此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

iCaReMe 全球注册 (iCaReMe)

2026年9月7日 更新者:AstraZeneca

确定 2 型糖尿病、高血压、心力衰竭和/或慢性肾脏病患者的管理和护理质量的真实世界跨国注册

提供有关 2 型糖尿病、高血压、心力衰竭和/或慢性肾病患者特征、疾病管理、医疗保健利用和结果的真实世界数据

研究概览

详细说明

该登记处旨在为许多国家的临床实践中的 T2DM、高血压、热衰竭和慢性肾病患者提供有关患者管理和护理质量的真实世界数据。 为了弥合这一差距,建立了一项观察性自愿登记,以获取有关患者特征、疾病管理、医疗保健利用以及 2 型糖尿病、高血压、心力衰竭和慢性肾脏病患者结果的真实世界数据。 使用基于云的 eCRF 的跨国观察登记,用于前瞻性和回顾性数据收集,研究人员和科学委员会可以访问。 该登记处将向全世界管理 T2DM、HTN、HF 或 CKD 的所有医生开放。

研究类型

观察性的

注册 (估计的)

35000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Dnipropetrovsk Oblast
      • Dnipro、Dnipropetrovsk Oblast、乌克兰、49005
        • 招聘中
        • Research Site
    • Kharkiv Oblast
      • Kharkiv、Kharkiv Oblast、乌克兰、61039
        • 招聘中
        • Research Site
      • Kharkiv、Kharkiv Oblast、乌克兰
        • 招聘中
        • Research Site
    • Kyiv Oblast
      • Kyiv、Kyiv Oblast、乌克兰、3039
        • 招聘中
        • Research Site
      • Kyiv、Kyiv Oblast、乌克兰、4050
        • 招聘中
        • Research Site
    • Vinnytsia Oblast
      • Vinnytsia、Vinnytsia Oblast、乌克兰、21000
        • 招聘中
        • Research Site
    • Volyn Oblast
      • Lutsk、Volyn Oblast、乌克兰、43024
        • 招聘中
        • Research Site
    • Zakarpattia Oblast
      • Uzhhorod、Zakarpattia Oblast、乌克兰、88000
        • 招聘中
        • Research Site
    • Zaporizhzhia Oblast
      • Zaporizhzhya、Zaporizhzhia Oblast、乌克兰、69035
        • 招聘中
        • Research Site
      • Tbilisi、乔治亚州
        • 招聘中
        • Research Site
      • Sulaymaniyah、伊拉克、46001
        • 招聘中
        • Research Site
      • Kumasi、加纳
        • 招聘中
        • Research Site
      • Florida、南非、1794
        • 招聘中
        • Research Site
      • Parow、南非、7505
        • 招聘中
        • Research Site
      • Umhlanga、南非、4320
        • 招聘中
        • Research Site
      • Umhlanga、南非、4319
        • 招聘中
        • Research Site
      • Ahmedabad、印度
        • 招聘中
        • Research Site
      • Kolkata、印度、700034
        • 招聘中
        • Research Site
      • Mumbai、印度、400006
        • 招聘中
        • Research Site
      • Changhua、台湾、500209
        • 招聘中
        • Research Site
      • Kaohsiung City、台湾、81301
        • 招聘中
        • Research Site
      • Niaosong、台湾、83301
        • 招聘中
        • Research Site
      • Taichung、台湾、40447
        • 招聘中
        • Research Site
      • Taichung、台湾、40705
        • 招聘中
        • Research Site
      • Taichung、台湾
        • 招聘中
        • Research Site
      • Tainan、台湾、704
        • 招聘中
        • Research Site
      • Taipei、台湾
        • 招聘中
        • Research Site
      • Taoyuan City、台湾、33305
        • 招聘中
        • Research Site
      • Aktobe、哈萨克斯坦、30019
        • 招聘中
        • Research Site
      • Almaty、哈萨克斯坦、50000
        • 招聘中
        • Research Site
      • Almaty、哈萨克斯坦、50006
        • 招聘中
        • Research Site
      • Almaty、哈萨克斯坦、50012
        • 招聘中
        • Research Site
      • Almaty、哈萨克斯坦、50054
        • 招聘中
        • Research Site
      • San José、哥斯达黎加
        • 招聘中
        • Research Site
      • Alexandria、埃及
        • 招聘中
        • Research Site
      • Cairo、埃及
        • 招聘中
        • Research Site
      • Giza、埃及
        • 招聘中
        • Research Site
      • Iztapalapa、墨西哥
        • 招聘中
        • Research Site
      • Mexico City、墨西哥、06720
        • 招聘中
        • Research Site
      • Mexico City、墨西哥
        • 招聘中
        • Research Site
      • México、墨西哥、04530
        • 招聘中
        • Research Site
    • Guanajuato
      • León、Guanajuato、墨西哥、37549
        • 招聘中
        • Research Site
      • Enugu、尼日利亚、400001
        • 招聘中
        • Research Site
      • Gwagwalada、尼日利亚、901002
        • 招聘中
        • Research Site
      • Kano、尼日利亚、700233
        • 招聘中
        • Research Site
      • São Paulo、巴西、05403-000
        • 招聘中
        • Research Site
      • São Paulo、巴西、05403-900
        • 招聘中
        • Research Site
    • Ceará
      • Fortaleza、Ceará、巴西、60840-285
        • 招聘中
        • Research Site
    • Espírito Santo (ES)
      • Colatina、Espírito Santo (ES)、巴西、29707-035
        • 招聘中
        • Research Site
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、40730-220
        • 招聘中
        • Research Site
    • Federal District
      • Brasília、Federal District、巴西、70673-623
        • 招聘中
        • Research Site
    • Minas Gerais
      • Poços de Caldas、Minas Gerais、巴西、37706-106
        • 招聘中
        • Research Site
    • Paraná
      • Campina Grande do Sul、Paraná、巴西、83430-000
        • 招聘中
        • Research Site
      • Curitiba、Paraná、巴西、80230-020
        • 招聘中
        • Research Site
    • Piauí (PI)
      • Teresina、Piauí (PI)、巴西、64001-450
        • 招聘中
        • Research Site
    • Rio Grande Do Sul (RS)
      • Santa Cruz do Sul、Rio Grande Do Sul (RS)、巴西、96835-090
        • 招聘中
        • Research Site
    • State of Goias
      • Goiânia、State of Goias、巴西、74453-200
        • 招聘中
        • Research Site
    • State of Santa Catarina
      • Joinville、State of Santa Catarina、巴西、89204-248
        • 招聘中
        • Research Site
    • São Paulo
      • Bragança Paulista、São Paulo、巴西、12916-542
        • 招聘中
        • Research Site
      • São Caetano do Sul、São Paulo、巴西、09521-160
        • 招聘中
        • Research Site
    • Santiago Metropolitan
      • Providencia、Santiago Metropolitan、智利、7500922
        • 招聘中
        • Research Site
      • Abidjan、科特迪瓦
        • 招聘中
        • Research Site
      • Nairobi、肯尼亚、14497
        • 招聘中
        • Research Site
      • Bulacan、菲律宾
        • 尚未招聘
        • Research Site
      • Cebu City、菲律宾
        • 招聘中
        • Research Site
      • Iloilo City、菲律宾
        • 尚未招聘
        • Research Site
      • Laguna、菲律宾
        • 尚未招聘
        • Research Site
      • Mandaluyong、菲律宾
        • 尚未招聘
        • Research Site
      • Manila、菲律宾
        • 尚未招聘
        • Research Site
      • Mindoro、菲律宾
        • 尚未招聘
        • Research Site
      • Pampanga、菲律宾
        • 尚未招聘
        • Research Site
      • Quezon City、菲律宾
        • 尚未招聘
        • Research Site
      • Zamboanga City、菲律宾
        • 尚未招聘
        • Research Site
      • Sharjah city、阿拉伯联合酋长国
        • 招聘中
        • Research Site
      • Wan Chai、香港
        • 招聘中
        • Research Site
      • Kuala Lumpur、马来西亚
        • 招聘中
        • Research Site

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

取样方法

非概率样本

研究人群

患有 2 型糖尿病、高血压、心力衰竭和/或慢性肾病的成年人

描述

纳入标准:

  1. 年满 18 岁
  2. 患有 2 型糖尿病、高血压、心力衰竭和/或慢性肾病
  3. 提供参与注册表的书面知情同意书

排除标准:

  1. 患有危及生命的合并症且预期寿命低于 1 年
  2. 参与需要知情同意的干预试验

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:其他
  • 时间观点:预期

队列和干预

团体/队列
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
1. Age of particpants
大体时间: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
大体时间:At baseline
Distribution of participants by sex (male/female) reported as counts and percentages.
At baseline
3. Percentage of Participants by Ethnicity
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:At Baseline
Distribution of participants by physical activity level category reported as counts and percentages.
At Baseline
8. Percentage of Participants by Smoking Status
大体时间: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
大体时间:At Baseline
Distribution of participants by alcohol consumption category reported as counts and percentages.
At Baseline
10. Body Weight of Participants
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:At Baseline
Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
At Baseline
17. Primary Disease Duration
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:Average of 3 years
Frequency of echocardiography abnormalities reported as counts and percentages
Average of 3 years
42. Electrocardiogram (ECG)
大体时间:Average of 3 years
Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
Average of 3 years
43. Participants Receiving Dietary Modification Counseling
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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%)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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%
大体时间: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%
大体时间: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%
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 研究主任:Hardik Vasnawala, MD、AstraZeneca
  • 研究主任:Isidro Villanueva, MD、AstraZeneca
  • 研究主任:Ahmed Hadaoui, PharmD、AstraZeneca

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年2月17日

初级完成 (估计的)

2030年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2018年5月15日

首先提交符合 QC 标准的

2018年5月29日

首次发布 (实际的)

2018年6月8日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月7日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

合格的研究人员可以通过请求门户请求访问阿斯利康集团公司赞助的临床试验的匿名个人患者数据。 所有请求都将根据 AZ 披露承诺进行评估:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure。 是,表示 AZ 正在接受 IPD 请求,但这并不意味着所有请求都将共享。

IPD 共享时间框架

根据对 EFPIA 制药数据共享原则的承诺,阿斯利康将达到或超过数据可用性。 有关我们时间表的详细信息,请参阅我们在 https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure 上的披露承诺。

IPD 共享访问标准

当请求获得批准后,阿斯利康将在批准的赞助工具中提供对去识别化的个体患者水平数据的访问。 在访问请求的信息之前,必须签署数据共享协议(数据访问者不可协商的合同)。 此外,所有用户都需要接受 SAS MSE 的条款和条件才能获得访问权限。 有关更多详细信息,请查看 https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure 上的披露声明。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅