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iCaReMe Global Registry (iCaReMe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549754
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : January 11, 2023
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

Condition or disease
Type 2 Diabetes Hypertension Chronic Kidney Disease Heart Failure

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 35000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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
Actual Study Start Date : February 17, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 1. Provide real world data on patient characteristics [ Time Frame: Average of 3 years through study completion ]
    Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes, CKD and HF treatments Concomitant medications

  2. 2. Provide real world data on disease management [ Time Frame: Average of 3 years through study completion ]
    Disease control (e.g. achievement of glycated hemoglobin target and incidence of hypoglycemic events) Management of micro- and/or macrovascular complications Management of associated risk factors (e.g. hypercholesterolemia and hypertension) Current diabetes treatments Concomitant medications

  3. 3. Provide real world data on healthcare utilization [ Time Frame: Average of 3 years through study completion ]
    Number of diabetes, Chronic Kidney Disease(CKD) and Heart Failure(HF)-related visits to a physician not at study site Number of urgent care visits for diabetes Number of diabetes, CKD and HF-related hospital emergency department visits and reason(s) for visits Number of hospitalizations, lengths of stay, and reasons for hospitalizations

  4. 4. Provide real world data on quality of care indicators [ Time Frame: Average of 3 years through study completion ]
    Smoking cessation Eye and foot examinations Dietary counselling

  5. Provide real world data on cardiovascular outcomes in patients with type 2 diabetes; Chronic Kidney Disease and Heart Failure [ Time Frame: Average of 3 years through study completion ]
    All-cause and cause-specific deaths and hospitalizations, including recurrent events

  6. 6. Provide real world data on renal outcomes and other microvascular complications in patients with type 2 diabetes and Heart Failure [ Time Frame: Average of 3 years through study completion ]
    All-cause and cause-specific deaths and hospitalizations, including recurrent events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with type 2 diabetes, Hypertension, Heart Failure and/or chronic kidney disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Having a life-threatening co-morbidity with life expectancy below 1 year
  2. Participating in an interventional trial requiring informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549754


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Costa Rica
Research Site Recruiting
San Jose, Los Yoses, San Pedro, Costa Rica, 11501
Egypt
Research Site Not yet recruiting
Fleming, Alexandria, Egypt
Research Site Not yet recruiting
Downtown, Assiut, Egypt
Research Site Not yet recruiting
Haram, Cairo, Egypt
India
Research Site Recruiting
Ahmedabad, Gujarat, India, 380015
Research Site Recruiting
Rohtak, Haryana, India, 124514
Research Site Not yet recruiting
Bangalore, Karnataka, India, 560010
Research Site Recruiting
Pune, Maharashtra, India, 411001
Research Site Recruiting
Chennai, Royapuram, India, 600013
Research Site Recruiting
Kolkata, West Bengal, India, 700098
Research Site Not yet recruiting
Kolkata, West Bengal, India, 700098
Research Site Recruiting
Delhi, India, 110063
Research Site Not yet recruiting
Pondicherry, India, 605014
Research Site Not yet recruiting
Vadodara, India, 390023
Malaysia
Research Site Recruiting
Johor Darul Takzim, Iskandar Puteri, Malaysia, 79250
Mexico
Research Site Completed
Guadalajara, Jalisco, Mexico, 44340
Research Site Completed
Guadalajara, Jalisco, Mexico, 44600
Research Site Completed
Guadalajara, Jalisco, Mexico, 44670
Research Site Completed
Monterrey, Nuevo Leon, Mexico, 64460
Research Site Completed
San Juan del Rio, Queretaro, Mexico, 76800
Research Site Completed
Chihuahua, Mexico, 31217
Sponsors and Collaborators
AstraZeneca
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03549754    
Other Study ID Numbers: D1690R00044
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Registry
Type 2 Diabetes
T2DM
Chronic Kidney Disease
CKD
Hypertension
 HTN
Adult population
Heart Failure
HF
Early cardiorenal complications
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Heart Failure
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Urologic Diseases
Renal Insufficiency