このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

iCaReMe グローバル レジストリ (iCaReMe)

2026年9月7日 更新者:AstraZeneca

2型糖尿病、高血圧、心不全および/または慢性腎臓病患者の管理とケアの質を決定するための現実世界の多国籍レジストリ

2 型糖尿病、高血圧、心不全、および/または慢性腎臓病患者の患者特性、疾患管理、医療利用、転帰に関する実世界のデータを提供する

調査の概要

詳細な説明

レジストリは、多くの国の臨床診療における 2 型糖尿病、高血圧、熱中症、および慢性腎臓病患者の患者管理とケアの質に関する実際のデータを提供することを目的としています。 このギャップを埋めるために、2 型糖尿病、高血圧、心不全、および慢性腎臓病患者の患者特性、疾患管理、医療利用、転帰に関する実際のデータを取得するために、任意の観察レジストリが設定されています。 クラウドベースの eCRF を利用した多国籍の観察レジストリで、研究者や科学委員会がアクセスできる前向きおよび遡及的なデータ収集が可能です。 このレジストリは、世界中の 2 型糖尿病、HTN、HF、または CKD を管理しているすべての医師に公開されます。

研究の種類

観察的

入学 (推定)

35000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

      • Sharjah city、アラブ首長国連邦
        • 募集
        • Research Site
      • Sulaymaniyah、イラク、46001
        • 募集
        • Research Site
      • Ahmedabad、インド
        • 募集
        • Research Site
      • Kolkata、インド、700034
        • 募集
        • Research Site
      • Mumbai、インド、400006
        • 募集
        • Research Site
    • Dnipropetrovsk Oblast
      • Dnipro、Dnipropetrovsk Oblast、ウクライナ、49005
        • 募集
        • Research Site
    • Kharkiv Oblast
      • Kharkiv、Kharkiv Oblast、ウクライナ、61039
        • 募集
        • Research Site
      • Kharkiv、Kharkiv Oblast、ウクライナ
        • 募集
        • Research Site
    • Kyiv Oblast
      • Kyiv、Kyiv Oblast、ウクライナ、3039
        • 募集
        • Research Site
      • Kyiv、Kyiv Oblast、ウクライナ、4050
        • 募集
        • Research Site
    • Vinnytsia Oblast
      • Vinnytsia、Vinnytsia Oblast、ウクライナ、21000
        • 募集
        • Research Site
    • Volyn Oblast
      • Lutsk、Volyn Oblast、ウクライナ、43024
        • 募集
        • Research Site
    • Zakarpattia Oblast
      • Uzhhorod、Zakarpattia Oblast、ウクライナ、88000
        • 募集
        • Research Site
    • Zaporizhzhia Oblast
      • Zaporizhzhya、Zaporizhzhia Oblast、ウクライナ、69035
        • 募集
        • Research Site
      • Alexandria、エジプト
        • 募集
        • Research Site
      • Cairo、エジプト
        • 募集
        • Research Site
      • Giza、エジプト
        • 募集
        • Research Site
      • Aktobe、カザフスタン、30019
        • 募集
        • Research Site
      • Almaty、カザフスタン、50000
        • 募集
        • Research Site
      • Almaty、カザフスタン、50006
        • 募集
        • Research Site
      • Almaty、カザフスタン、50012
        • 募集
        • Research Site
      • Almaty、カザフスタン、50054
        • 募集
        • Research Site
      • Kumasi、ガーナ
        • 募集
        • Research Site
      • Tbilisi、グルジア
        • 募集
        • Research Site
      • Nairobi、ケニア、14497
        • 募集
        • Research Site
      • San José、コスタリカ
        • 募集
        • Research Site
      • Abidjan、コートジボワール
        • 募集
        • Research Site
    • Santiago Metropolitan
      • Providencia、Santiago Metropolitan、チリ、7500922
        • 募集
        • Research Site
      • Enugu、ナイジェリア、400001
        • 募集
        • Research Site
      • Gwagwalada、ナイジェリア、901002
        • 募集
        • Research Site
      • Kano、ナイジェリア、700233
        • 募集
        • Research Site
      • Bulacan、フィリピン
        • まだ募集していません
        • Research Site
      • Cebu City、フィリピン
        • 募集
        • Research Site
      • Iloilo City、フィリピン
        • まだ募集していません
        • Research Site
      • Laguna、フィリピン
        • まだ募集していません
        • Research Site
      • Mandaluyong、フィリピン
        • まだ募集していません
        • Research Site
      • Manila、フィリピン
        • まだ募集していません
        • Research Site
      • Mindoro、フィリピン
        • まだ募集していません
        • Research Site
      • Pampanga、フィリピン
        • まだ募集していません
        • Research Site
      • Quezon City、フィリピン
        • まだ募集していません
        • Research Site
      • Zamboanga City、フィリピン
        • まだ募集していません
        • Research Site
      • São Paulo、ブラジル、05403-000
        • 募集
        • Research Site
      • São Paulo、ブラジル、05403-900
        • 募集
        • Research Site
    • Ceará
      • Fortaleza、Ceará、ブラジル、60840-285
        • 募集
        • Research Site
    • Espírito Santo (ES)
      • Colatina、Espírito Santo (ES)、ブラジル、29707-035
        • 募集
        • Research Site
    • Estado de Bahia
      • Salvador、Estado de Bahia、ブラジル、40730-220
        • 募集
        • Research Site
    • Federal District
      • Brasília、Federal District、ブラジル、70673-623
        • 募集
        • Research Site
    • Minas Gerais
      • Poços de Caldas、Minas Gerais、ブラジル、37706-106
        • 募集
        • Research Site
    • Paraná
      • Campina Grande do Sul、Paraná、ブラジル、83430-000
        • 募集
        • Research Site
      • Curitiba、Paraná、ブラジル、80230-020
        • 募集
        • Research Site
    • Piauí (PI)
      • Teresina、Piauí (PI)、ブラジル、64001-450
        • 募集
        • Research Site
    • Rio Grande Do Sul (RS)
      • Santa Cruz do Sul、Rio Grande Do Sul (RS)、ブラジル、96835-090
        • 募集
        • Research Site
    • State of Goias
      • Goiânia、State of Goias、ブラジル、74453-200
        • 募集
        • Research Site
    • State of Santa Catarina
      • Joinville、State of Santa Catarina、ブラジル、89204-248
        • 募集
        • Research Site
    • São Paulo
      • Bragança Paulista、São Paulo、ブラジル、12916-542
        • 募集
        • Research Site
      • São Caetano do Sul、São Paulo、ブラジル、09521-160
        • 募集
        • Research Site
      • Kuala Lumpur、マレーシア
        • 募集
        • Research Site
      • Iztapalapa、メキシコ
        • 募集
        • Research Site
      • Mexico City、メキシコ、06720
        • 募集
        • Research Site
      • Mexico City、メキシコ
        • 募集
        • Research Site
      • México、メキシコ、04530
        • 募集
        • Research Site
    • Guanajuato
      • León、Guanajuato、メキシコ、37549
        • 募集
        • Research Site
      • Florida、南アフリカ、1794
        • 募集
        • Research Site
      • Parow、南アフリカ、7505
        • 募集
        • Research Site
      • Umhlanga、南アフリカ、4320
        • 募集
        • Research Site
      • Umhlanga、南アフリカ、4319
        • 募集
        • Research Site
      • Changhua、台湾、500209
        • 募集
        • Research Site
      • Kaohsiung City、台湾、81301
        • 募集
        • Research Site
      • Niaosong、台湾、83301
        • 募集
        • Research Site
      • Taichung、台湾、40447
        • 募集
        • Research Site
      • Taichung、台湾、40705
        • 募集
        • Research Site
      • Taichung、台湾
        • 募集
        • Research Site
      • Tainan、台湾、704
        • 募集
        • Research Site
      • Taipei、台湾
        • 募集
        • Research Site
      • Taoyuan City、台湾、33305
        • 募集
        • Research Site
      • Wan Chai、香港
        • 募集
        • Research Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

2型糖尿病、高血圧、心不全および/または慢性腎臓病の成人

説明

包含基準:

  1. 18歳以上であること
  2. 2型糖尿病、高血圧、心不全および/または慢性腎臓病を患っている
  3. レジストリに参加するための書面によるインフォームド コンセントの提供

除外基準:

  1. 生命を脅かす併存疾患があり、平均余命が1年未満である
  2. -インフォームドコンセントを必要とする介入試験への参加

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:他の
  • 時間の展望:見込みのある

コホートと介入

グループ/コホート
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

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
1. Age of particpants
時間枠: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
時間枠:At baseline
Distribution of participants by sex (male/female) reported as counts and percentages.
At baseline
3. Percentage of Participants by Ethnicity
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:At Baseline
Distribution of participants by physical activity level category reported as counts and percentages.
At Baseline
8. Percentage of Participants by Smoking Status
時間枠: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
時間枠:At Baseline
Distribution of participants by alcohol consumption category reported as counts and percentages.
At Baseline
10. Body Weight of Participants
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:At Baseline
Distribution of participants by cardiac and renal functional measurement categories reported as counts and percentages.
At Baseline
17. Primary Disease Duration
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Average of 3 years
Frequency of echocardiography abnormalities reported as counts and percentages
Average of 3 years
42. Electrocardiogram (ECG)
時間枠:Average of 3 years
Frequency of electrocardiogram (ECG) abnormalities reported as counts and percentages
Average of 3 years
43. Participants Receiving Dietary Modification Counseling
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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%)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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%
時間枠: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%
時間枠: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%
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Hardik Vasnawala, MD、AstraZeneca
  • スタディディレクター:Isidro Villanueva, MD、AstraZeneca
  • スタディディレクター:Ahmed Hadaoui, PharmD、AstraZeneca

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年2月17日

一次修了 (推定)

2030年12月31日

研究の完了 (推定)

2030年12月31日

試験登録日

最初に提出

2018年5月15日

QC基準を満たした最初の提出物

2018年5月29日

最初の投稿 (実際)

2018年6月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月9日

QC基準を満たした最後の更新が送信されました

2026年9月7日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

資格のある研究者は、リクエスト ポータルを介して、アストラゼネカが臨床試験を後援する企業グループから匿名化された個々の患者レベルのデータへのアクセスをリクエストできます。 すべてのリクエストは、AZ 開示コミットメントに従って評価されます。

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. はい、AZ が IPD の要求を受け入れていることを示しますが、これはすべての要求が共有されるという意味ではありません。

IPD 共有時間枠

アストラゼネカは、EFPIA Pharma Data Sharing Principles へのコミットメントに従って、データの可用性を満たしているか、それを上回っています。 タイムラインの詳細については、https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure の開示に関するコミットメントを参照してください。

IPD 共有アクセス基準

要求が承認されると、アストラゼネカは、承認済みのスポンサー付きツールで匿名化された個々の患者レベルのデータへのアクセスを提供します。 要求された情報にアクセスする前に、署名済みのデータ共有契約 (データ アクセサーのための交渉不可の契約) を締結する必要があります。 さらに、すべてのユーザーがアクセスするには、SAS MSE の利用規約に同意する必要があります。 詳細については、https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure で開示声明を確認してください。

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する