An Observational Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients (HF-Registry)

AstraZeneca

Status: Completed

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Industry

Identifiers

NCT04072523

D1843R00300

Details and patient eligibility

About

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

Full 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).

Enrollment: 621 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

621 participants in 1 patient group

Observational Study Investigational Product NA

Description:

Patients : Type 2 Diabetic Patients