Status:
COMPLETED
An Observational Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients
Lead Sponsor:
AstraZeneca
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
Brief Summary
An Observational Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India.
Detailed Description
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 T...
Eligibility Criteria
Inclusion
- Both men and women aged ≥ 18 years
- Diagnosed with type 2 diabetes (as per ADA Criteria)
- Duration of diabetes for 1 year or more
- Willing to provide the informed consent
Exclusion
- Patients with evidence of coronary artery disease - CAD (based on the clinical expertise of the physician).
- Patients who were previously diagnosed with heart failure.
- Patients with evidence of valvular disease based on clinical judgement of the Principle Investigator (PI).
- Current treatment with digoxin.
- History of symptoms of peripheral artery disease, chronic obstructive pulmonary disease and arrhythmias.
- Patients diagnosed with stage III/IV CKD
- Diabetes other than type 2 diabetes mellitus.
Key Trial Info
Start Date :
December 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT04072523
Start Date
December 3 2019
End Date
March 1 2021
Last Update
March 4 2022
Active Locations (26)
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1
Research Site
Ahemdabad, Gujarat, India, 380013
2
Research Site
Rajkot, Gujarat, India, 360001
3
Research Site
Rohtak, Haryana, India, 124001
4
Research Site
Bangalore, Karnataka, India, 560043