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iCaReMe Global Registry (iCaReMe)

7. September 2026 aktualisiert von: AstraZeneca

Multinationales Register aus der realen Welt zur Bestimmung des Managements und der Qualität der Versorgung von Patienten mit Typ-2-Diabetes, Bluthochdruck, Herzinsuffizienz und/oder chronischen Nierenerkrankungen

Bereitstellung von Daten aus der realen Welt zu Patientenmerkmalen, Krankheitsmanagement, Inanspruchnahme der Gesundheitsversorgung und Ergebnissen bei Patienten mit Typ-2-Diabetes, Bluthochdruck, Herzinsuffizienz und/oder chronischen Nierenerkrankungen

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

Das Register soll reale Daten zum Patientenmanagement und zur Qualität der Versorgung von Patienten mit T2DM, Bluthochdruck, Hitzeversagen und chronischer Nierenerkrankung in der klinischen Praxis in vielen Ländern bereitstellen. Um diese Lücke zu schließen, wird ein freiwilliges Beobachtungsregister eingerichtet, um reale Daten zu Patientenmerkmalen, Krankheitsmanagement, Inanspruchnahme der Gesundheitsversorgung und Ergebnissen bei Patienten mit Typ-2-Diabetes, Bluthochdruck, Herzinsuffizienz und chronischer Nierenerkrankung zu erfassen. Multinationales Beobachtungsregister unter Verwendung eines Cloud-basierten eCRF für die prospektive und retrospektive Datenerfassung, zugänglich für Ermittler und den wissenschaftlichen Ausschuss. Dieses Register steht allen Ärzten weltweit offen, die T2DM, HTN, HF oder CKD behandeln.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

35000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Brasilien
      • São Paulo, Brasilien, 05403-000
        • Rekrutierung
        • Research Site
      • São Paulo, Brasilien, 05403-900
        • Rekrutierung
        • Research Site
    • Ceará
      • Fortaleza, Ceará, Brasilien, 60840-285
        • Rekrutierung
        • Research Site
    • Espírito Santo (ES)
      • Colatina, Espírito Santo (ES), Brasilien, 29707-035
        • Rekrutierung
        • Research Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brasilien, 40730-220
        • Rekrutierung
        • Research Site
    • Federal District
      • Brasília, Federal District, Brasilien, 70673-623
        • Rekrutierung
        • Research Site
    • Minas Gerais
      • Poços de Caldas, Minas Gerais, Brasilien, 37706-106
        • Rekrutierung
        • Research Site
    • Paraná
      • Campina Grande do Sul, Paraná, Brasilien, 83430-000
        • Rekrutierung
        • Research Site
      • Curitiba, Paraná, Brasilien, 80230-020
        • Rekrutierung
        • Research Site
    • Piauí (PI)
      • Teresina, Piauí (PI), Brasilien, 64001-450
        • Rekrutierung
        • Research Site
    • Rio Grande Do Sul (RS)
      • Santa Cruz do Sul, Rio Grande Do Sul (RS), Brasilien, 96835-090
        • Rekrutierung
        • Research Site
    • State of Goias
      • Goiânia, State of Goias, Brasilien, 74453-200
        • Rekrutierung
        • Research Site
    • State of Santa Catarina
      • Joinville, State of Santa Catarina, Brasilien, 89204-248
        • Rekrutierung
        • Research Site
    • São Paulo
      • Bragança Paulista, São Paulo, Brasilien, 12916-542
        • Rekrutierung
        • Research Site
      • São Caetano do Sul, São Paulo, Brasilien, 09521-160
        • Rekrutierung
        • Research Site
  • Chile
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500922
        • Rekrutierung
        • Research Site
  • Costa Rica
      • San José, Costa Rica
        • Rekrutierung
        • Research Site
  • Côte d'Ivoire
      • Abidjan, Côte d'Ivoire
        • Rekrutierung
        • Research Site
  • Georgia
      • Tbilisi, Georgia
        • Rekrutierung
        • Research Site
  • Ghana
      • Kumasi, Ghana
        • Rekrutierung
        • Research Site
  • Hongkong
      • Wan Chai, Hongkong
        • Rekrutierung
        • Research Site
  • Indien
      • Ahmedabad, Indien
        • Rekrutierung
        • Research Site
      • Kolkata, Indien, 700034
        • Rekrutierung
        • Research Site
      • Mumbai, Indien, 400006
        • Rekrutierung
        • Research Site
  • Irak
      • Sulaymaniyah, Irak, 46001
        • Rekrutierung
        • Research Site
  • Kasachstan
      • Aktobe, Kasachstan, 30019
        • Rekrutierung
        • Research Site
      • Almaty, Kasachstan, 50000
        • Rekrutierung
        • Research Site
      • Almaty, Kasachstan, 50006
        • Rekrutierung
        • Research Site
      • Almaty, Kasachstan, 50012
        • Rekrutierung
        • Research Site
      • Almaty, Kasachstan, 50054
        • Rekrutierung
        • Research Site
  • Kenia
      • Nairobi, Kenia, 14497
        • Rekrutierung
        • Research Site
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Rekrutierung
        • Research Site
  • Mexiko
      • Iztapalapa, Mexiko
        • Rekrutierung
        • Research Site
      • Mexico City, Mexiko, 06720
        • Rekrutierung
        • Research Site
      • Mexico City, Mexiko
        • Rekrutierung
        • Research Site
      • México, Mexiko, 04530
        • Rekrutierung
        • Research Site
    • Guanajuato
      • León, Guanajuato, Mexiko, 37549
        • Rekrutierung
        • Research Site
  • Nigeria
      • Enugu, Nigeria, 400001
        • Rekrutierung
        • Research Site
      • Gwagwalada, Nigeria, 901002
        • Rekrutierung
        • Research Site
      • Kano, Nigeria, 700233
        • Rekrutierung
        • Research Site
  • Philippinen
      • Bulacan, Philippinen
        • Noch keine Rekrutierung
        • Research Site
      • Cebu City, Philippinen
        • Rekrutierung
        • Research Site
      • Iloilo City, Philippinen
        • Noch keine Rekrutierung
        • Research Site
      • Laguna, Philippinen
        • Noch keine Rekrutierung
        • Research Site
      • Mandaluyong, Philippinen
        • Noch keine Rekrutierung
        • Research Site
      • Manila, Philippinen
        • Noch keine Rekrutierung
        • Research Site
      • Mindoro, Philippinen
        • Noch keine Rekrutierung
        • Research Site
      • Pampanga, Philippinen
        • Noch keine Rekrutierung
        • Research Site
      • Quezon City, Philippinen
        • Noch keine Rekrutierung
        • Research Site
      • Zamboanga City, Philippinen
        • Noch keine Rekrutierung
        • Research Site
  • Südafrika
      • Florida, Südafrika, 1794
        • Rekrutierung
        • Research Site
      • Parow, Südafrika, 7505
        • Rekrutierung
        • Research Site
      • Umhlanga, Südafrika, 4320
        • Rekrutierung
        • Research Site
      • Umhlanga, Südafrika, 4319
        • Rekrutierung
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500209
        • Rekrutierung
        • Research Site
      • Kaohsiung City, Taiwan, 81301
        • Rekrutierung
        • Research Site
      • Niaosong, Taiwan, 83301
        • Rekrutierung
        • Research Site
      • Taichung, Taiwan, 40447
        • Rekrutierung
        • Research Site
      • Taichung, Taiwan, 40705
        • Rekrutierung
        • Research Site
      • Taichung, Taiwan
        • Rekrutierung
        • Research Site
      • Tainan, Taiwan, 704
        • Rekrutierung
        • Research Site
      • Taipei, Taiwan
        • Rekrutierung
        • Research Site
      • Taoyuan City, Taiwan, 33305
        • Rekrutierung
        • Research Site
  • Ukraine
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49005
        • Rekrutierung
        • Research Site
    • Kharkiv Oblast
      • Kharkiv, Kharkiv Oblast, Ukraine, 61039
        • Rekrutierung
        • Research Site
      • Kharkiv, Kharkiv Oblast, Ukraine
        • Rekrutierung
        • Research Site
    • Kyiv Oblast
      • Kyiv, Kyiv Oblast, Ukraine, 3039
        • Rekrutierung
        • Research Site
      • Kyiv, Kyiv Oblast, Ukraine, 4050
        • Rekrutierung
        • Research Site
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21000
        • Rekrutierung
        • Research Site
    • Volyn Oblast
      • Lutsk, Volyn Oblast, Ukraine, 43024
        • Rekrutierung
        • Research Site
    • Zakarpattia Oblast
      • Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
        • Rekrutierung
        • Research Site
    • Zaporizhzhia Oblast
      • Zaporizhzhya, Zaporizhzhia Oblast, Ukraine, 69035
        • Rekrutierung
        • Research Site
  • Vereinigte Arabische Emirate
      • Sharjah city, Vereinigte Arabische Emirate
        • Rekrutierung
        • Research Site
  • Ägypten
      • Alexandria, Ägypten
        • Rekrutierung
        • Research Site
      • Cairo, Ägypten
        • Rekrutierung
        • Research Site
      • Giza, Ägypten
        • Rekrutierung
        • Research Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Erwachsene mit Typ-2-Diabetes, Bluthochdruck, Herzinsuffizienz und/oder chronischer Nierenerkrankung

Beschreibung

Einschlusskriterien:

  1. 18 Jahre oder älter sein
  2. Typ-2-Diabetes, Bluthochdruck, Herzinsuffizienz und/oder chronische Nierenerkrankung haben
  3. Bereitstellen einer schriftlichen Einverständniserklärung zur Teilnahme am Register

Ausschlusskriterien:

  1. Eine lebensbedrohliche Komorbidität mit einer Lebenserwartung von weniger als 1 Jahr haben
  2. Teilnahme an einer interventionellen Studie, die eine Einverständniserklärung erfordert

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Sonstiges
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
1. Age of particpants
Zeitfenster: At Baseline
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
Zeitfenster: At baseline
Distribution of participants by sex (male/female) reported as counts and percentages.
At baseline
3. Percentage of Participants by Ethnicity
Zeitfenster: At Baseline
Distribution of participants by ethnicity reported as counts and percentages for each ethnic category.
At Baseline
4. Percentage of Participants by Education Level
Zeitfenster: At Baseline
Distribution of participants by education level reported as counts and percentages for each education category.
At Baseline
5. Percentage of Participants by Marital Status
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
Distribution of participants by physical activity level category reported as counts and percentages.
At Baseline
8. Percentage of Participants by Smoking Status
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
Distribution of participants by alcohol consumption category reported as counts and percentages.
At Baseline
10. Body Weight of Participants
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: 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.
At Baseline
13. Waist Circumference of Participants
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
At Baseline
17. Primary Disease Duration
Zeitfenster: 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.
At Baseline
18. Percentage of Participants by Number and Types of Comorbidities
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: At Baseline
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
Zeitfenster: 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.
At Baseline
27. Ambulatory Blood Pressure Monitoring (ABPM) Systolic and Diastolic Values
Zeitfenster: 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.
At Baseline
28. Blood HbA1c
Zeitfenster: Average of 3 years
HbA1c values reported as mean ± standard deviation (SD) and median with interquartile range (IQR) in %
Average of 3 years
29. Fasting Glucose
Zeitfenster: Average of 3 years
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
Zeitfenster: 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
Average of 3 years
31. Serum Creatinine
Zeitfenster: Average of 3 years
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)
Zeitfenster: 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.
Average of 3 years
33. Urine Albumin-to-Creatinine Ratio (UACR)
Zeitfenster: 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.
Average of 3 years
34. Serum Electrolyte Values
Zeitfenster: 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.
Avergae of 3 years
35. Frequency of HbA1c Testing
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: 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.
Average of 3 years
38. Frequency of Serum Creatinine Testing
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
Frequency of echocardiography abnormalities reported as counts and percentages
Average of 3 years
42. Electrocardiogram (ECG)
Zeitfenster: Average of 3 years
Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
Average of 3 years
43. Participants Receiving Dietary Modification Counseling
Zeitfenster: Average of 3 years
Percentage of participants receiving dietary modification counseling or intervention reported as counts and percentages.
Average of 3 years
44. Participants Enrolled in Exercise Programs
Zeitfenster: Average of 3 years
Percentage of participants enrolled in or recommended exercise programs reported as counts and percentages.
Average of 3 years
45. Participants Receiving Weight Management Interventions
Zeitfenster: Average of 3 years
Percentage of participants receiving weight management interventions or counseling reported as counts and percentages.
Average of 3 years
46. Participants Receiving Smoking Cessation Counseling
Zeitfenster: Average of 3 years
Percentage of participants receiving smoking cessation counseling or interventions reported as counts and percentages.
Average of 3 years
47. Participants Receiving Alcohol Reduction Counseling
Zeitfenster: Average of 3 years
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
Zeitfenster: 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.
Average of 3 years
49. Percentage of Participants by Drug Class
Zeitfenster: 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.
Average of 3 years
50. Percentage of Participants Undergoing Cardiac Surgeries (CABG or PCI)
Zeitfenster: 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.
Average of 3 years
51. Percentage of Participants Receiving Dialysis
Zeitfenster: Average of 3 years
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
Zeitfenster: 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.
Average of 3 years
53. Mean Duration of Pharmacological Treatments
Zeitfenster: 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.
Average of 3 years
54. Drug Dose of Pharmacological Treatments
Zeitfenster: 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.
Average of 3 years
55. Number of Primary Care Visits per Participant
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: 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.
Average of 3 years
60. Disease-Specific Hospitalizations
Zeitfenster: 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.
Average of 3 years
61. All-Cause Emergency Department Visits
Zeitfenster: 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.
Average of 3 years
62. Disease-Specific Emergency Department Visits
Zeitfenster: 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.
Average of 3 years
63. Length of Hospital Stay
Zeitfenster: Average of 3 years
Length of hospital stay reported as median with interquartile range (IQR) and mean ± standard deviation (SD) in days.
Average of 3 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
Zeitfenster: Average of 3 years
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)
Zeitfenster: Average of 3 years
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)
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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%)
Zeitfenster: Average of 3 years
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)
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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)
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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)
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
Distribution of participants with dyslipidemia by category reported as counts and percentages.
Average of 3 years
36. Percentage of Participants with Obesity by Category
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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%
Zeitfenster: Average of 3 years
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%
Zeitfenster: Average of 3 years
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%
Zeitfenster: Average of 3 years
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)
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years through
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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
Zeitfenster: Average of 3 years
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

AstraZeneca

Ermittler

  • Studienleiter: Hardik Vasnawala, MD, AstraZeneca
  • Studienleiter: Isidro Villanueva, MD, AstraZeneca
  • Studienleiter: Ahmed Hadaoui, PharmD, AstraZeneca

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Februar 2018

Primärer Abschluss (Geschätzt)

31. Dezember 2030

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

15. Mai 2018

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Mai 2018

Zuerst gepostet (Tatsächlich)

8. Juni 2018

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. September 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • D1690R00044

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Qualifizierte Forscher können über das Anfrageportal Zugang zu anonymisierten individuellen Patientendaten aus von der AstraZeneca-Unternehmensgruppe gesponserten klinischen Studien anfordern. Alle Anfragen werden gemäß der AZ-Offenlegungsverpflichtung bewertet:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Ja, zeigt an, dass AZ Anfragen für IPD akzeptiert, aber das bedeutet nicht, dass alle Anfragen geteilt werden.

IPD-Sharing-Zeitrahmen

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IPD-Sharing-Zugriffskriterien

Wenn eine Anfrage genehmigt wurde, gewährt AstraZeneca Zugriff auf die deidentifizierten Daten auf Patientenebene in einem genehmigten gesponserten Tool. Eine unterzeichnete Datenfreigabevereinbarung (nicht verhandelbarer Vertrag für Datenzugriffsberechtigte) muss vorhanden sein, bevor auf angeforderte Informationen zugegriffen werden kann. Darüber hinaus müssen alle Benutzer die Geschäftsbedingungen der SAS MSE akzeptieren, um Zugriff zu erhalten. Weitere Einzelheiten finden Sie in den Offenlegungserklärungen unter https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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