoing coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) reported as counts and percentages for each procedure type.	Average of 3 years
51. Percentage of Participants Receiving Dialysis	Percentage of participants receiving dialysis procedures (hemodialysis or peritoneal dialysis) reported as counts and percentages.	Average of 3 years
52. Percentage of Participants with Cardiac Device Implantation	Percentage of participants with cardiac device implantation (pacemaker, implantable cardioverter-defibrillator [ICD], or cardiac resynchronization therapy [CRT]) reported as counts and percentages for each device type.	Average of 3 years
53. Mean Duration of Pharmacological Treatments	Duration of pharmacological treatments reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in months for each drug class.	Average of 3 years
54. Drug Dose of Pharmacological Treatments	Drug dose of pharmacological treatments prescribed reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in milligrams (mg) for each drug class.	Average of 3 years
55. Number of Primary Care Visits per Participant	Total number of primary care visits reported as total visits and mean visits per participant ± standard deviation (SD).	Average of 3 years
56. Number of Tertiary Care Hospital Visits per Participant	Total number of tertiary care hospital visits reported as total visits and mean visits per participant ± standard deviation (SD).	Average of 3 years
57. Number of Specialist Care Visits per Participant	Total number of specialist care visits reported as total visits and mean visits per participant ± standard deviation (SD).	Average of 3 years
58.Number of Emergency Department Visits per Participant	Total number of emergency department visits reported as total visits and mean visits per participant ± standard deviation (SD).	Average of 3 years
59. All-Cause Hospitalizations	All-cause hospitalizations reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.	Average of 3 years
60. Disease-Specific Hospitalizations	Disease-specific hospitalizations (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.	Average of 3 years
61. All-Cause Emergency Department Visits	All-cause emergency department visits reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.	Average of 3 years
62. Disease-Specific Emergency Department Visits	Disease-specific emergency department visits (related to T2DM, HTN, HF, or CKD) reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.	Average of 3 years
63. Length of Hospital Stay	Length of hospital stay reported as median with interquartile range (IQR) and mean ± standard deviation (SD) in days.	Average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)	Hypoglycemic events defined as blood glucose <70 mg/dL (Level 1 - alert value) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.	Average of 3 years
2.Incidence of Level 2 Hypoglycemic Events (Blood Glucose <54 mg/dL)	Hypoglycemic events defined as blood glucose <54 mg/dL (Level 2 - clinically significant) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.	Average of 3 years
3.Incidence of Level 3 Hypoglycemic Events (Requiring Third-Party Assistance)	Severe hypoglycemic events requiring third-party assistance (Level 3) reported as counts, percentages of participants with at least one event, total number of events, and rate per 100 person-years.	Average of 3 years
4.Incidence of Diabetic Ketoacidosis (DKA) Episodes	Diabetic ketoacidosis (DKA) episodes reported as counts, percentages of participants with at least one episode, and total number of episodes.	Average of 3 years
5. Percentage of Participants with Uncontrolled Type 2 Diabetes (HbA1c ≥7%)	Percentage of participants with uncontrolled type 2 diabetes mellitus defined as HbA1c ≥7% reported as counts and percentages.	Average of 3 years
6. Percentage of Participants with Uncontrolled Hypertension (BP ≥140/90 mmHg)	Percentage of participants with uncontrolled hypertension defined as blood pressure ≥140/90 mmHg or ≥130/80 mmHg (per applicable guideline threshold) reported as counts and percentages.	Average of 3 years
7. Incidence of Retinopathy	Incidence of retinopathy reported as counts, percentages of participants with new-onset retinopathy, and incidence per 100 person-years.	Average of 3 years
8. Incidence of Nephropathy	Incidence of nephropathy reported as counts, percentages of participants with new-onset nephropathy, and incidence per 100 person-years.	Average of 3 years
9. Incidence of Neuropathy	Incidence of neuropathy reported as counts, percentages of participants with new-onset neuropathy, and incidence per 100 person-years.	Average of 3 years
10. Incidence of Myocardial Infarction (MI)	Incidence of myocardial infarction (MI) reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.	Average of 3 years
11. Incidence of Stroke	Incidence of stroke reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.	Average of 3 years
12. Incidence of Peripheral Arterial Disease (PAD)	Incidence of peripheral arterial disease (PAD) reported as counts, percentages of participants with new-onset PAD, and incidence per 100 person-years.	Average of 3 years
13. Incidence of Coronary Revascularization	Incidence of coronary revascularization procedures reported as counts, percentages of participants undergoing revascularization, and incidence per 100 person-years.	Average of 3 years
14. Incidence of New-Onset Heart Failure	Incidence of new-onset heart failure diagnosis reported as counts, percentages of participants with new HF diagnosis, and incidence per 100 person-years.	Average of 3 years
15. Incidence of New-Onset Chronic Kidney Disease	Incidence of new-onset chronic kidney disease defined as eGFR <60 mL/min/1.73m² or urine albumin-to-creatinine ratio (UACR) ≥30 mg/g reported as counts, percentages of participants, and incidence per 100 person-years.	Average of 3 years
16. Percentage of Participants Developing Anemia	Percentage of participants developing anemia as a cardio-renal complication reported as counts and percentages.	Average of 3 years
17. Percentage of Participants Developing Hyperkalemia	Percentage of participants developing hyperkalemia as a cardio-renal complication reported as counts and percentages.	Average of 3 years
18. Percentage of Participants with Heart Failure Hospitalization	Percentage of participants with at least one heart failure hospitalization reported as counts and percentages.	Average of 3 years
19. Percentage of Participants with eGFR Decline	Percentage of participants experiencing a clinically significant decline in estimated glomerular filtration rate (eGFR) reported as counts and percentages.	Average of 3 years
20. Percentage of Participants with RRT Initiation or ESRD Progression	Percentage of participants initiating renal replacement therapy (RRT) or progressing to end-stage renal disease (ESRD) reported as counts and percentages.	Average of 3 years
21. Incidence of Renal Replacement Therapy Initiation or ESRD Progression	Incidence of renal replacement therapy (RRT) initiation or progression to end-stage renal disease (ESRD) reported as counts, percentages of participants, and rate per 100 person-years.	Average of 3 years
22. Incidence of All-Cause Mortality	All-cause mortality reported as counts, percentages of participants, and rate per 100 person-years.	Average of 3 years
23. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Incidence of Hypoglycemic Events	Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and incidence of hypoglycemic events.	Average of 3 years
24. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled T2DM	Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled T2DM (HbA1c ≥7%).	Average of 3 years
26. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled HTN	Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and uncontrolled HTN (BP ≥140/90 mmHg).	Average of 3 years
27. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Heart Failure Worsening	Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and heart failure worsening.	Average of 3 years
28. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and CKD Progression/RRT Initiation/ESRD Progression	Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and CKD Progression/RRT Initiation/ESRD Progression	Average of 3 years
29. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and All-cause mortality	Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and All-cause mortality	Average of 3 years
30. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and and Myocardial Infarction/Stroke/PAD	Adjusted hazard ratios (HR) with 95% confidence intervals (CI) and p-values from multivariable regression models examining correlations between patient characteristics (age, sex, ethnicity, BMI, comorbidities), disease management (medication adherence, treatment intensification, lifestyle modifications), quality of care (treatment targets, monitoring frequency, guideline adherence), and Myocardial Infarction/Stroke/PAD	Average of 3 years
31. Correlation Between Patient Characteristics and Treatment Choices for T2DM	Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for T2DM (line of treatment and drug class: metformin, SGLT2i, GLP-1RA, DPP-4i, sulfonylureas, insulin).	Average of 3 years
32. Correlation Between Patient Characteristics and Treatment Choices for HTN	Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HTN (line of treatment and drug class: ACEi, ARBs, CCBs, beta-blockers, diuretics).	Average of 3 years
33. Correlation Between Patient Characteristics and Treatment Choices for HF	Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for HF (line of treatment and drug class: ACEi, ARBs, ARNI, beta-blockers, MRAs, SGLT2i).	Average of 3 years
34. Correlation Between Patient Characteristics and Treatment Choices for CKD	Adjusted odds ratios (OR) with 95% confidence intervals (CI) and p-values from multivariable logistic regression models examining correlations between socio-demographic/clinical characteristics (age, sex, ethnicity, education, insurance, disease severity, comorbidities, kidney/cardiac function, contraindications, intolerances) and treatment choices for CKD (line of treatment and drug class: ACEi, ARBs, SGLT2i).	Average of 3 years
35. Percentage of Participants with Dyslipidemia by Category	Distribution of participants with dyslipidemia by category reported as counts and percentages.	Average of 3 years
36. Percentage of Participants with Obesity by Category	Distribution of participants with obesity by BMI category reported as counts and percentages.	Average of 3 years
37. Percentage of Participants Achieving LDL-C Target <100 mg/dL	Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <100 mg/dL reported as counts and percentages.	Average of 3 years
38. Percentage of Participants Achieving LDL-C Target <70 mg/dL	Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of <70 mg/dL reported as counts and percentages.	Average of 3 years
40. Percentage of Participants Achieving Weight Loss ≥5%	Percentage of participants achieving weight loss of 5% or more from baseline reported as counts and percentages.	Average of 3 years
41. Percentage of Participants Achieving Weight Loss ≥10%	Percentage of participants achieving weight loss of 10% or more from baseline reported as counts and percentages.	Average of 3 years
42. Percentage of Participants Achieving Weight Loss ≥15%	Percentage of participants achieving weight loss of 15% or more from baseline reported as counts and percentages.	Average of 3 years
43. Percentage of Participants Developing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)	Percentage of participants developing metabolic dysfunction-associated steatotic liver disease (MASLD) as an obesity complication reported as counts and percentages.	Average of 3 years
44. Percentage of Participants Developing T2DM as an Obesity Complication	Percentage of participants developing new-onset type 2 diabetes mellitus (T2DM) as an obesity complication reported as counts and percentages.	Average of 3 years
45. Incidence of Myocardial Infarction/Stroke in Participants with Dyslipidemia/Obesity	Incidence of myocardial infarction (MI)/stroke in participants with dyslipidemia and/or obesity reported as counts and percentages.	Average of 3 years
46. Lipid levels in Participants with Dyslipidemia/Obesity	Total cholesterol, LDL-C, HDL-C, Triglyceride in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.	Average of 3 years
47. Body Weight in Participants with Dyslipidemia/Obesity	Body weight in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).	Average of 3 years
48. BMI in Participants with Dyslipidemia/Obesity	Body mass index (BMI) in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².	Average of 3 years
49. Waist Circumference in Participants with Dyslipidemia/Obesity	Waist circumference in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).	Average of 3 years
50. Waist-to-Hip Ratio in Participants with Dyslipidemia/Obesity	Waist-to-hip ratio in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).	Average of 3 years through
51. Frequency of Lipid Profile Monitoring in Participants with Dyslipidemia/Obesity	Frequency of lipid profile testing in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.	Average of 3 years
52. Frequency of Weight and BMI Monitoring in Participants with Dyslipidemia/Obesity	Frequency of weight and BMI measurements in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.	Average of 3 years
53. Frequency of Obesity Complication Assessments	Frequency of obesity complication assessments (screening for MASLD, T2DM, cardiovascular risk) reported as counts and percentages of participants assessed per clinical guidelines.	Average of 3 years
54. Percentage of Participants Receiving Lifestyle Modifications for Dyslipidemia/Obesity	Percentage of participants receiving lifestyle modification interventions (dietary, exercise, behavioral) for dyslipidemia and/or obesity management reported as counts and percentages.	Average of 3 years
55. Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications	Counts and Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications	Average of 3 years
56. Percentage of Participants Undergoing Bariatric Surgery	Percentage of participants undergoing bariatric surgery for obesity management reported as counts and percentages.	Average of 3 years
57. Mean Number of Visits for Dyslipidemia/Obesity	Number of visits for dyslipidemia and/or obesity management reported as counts and percentages of participants with at least one visit. Visits for dyslipidemia and/or obesity management reported as mean ± standard deviation (SD) and total visits.	Average of 3 years
58. Percentage of Participants Hospitalized for Dyslipidemia/Obesity	Percentage of participants with at least one hospitalization related to dyslipidemia and/or obesity reported as counts and percentages. Hospitalizations for dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and total hospitalizations.	Average of 3 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Hardik Vasnawala, MD, AstraZeneca; Study Director: Isidro Villanueva, MD, AstraZeneca; Study Director: Ahmed Hadaoui, PharmD, AstraZeneca

Publications and helpful links

General Publications

• Khunti K, Arici M, Pollock C, Huang CN, Silva-Tinoco R, Sayed AAE, Coto E, Salama K, Vasnawala H, Hadaoui A. Uncontrolled Hypertension in Cardio-Renal-Metabolic Diseases: Real-World Insights on Patient Profiles and Management Patterns From iCaReMe Global Registry. Int J Hypertens. 2026 Sep 3;2026:9668123. doi: 10.1155/ijhy/9668123. eCollection 2026.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2018
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 29, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Hypertension; Chronic Kidney Disease; Type 2 Diabetes; CKD; Registry; T2DM; HF; HTN; Adult population; Early cardiorenal complications
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Heart Failure; Hypertension; Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic
• Other Study ID Numbers: D1690R00044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No