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An Observational Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India.
This is a cross sectional, observational, multi-centre study to be conducted at 40 centres in India. The study targets to enrol 1000 patients with approx. 25 patients per site. The study would enrol Type 2 Diabetes Mellitus patients who provide written informed consent. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators' routine clinical practice will be screened for enrolment in study. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Study Investigational Product NA | Patients : Type 2 Diabetic Patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Left Ventricular dysfunction | based on the BNP levels and echocardiography results. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of Left ventricular dysfunction and heart failure | With demographics and comorbidities of the patients to assess relation between them. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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type 2 diabetes mellitus patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ahemdabad | Gujarat | 380013 | India | ||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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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.
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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.
When a request has been approved AstraZeneca will provide access to the de-identified 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.
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| Rajkot |
| Gujarat |
| 360001 |
| India |
| Research Site | Rohtak | Haryana | 124001 | India |
| Research Site | Bangalore | Karnataka | 560043 | India |
| Research Site | Bangalore | Karnataka | 560094 | India |
| Research Site | Kochi | Kerala | 682020 | India |
| Research Site | Mumbai | Maharashtra | 400081 | India |
| Research Site | Delhi | New Delhi | 110007 | India |
| Research Site | Delhi | New Delhi | 110085 | India |
| Research Site | Amritsar | Punjab | 143001 | India |
| Research Site | Chandigarh | Punjab | 160011 | India |
| Research Site | Jalandhar | Punjab | 144001 | India |
| Research Site | Ludhiana | Punjab | 141001 | India |
| Research Site | Chennai | Tamil Nadu | 600024 | India |
| Research Site | Chennai | Tamil Nadu | 600040 | India |
| Research Site | Hyderabad | Telangana | 500047 | India |
| Research Site | Hyderabad | Telangana | 500059 | India |
| Research Site | Kanpur | Uttar Pradesh | 208001 | India |
| Research Site | Kanpur | Uttar Pradesh | 208002 | India |
| Research Site | Kolkata | West Bengal | 700019 | India |
| Research Site | Kolkata | West Bengal | 700029 | India |
| Research Site | Kolkata | West Bengal | 700050 | India |
| Research Site | Kolkata | West Bengal | 700054 | India |
| Research Site | Kolkata | West Bengal | 700064 | India |
| Research Site | Delhi | 110026 | India |
| Research Site | Delhi | 110085 | India |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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