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Recruiting NCT03549754

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

Observational Type 2 Diabetes Hypertension Chronic Kidney Disease Heart Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Hypertension, Chronic Kidney Disease, Heart Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil, Chile, Costa Rica, Côte d’Ivoire, Egypt +15
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Real-world Multinational Registry to Determine Management and Quality of Care of Patients With Type 2 Diabetes, Hypertension, Heart Failure and/or Chronic Kidney Diseases

Overview

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

Detailed description

The registry intends to provide real world data on patient management and quality of care for patients with T2DM, hypertension, heat failure and chronic kidney disease in clinical practice in many countries. To bridge this gap an observational voluntary registry is set up to capture real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart Failure and Chronic Kidney Disease. Multinational, observational registry utilizing a cloud-based eCRF, for prospective and retrospective data collection, accessible to investigators and Scientific Committee. This registry will be open to all physicians managing T2DM, HTN, HF or CKD across the world

Primary outcome measures

  • 1. Age of particpants [Time frame: At Baseline]
  • 2. Percentage of Participants by Sex [Time frame: At baseline]
  • 3. Percentage of Participants by Ethnicity [Time frame: At Baseline]
  • 4. Percentage of Participants by Education Level [Time frame: At Baseline]
  • 5. Percentage of Participants by Marital Status [Time frame: At Baseline]
  • 6. Percentage of Participants with Family History of Cardiovascular and Renal-Metabolic Disease [Time frame: At Baseline]
  • 7.Percentage of Participants by Physical Activity Level [Time frame: At Baseline]
  • 8. Percentage of Participants by Smoking Status [Time frame: At Baseline]
  • 9. Percentage of Participants by Alcohol Consumption [Time frame: At Baseline]
  • 10. Body Weight of Participants [Time frame: At Baseline]
Secondary outcome measures (12)
  • 1. Incidence of Level 1 Hypoglycemic Events (Blood Glucose <70 mg/dL) [Time frame: Average of 3 years]
  • 2.Incidence of Level 2 Hypoglycemic Events (Blood Glucose <54 mg/dL) [Time frame: Average of 3 years]
  • 3.Incidence of Level 3 Hypoglycemic Events (Requiring Third-Party Assistance) [Time frame: Average of 3 years]
  • 4.Incidence of Diabetic Ketoacidosis (DKA) Episodes [Time frame: Average of 3 years]
  • 5. Percentage of Participants with Uncontrolled Type 2 Diabetes (HbA1c ≥7%) [Time frame: Average of 3 years]
  • 6. Percentage of Participants with Uncontrolled Hypertension (BP ≥140/90 mmHg) [Time frame: Average of 3 years]
  • 7. Incidence of Retinopathy [Time frame: Average of 3 years]
  • 8. Incidence of Nephropathy [Time frame: Average of 3 years]
  • 9. Incidence of Neuropathy [Time frame: Average of 3 years]
  • 10. Incidence of Myocardial Infarction (MI) [Time frame: Average of 3 years]
  • 11. Incidence of Stroke [Time frame: Average of 3 years]
  • 12. Incidence of Peripheral Arterial Disease (PAD) [Time frame: Average of 3 years]

Eligibility criteria

Inclusion criteria

  • Being 18 years or older
  • Having type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease
  • Providing written informed consent to participate in the registry

Exclusion criteria

  • Having a life-threatening co-morbidity with life expectancy below 1 year
  • Participating in an interventional trial requiring informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Brazil · 15 centers
  • Research Site — Fortaleza
  • Research Site — Colatina
  • Research Site — Salvador
  • Research Site — Brasília
  • Research Site — Poços de Caldas
  • Research Site — Campina Grande do Sul
  • Research Site — Curitiba
  • Research Site — Teresina
  • … and 7 more centers
Philippines · 10 centers
  • Research Site — Bulacan
  • Research Site — Cebu City
  • Research Site — Iloilo City
  • Research Site — Laguna
  • Research Site — Mandaluyong
  • Research Site — Manila
  • Research Site — Mindoro
  • Research Site — Pampanga
  • … and 2 more centers
Taiwan · 9 centers
  • Research Site — Changhua
  • Research Site — Kaohsiung City
  • Research Site — Niaosong
  • Research Site — Taichung
  • Research Site — Taichung
  • Research Site — Taichung
  • Research Site — Tainan
  • Research Site — Taipei
  • … and 1 more center
Ukraine · 9 centers
  • Research Site — Dnipro
  • Research Site — Kharkiv
  • Research Site — Kharkiv
  • Research Site — Kyiv
  • Research Site — Kyiv
  • Research Site — Vinnytsia
  • Research Site — Lutsk
  • Research Site — Uzhhorod
  • … and 1 more center
Kazakhstan · 5 centers
  • Research Site — Aktobe
  • Research Site — Almaty
  • Research Site — Almaty
  • Research Site — Almaty
  • Research Site — Almaty
Mexico · 5 centers
  • Research Site — León
  • Research Site — Iztapalapa
  • Research Site — Mexico City
  • Research Site — Mexico City
  • Research Site — México
South Africa · 4 centers
  • Research Site — Florida
  • Research Site — Parow
  • Research Site — Umhlanga
  • Research Site — Umhlanga
Egypt · 3 centers
  • Research Site — Alexandria
  • Research Site — Cairo
  • Research Site — Giza
India · 3 centers
  • Research Site — Ahmedabad
  • Research Site — Kolkata
  • Research Site — Mumbai
Nigeria · 3 centers
  • Research Site — Enugu
  • Research Site — Gwagwalada
  • Research Site — Kano
Chile · 1 center
  • Research Site — Providencia
Costa Rica · 1 center
  • Research Site — San José
Côte d’Ivoire · 1 center
  • Research Site — Abidjan
Georgia · 1 center
  • Research Site — Tbilisi
Ghana · 1 center
  • Research Site — Kumasi
Hong Kong · 1 center
  • Research Site — Wan Chai
Iraq · 1 center
  • Research Site — Sulaymaniyah
Kenya · 1 center
  • Research Site — Nairobi
Malaysia · 1 center
  • Research Site — Kuala Lumpur
United Arab Emirates · 1 center
  • Research Site — Sharjah city

Identifiers

NCT: NCT03549754 · D1690R00044

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗