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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03549754
Acronym
iCaReMe
Enrollment
35000
Registered
2018-06-08
Start date
2018-02-17
Completion date
2030-12-31
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Heart Failure, Hypertension, Type 2 Diabetes

Keywords

Registry, Type 2 Diabetes, T2DM, Chronic Kidney Disease, CKD, Hypertension, HTN, Adult population, Heart Failure, HF, Early cardiorenal complications

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

Interventions

None listed

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic ValuesAt BaselineHome blood pressure monitoring (HBPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic ValuesAt BaselineAmbulatory blood pressure monitoring (ABPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
28. Blood HbA1cAverage of 3 yearsHbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
29. Fasting GlucoseAverage of 3 yearsFasting Glucose reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
30. Lipid Profile TestingAverage of 3 yearsTotal cholesterol, LDL-C, HDL-C, triglycerides reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
31. Serum CreatinineAverage of 3 yearsSerum creatinine value reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL.
32. Estimated Glomerular Filtration Rate (eGFR)Average of 3 yearsEstimated glomerular filtration rate (eGFR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mL/min/1.73m².
33. Urine Albumin-to-Creatinine Ratio (UACR)Average of 3 yearsUrine albumin-to-creatinine ratio (UACR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/g.
34. Serum Electrolyte ValuesAvergae of 3 yearsSerum electrolyte values (sodium, potassium, chloride, bicarbonate) reported individually as mean ± standard deviation (SD) and median with interquartile range (IQR) in mmol/L.
35. Frequency of HbA1c TestingAverage of 3 yearsFrequency of glycated hemoglobin (HbA1c) testing reported as counts and percentages of participants tested per monitoring period.
36. Frequency of Fasting Glucose TestingAverage of 3 yearsFrequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.
37. Frequency of Lipid Profile TestingAverage of 3 yearsFrequency of lipid profile testing (total cholesterol, LDL-C, HDL-C, triglycerides) reported as counts and percentages of participants tested per monitoring period.
38. Frequency of Serum Creatinine TestingAverage of 3 yearsFrequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.
39. Frequency of eGFR AssessmentAverage of 3 yearsFrequency of estimated glomerular filtration rate (eGFR) assessment reported as counts and percentages of participants assessed per monitoring period.
40. Frequency of Urine Albumin-to-Creatinine Ratio TestingAverage of 3 yearsFrequency of urine albumin-to-creatinine ratio (UACR) testing reported as counts and percentages of participants tested per monitoring period.
41. EchocardiographyAverage of 3 yearsFrequency of echocardiography abnormalities reported as counts and percentages
42. Electrocardiogram (ECG)Average of 3 yearsFrequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
43. Participants Receiving Dietary Modification CounselingAverage of 3 yearsPercentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.
44. Participants Enrolled in Exercise ProgramsAverage of 3 yearsPercentage of participants enrolled in or recommended exercise programs reported as counts and percentages.
45. Participants Receiving Weight Management InterventionsAverage of 3 yearsPercentage of participants receiving weight management interventions or counseling reported as counts and percentages.
46. Participants Receiving Smoking Cessation CounselingAverage of 3 yearsPercentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.
47. Participants Receiving Alcohol Reduction CounselingAverage of 3 yearsPercentage of participants receiving alcohol reduction counseling or interventions reported as counts and percentages.
1. Age of particpantsAt BaselineAge of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
2. Percentage of Participants by SexAt baselineDistribution of participants by sex (male/female) reported as counts and percentages.
3. Percentage of Participants by EthnicityAt BaselineDistribution of participants by ethnicity reported as counts and percentages for each ethnic category.
4. Percentage of Participants by Education LevelAt BaselineDistribution of participants by education level reported as counts and percentages for each education category.
5. Percentage of Participants by Marital StatusAt BaselineDistribution of participants by marital status reported as counts and percentages for each marital status category.
6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic DiseaseAt BaselinePercentage of participants with a family history of cardiovascular, renal, or metabolic (CVRM) disease (yes/no) reported as counts and percentages.
7.Percentage of Participants by Physical Activity LevelAt BaselineDistribution of participants by physical activity level category reported as counts and percentages.
8. Percentage of Participants by Smoking StatusAt BaselineDistribution of participants by smoking status (current smoker/former smoker/never smoked) reported as counts and percentages.
9. Percentage of Participants by Alcohol ConsumptionAt BaselineDistribution of participants by alcohol consumption category reported as counts and percentages.
10. Body Weight of ParticipantsAt BaselineBody weight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
11. Height of ParticipantsAt BaselineHeight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in meters (m).
12. Body Mass Index (BMI) of ParticipantsAt BaselineBody mass index (BMI), calculated from weight and height, reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
48. Percentage of Participants by Line of TreatmentAverage of 3 yearsDistribution of participants by line of pharmacological treatment (first-line, second-line, third-line or higher) reported as counts and percentages.
49. Percentage of Participants by Drug ClassAverage of 3 yearsDistribution 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.
50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI)Average of 3 yearsPercentage of participants undergoing coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) reported as counts and percentages for each procedure type.
51. Percentage of Participants Receiving DialysisAverage of 3 yearsPercentage of participants receiving dialysis procedures (hemodialysis or peritoneal dialysis) reported as counts and percentages.
52. Percentage of Participants with Cardiac Device ImplantationAverage of 3 yearsPercentage 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.
53. Mean Duration of Pharmacological TreatmentsAverage of 3 yearsDuration of pharmacological treatments reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in months for each drug class.
54. Drug Dose of Pharmacological TreatmentsAverage of 3 yearsDrug dose of pharmacological treatments prescribed reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in milligrams (mg) for each drug class.
55. Number of Primary Care Visits per ParticipantAverage of 3 yearsTotal number of primary care visits reported as total visits and mean visits per participant ± standard deviation (SD).
56. Number of Tertiary Care Hospital Visits per ParticipantAverage of 3 yearsTotal number of tertiary care hospital visits reported as total visits and mean visits per participant ± standard deviation (SD).
57. Number of Specialist Care Visits per ParticipantAverage of 3 yearsTotal number of specialist care visits reported as total visits and mean visits per participant ± standard deviation (SD).
58.Number of Emergency Department Visits per ParticipantAverage of 3 yearsTotal number of emergency department visits reported as total visits and mean visits per participant ± standard deviation (SD).
59. All-Cause HospitalizationsAverage of 3 yearsAll-cause hospitalizations reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
60. Disease-Specific HospitalizationsAverage of 3 yearsDisease-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.
61. All-Cause Emergency Department VisitsAverage of 3 yearsAll-cause emergency department visits reported as counts, percentages of participants with at least one visit, total visits, and rate per 100 person-years.
62. Disease-Specific Emergency Department VisitsAverage of 3 yearsDisease-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.
63. Length of Hospital StayAverage of 3 yearsLength of hospital stay reported as median with interquartile range (IQR) and mean ± standard deviation (SD) in days.
14. Waist-to-Hip Ratio of ParticipantsAt BaselineWaist-to-hip ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
15. Waist-to-Height Ratio of ParticipantsAt BaselineWaist-to-height ratio of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
16. Percentage of Participants by Cardiac and Renal Functional Measurements CategoryAt BaselineDistribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
17. Primary Disease DurationAt BaselineDuration 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.
18. Percentage of Participants by Number and Types of ComorbiditiesAt BaselineDistribution of participants by number and types of comorbidities reported as counts and percentages for each comorbidity category.
13. Waist Circumference of ParticipantsAt BaselineWaist circumference of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
19. Percentage of Participants by NYHA Functional ClassAt BaselineDistribution of heart failure participants by New York Heart Association (NYHA) functional class (I, II, III, IV) reported as counts and percentages.
20. Percentage of Participants by Heart Failure PhenotypeAt BaselineDistribution of heart failure participants by phenotype (HFrEF: ejection fraction ≤40%, HFmrEF: 41-49%, HFpEF: ≥50%) reported as counts and percentages.
21. Percentage of Participants by Heart Failure EtiologyAt BaselineDistribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.
22. Percentage of Participants by CKD EtiologyAt BaselineDistribution of chronic kidney disease participants by etiology (diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, other) reported as counts and percentages.
23. Percentage of Participants by Hypertension StageAt BaselineDistribution of hypertension participants by stage (Stage 1, Stage 2, Stage 3) reported as counts and percentages.
24. Percentage of Participants by Secondary Hypertension EtiologyAt BaselineDistribution of participants with secondary hypertension by etiology reported as counts and percentages for each etiology category.
25. Office Systolic and Diastolic Blood PressureAt BaselineOffice blood pressure reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.

Secondary

MeasureTime frameDescription
58. Percentage of Participants Hospitalized for Dyslipidemia/ObesityAverage of 3 yearsPercentage 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.
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)Average of 3 yearsHypoglycemic 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.
2.Incidence of Level 2 Hypoglycemic Events (Blood Glucose <54 mg/dL)Average of 3 yearsHypoglycemic 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.
3.Incidence of Level 3 Hypoglycemic Events (Requiring Third-Party Assistance)Average of 3 yearsSevere 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.
4.Incidence of Diabetic Ketoacidosis (DKA) EpisodesAverage of 3 yearsDiabetic ketoacidosis (DKA) episodes reported as counts, percentages of participants with at least one episode, and total number of episodes.
5. Percentage of Participants with Uncontrolled Type 2 Diabetes (HbA1c ≥7%)Average of 3 yearsPercentage of participants with uncontrolled type 2 diabetes mellitus defined as HbA1c ≥7% reported as counts and percentages.
6. Percentage of Participants with Uncontrolled Hypertension (BP ≥140/90 mmHg)Average of 3 yearsPercentage 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.
7. Incidence of RetinopathyAverage of 3 yearsIncidence of retinopathy reported as counts, percentages of participants with new-onset retinopathy, and incidence per 100 person-years.
8. Incidence of NephropathyAverage of 3 yearsIncidence of nephropathy reported as counts, percentages of participants with new-onset nephropathy, and incidence per 100 person-years.
9. Incidence of NeuropathyAverage of 3 yearsIncidence of neuropathy reported as counts, percentages of participants with new-onset neuropathy, and incidence per 100 person-years.
10. Incidence of Myocardial Infarction (MI)Average of 3 yearsIncidence of myocardial infarction (MI) reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
11. Incidence of StrokeAverage of 3 yearsIncidence of stroke reported as counts, percentages of participants with at least one event, and incidence per 100 person-years.
12. Incidence of Peripheral Arterial Disease (PAD)Average of 3 yearsIncidence of peripheral arterial disease (PAD) reported as counts, percentages of participants with new-onset PAD, and incidence per 100 person-years.
13. Incidence of Coronary RevascularizationAverage of 3 yearsIncidence of coronary revascularization procedures reported as counts, percentages of participants undergoing revascularization, and incidence per 100 person-years.
14. Incidence of New-Onset Heart FailureAverage of 3 yearsIncidence of new-onset heart failure diagnosis reported as counts, percentages of participants with new HF diagnosis, and incidence per 100 person-years.
15. Incidence of New-Onset Chronic Kidney DiseaseAverage of 3 yearsIncidence 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.
16. Percentage of Participants Developing AnemiaAverage of 3 yearsPercentage of participants developing anemia as a cardio-renal complication reported as counts and percentages.
17. Percentage of Participants Developing HyperkalemiaAverage of 3 yearsPercentage of participants developing hyperkalemia as a cardio-renal complication reported as counts and percentages.
18. Percentage of Participants with Heart Failure HospitalizationAverage of 3 yearsPercentage of participants with at least one heart failure hospitalization reported as counts and percentages.
19. Percentage of Participants with eGFR DeclineAverage of 3 yearsPercentage of participants experiencing a clinically significant decline in estimated glomerular filtration rate (eGFR) reported as counts and percentages.
20. Percentage of Participants with RRT Initiation or ESRD ProgressionAverage of 3 yearsPercentage of participants initiating renal replacement therapy (RRT) or progressing to end-stage renal disease (ESRD) reported as counts and percentages.
21. Incidence of Renal Replacement Therapy Initiation or ESRD ProgressionAverage of 3 yearsIncidence 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.
22. Incidence of All-Cause MortalityAverage of 3 yearsAll-cause mortality reported as counts, percentages of participants, and rate per 100 person-years.
23. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Incidence of Hypoglycemic EventsAverage of 3 yearsAdjusted 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.
24. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled T2DMAverage of 3 yearsAdjusted 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%).
45. Incidence of Myocardial Infarction/Stroke in Participants with Dyslipidemia/ObesityAverage of 3 yearsIncidence of myocardial infarction (MI)/stroke in participants with dyslipidemia and/or obesity reported as counts and percentages.
46. Lipid levels in Participants with Dyslipidemia/ObesityAverage of 3 yearsTotal 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.
47. Body Weight in Participants with Dyslipidemia/ObesityAverage of 3 yearsBody weight in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
48. BMI in Participants with Dyslipidemia/ObesityAverage of 3 yearsBody 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.
49. Waist Circumference in Participants with Dyslipidemia/ObesityAverage of 3 yearsWaist circumference in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
50. Waist-to-Hip Ratio in Participants with Dyslipidemia/ObesityAverage of 3 years throughWaist-to-hip ratio in participants with dyslipidemia and/or obesity reported as mean ± standard deviation (SD) and median with interquartile range (IQR) (unitless ratio).
51. Frequency of Lipid Profile Monitoring in Participants with Dyslipidemia/ObesityAverage of 3 yearsFrequency of lipid profile testing in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
52. Frequency of Weight and BMI Monitoring in Participants with Dyslipidemia/ObesityAverage of 3 yearsFrequency of weight and BMI measurements in participants with dyslipidemia and/or obesity reported as counts and percentages of participants monitored per clinical guidelines.
53. Frequency of Obesity Complication AssessmentsAverage of 3 yearsFrequency of obesity complication assessments (screening for MASLD, T2DM, cardiovascular risk) reported as counts and percentages of participants assessed per clinical guidelines.
54. Percentage of Participants Receiving Lifestyle Modifications for Dyslipidemia/ObesityAverage of 3 yearsPercentage of participants receiving lifestyle modification interventions (dietary, exercise, behavioral) for dyslipidemia and/or obesity management reported as counts and percentages.
26. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Uncontrolled HTNAverage of 3 yearsAdjusted 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).
27. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and Heart Failure WorseningAverage of 3 yearsAdjusted 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.
28. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and CKD Progression/RRT Initiation/ESRD ProgressionAverage of 3 yearsAdjusted 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
29. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and All-cause mortalityAverage of 3 yearsAdjusted 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
30. Correlation Between Patient Characteristics, Disease Management, Quality of Care, and and Myocardial Infarction/Stroke/PADAverage of 3 yearsAdjusted 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
31. Correlation Between Patient Characteristics and Treatment Choices for T2DMAverage of 3 yearsAdjusted 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).
32. Correlation Between Patient Characteristics and Treatment Choices for HTNAverage of 3 yearsAdjusted 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).
33. Correlation Between Patient Characteristics and Treatment Choices for HFAverage of 3 yearsAdjusted 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).
34. Correlation Between Patient Characteristics and Treatment Choices for CKDAverage of 3 yearsAdjusted 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).
35. Percentage of Participants with Dyslipidemia by CategoryAverage of 3 yearsDistribution of participants with dyslipidemia by category reported as counts and percentages.
36. Percentage of Participants with Obesity by CategoryAverage of 3 yearsDistribution of participants with obesity by BMI category reported as counts and percentages.
37. Percentage of Participants Achieving LDL-C Target <100 mg/dLAverage of 3 yearsPercentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of \<100 mg/dL reported as counts and percentages.
38. Percentage of Participants Achieving LDL-C Target <70 mg/dLAverage of 3 yearsPercentage of participants achieving low-density lipoprotein cholesterol (LDL-C) target of \<70 mg/dL reported as counts and percentages.
40. Percentage of Participants Achieving Weight Loss ≥5%Average of 3 yearsPercentage of participants achieving weight loss of 5% or more from baseline reported as counts and percentages.
41. Percentage of Participants Achieving Weight Loss ≥10%Average of 3 yearsPercentage of participants achieving weight loss of 10% or more from baseline reported as counts and percentages.
42. Percentage of Participants Achieving Weight Loss ≥15%Average of 3 yearsPercentage of participants achieving weight loss of 15% or more from baseline reported as counts and percentages.
43. Percentage of Participants Developing Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Average of 3 yearsPercentage of participants developing metabolic dysfunction-associated steatotic liver disease (MASLD) as an obesity complication reported as counts and percentages.
44. Percentage of Participants Developing T2DM as an Obesity ComplicationAverage of 3 yearsPercentage of participants developing new-onset type 2 diabetes mellitus (T2DM) as an obesity complication reported as counts and percentages.
55. Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity MedicationsAverage of 3 yearsCounts and Percentage of Participants Receiving Statins/Ezetimibe/PCSK9 Inhibitors/Fibrates/Omega-3 Farry Acids/GLP-1 Receptor Agonists for Obesity/ other Anti-Obesity Medications
56. Percentage of Participants Undergoing Bariatric SurgeryAverage of 3 yearsPercentage of participants undergoing bariatric surgery for obesity management reported as counts and percentages.
57. Mean Number of Visits for Dyslipidemia/ObesityAverage of 3 yearsNumber 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.

Countries

Brazil, Chile, Costa Rica, Côte d’Ivoire, Egypt, Georgia, Ghana, Hong Kong, India, Iraq, Kazakhstan, Kenya, Malaysia, Mexico, Nigeria, Philippines, South Africa, Taiwan, Ukraine, United Arab Emirates

Contacts

CONTACTAstraZeneca Clinical Study Information Center
information.center@astrazeneca.com1-877-240-9479
STUDY_DIRECTORHardik Vasnawala, MD

AstraZeneca

STUDY_DIRECTORIsidro Villanueva, MD

AstraZeneca

STUDY_DIRECTORAhmed Hadaoui, PharmD

AstraZeneca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026