An Observational Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT04072523
• Lead Sponsor: AstraZeneca

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).

Study Timeline

• Study First Submitted: 2019-08-27
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Study Start: 2019-12-03
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 621

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Left Ventricular dysfunction	1 day	based on the BNP levels and echocardiography results.

Secondary Outcome Measures

Name	Time	Method
Correlation of Left ventricular dysfunction and heart failure	1 day	With demographics and comorbidities of the patients to assess relation between them.

Trial Locations

Locations (1)

Research Site; 🇮🇳 Delhi, India