Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India

Completed

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2019/08/020629

Lead Sponsor: AstraZeneca Pharma India Ltd

Brief Summary: This is an Observational, Cross sectional Study to assess thePrevalence of Heart Failure in Type 2 Diabetes Patients in IndiaThis registry would aim at identifying the prevalence of HF in Type 2 diabetic patients. The registry will also determine whether there is any association between heart failure and T2DM.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1000

Inclusion Criteria

1.Both men and women aged â‰¥ 18 years 2.Diagnosed with type 2 diabetes (as per ADA Criteria [Annexure 1]) 3.Duration of diabetes for 1 year or more 4.Willing to provide written informed consent.

Exclusion Criteria

1.Patients with evidence of coronary artery disease â€“ CAD (based on the clinical expertise of the physician) 2.Patients who were previously diagnosed with heart failure 3.
Patients with evidence of valvular disease based on clinical judgement of the Principle Investigator (PI).
4.Current treatment with digoxin 5.History or symptoms of peripheral artery disease, chronic obstructive pulmonary disease and arrhythmias 6.Patients diagnosed with stage III/IV Chronic Kidney Disease (CKD) 7.Diabetes other than type 2 diabetes mellitus.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the prevalence of LV dysfunction and HF in type 2 DM patients based on the BNP levels and echocardiography results.	10 Months

Secondary Outcome Measures

Name	Time	Method
Correlation of LV dysfunction and heart failure with demographics and comorbidities of the patients to assess relation between them.	10 Months

Trial Locations

Locations (22): Apex Hospital
🇮🇳
Jalandhar, PUNJAB, India
Apollo Gleneagles Hospital
🇮🇳
Kolkata, WEST BENGAL, India
Bangalore Diabetic centre
🇮🇳
Bangalore, KARNATAKA, India
Dr Rohit Kapoorâ€™s Heart Station & Diabetes Clinic
🇮🇳
Amritsar, PUNJAB, India
Dr. Kamal Sharma Cardiology Clinic
🇮🇳
Ahmadabad, GUJARAT, India
F S Endocrine & Diabetic Center
🇮🇳
Hyderabad, TELANGANA, India
Fortis Med Centre
🇮🇳
Chandigarh, CHANDIGARH, India
Heart Clinic
🇮🇳
Delhi, DELHI, India
Holy Heart Advance care & Research Center
🇮🇳
Rohtak, HARYANA, India
ILS Hospital
🇮🇳
Kolkata, WEST BENGAL, India
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Apex Hospital
🇮🇳Jalandhar, PUNJAB, India
Dr Akshata Desai
Principal investigator
9592965544
akshatadesai1@gmail.com