An Observational, Cross Sectional Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 621
- Locations
- 1
- Primary Endpoint
- Prevalence of Left Ventricular dysfunction
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Prevalence of Left Ventricular dysfunction
Time Frame: 1 day
based on the BNP levels and echocardiography results.
Secondary Outcomes
- Correlation of Left ventricular dysfunction and heart failure(1 day)