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

Condition(s) studied

Study 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

Eligibility

Primary outcome measure(s)

• 1. Age of particpants — At Baseline
  Age of participants at enrollment reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in years.
• 2. Percentage of Participants by Sex — At baseline
  Distribution of participants by sex (male/female) reported as counts and percentages.
• 3. Percentage of Participants by Ethnicity — At Baseline
  Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.
• 4. Percentage of Participants by Education Level — At Baseline
  Distribution of participants by education level reported as counts and percentages for each education category.
• 5. Percentage of Participants by Marital Status — At Baseline
  Distribution 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 Disease — At Baseline
  Percentage 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 Level — At Baseline
  Distribution of participants by physical activity level category reported as counts and percentages.
• 8. Percentage of Participants by Smoking Status — At Baseline
  Distribution of participants by smoking status (current smoker/former smoker/never smoked) reported as counts and percentages.
• 9. Percentage of Participants by Alcohol Consumption — At Baseline
  Distribution of participants by alcohol consumption category reported as counts and percentages.
• 10. Body Weight of Participants — At Baseline
  Body weight of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kilograms (kg).
• 11. Height of Participants — At Baseline
  Height of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in meters (m).
• 12. Body Mass Index (BMI) of Participants — At Baseline
  Body mass index (BMI), calculated from weight and height, reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in kg/m².
• 13. Waist Circumference of Participants — At Baseline
  Waist circumference of participants reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in centimeters (cm).
• 14. Waist-to-Hip Ratio of Participants — At Baseline
  Waist-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 Participants — At Baseline
  Waist-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 Category — At Baseline
  Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
• 17. Primary Disease Duration — At Baseline
  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.
• 18. Percentage of Participants by Number and Types of Comorbidities — At Baseline
  Distribution of participants by number and types of comorbidities reported as counts and percentages for each comorbidity category.
• 19. Percentage of Participants by NYHA Functional Class — At Baseline
  Distribution 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 Phenotype — At Baseline
  Distribution 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 Etiology — At Baseline
  Distribution of heart failure participants by etiology (ischemic, non-ischemic, valvular, hypertensive, other) reported as counts and percentages.
• 22. Percentage of Participants by CKD Etiology — At Baseline
  Distribution of chronic kidney disease participants by etiology (diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, other) reported as counts and percentages.
• 23. Percentage of Participants by Hypertension Stage — At Baseline
  Distribution of hypertension participants by stage (Stage 1, Stage 2, Stage 3) reported as counts and percentages.
• 24. Percentage of Participants by Secondary Hypertension Etiology — At Baseline
  Distribution of participants with secondary hypertension by etiology reported as counts and percentages for each etiology category.
• 25. Office Systolic and Diastolic Blood Pressure — At Baseline
  Office blood pressure reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
• 26. Home Blood Pressure Monitoring (HBPM) Systolic and Diastolic Values — At Baseline
  Home 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 Values — At Baseline
  Ambulatory blood pressure monitoring (ABPM) values reported as mean systolic blood pressure ± standard deviation (SD) and mean diastolic blood pressure ± SD in mmHg.
• 28. Blood HbA1c — Average of 3 years
  HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
• 29. Fasting Glucose — Average of 3 years
  Fasting Glucose reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
• 30. Lipid Profile Testing — Average of 3 years
  Total cholesterol, LDL-C, HDL-C, triglycerides reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/dL
• 31. Serum Creatinine — Average of 3 years
  Serum 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 years
  Estimated 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 years
  Urine albumin-to-creatinine ratio (UACR) reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in mg/g.
• 34. Serum Electrolyte Values — Avergae of 3 years
  Serum 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 Testing — Average of 3 years
  Frequency of glycated hemoglobin (HbA1c) testing reported as counts and percentages of participants tested per monitoring period.
• 36. Frequency of Fasting Glucose Testing — Average of 3 years
  Frequency of fasting glucose testing reported as counts and percentages of participants tested per monitoring period.
• 37. Frequency of Lipid Profile Testing — Average of 3 years
  Frequency 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 Testing — Average of 3 years
  Frequency of serum creatinine testing reported as counts and percentages of participants tested per monitoring period.
• 39. Frequency of eGFR Assessment — Average of 3 years
  Frequency 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 Testing — Average of 3 years
  Frequency of urine albumin-to-creatinine ratio (UACR) testing reported as counts and percentages of participants tested per monitoring period.
• 41. Echocardiography — Average of 3 years
  Frequency of echocardiography abnormalities reported as counts and percentages
• 42. Electrocardiogram (ECG) — Average of 3 years
  Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
• 43. Participants Receiving Dietary Modification Counseling — Average of 3 years
  Percentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.
• 44. Participants Enrolled in Exercise Programs — Average of 3 years
  Percentage of participants enrolled in or recommended exercise programs reported as counts and percentages.
• 45. Participants Receiving Weight Management Interventions — Average of 3 years
  Percentage of participants receiving weight management interventions or counseling reported as counts and percentages.
• 46. Participants Receiving Smoking Cessation Counseling — Average of 3 years
  Percentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.
• 47. Participants Receiving Alcohol Reduction Counseling — Average of 3 years
  Percentage of participants receiving alcohol reduction counseling or interventions reported as counts and percentages.
• 48. Percentage of Participants by Line of Treatment — Average of 3 years
  Distribution 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 Class — Average of 3 years
  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.
• 50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI) — Average of 3 years
  Percentage 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 Dialysis — Average of 3 years
  Percentage of participants receiving dialysis procedures (hemodialysis or peritoneal dialysis) reported as counts and percentages.
• 52. Percentage of Participants with Cardiac Device Implantation — Average of 3 years
  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.
• 53. Mean Duration of Pharmacological Treatments — Average of 3 years
  Duration 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 Treatments — Average of 3 years
  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.
• 55. Number of Primary Care Visits per Participant — Average of 3 years
  Total 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 Participant — Average of 3 years
  Total 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 Participant — Average of 3 years
  Total number of specialist care visits reported as total visits and mean visits per participant ± standard deviation (SD).
• 58.Number of Emergency Department Visits per Participant — Average of 3 years
  Total number of emergency department visits reported as total visits and mean visits per participant ± standard deviation (SD).
• 59. All-Cause Hospitalizations — Average of 3 years
  All-cause hospitalizations reported as counts, percentages of participants with at least one hospitalization, total hospitalizations, and rate per 100 person-years.
• 60. Disease-Specific Hospitalizations — Average of 3 years
  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.
• 61. All-Cause Emergency Department Visits — Average of 3 years
  All-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 Visits — Average of 3 years
  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.
• 63. Length of Hospital Stay — Average of 3 years
  Length of hospital stay reported as median with interquartile range (IQR) and mean ± standard deviation (SD) in days.

Trial sites (76)

+ 36 more sites — see the full list on the official registry below.

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