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NCT04072523 Clinical Trial

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

Type 2 Diabetes Clinical Trial

— HF-Registry  

Official title:
An Observational, Cross Sectional Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04072523
Other study ID # D1843R00300
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 3, 2019
Est. completion date March 1, 2021

Study information
Verified date February 2022
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 621
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
India Research Site Ahemdabad Gujrat
India Research Site Amritsar Punjab
India Research Site Bangalore Karnataka
India Research Site Bangalore Karnataka
India Research Site Chandigarh Punjab
India Research Site Chennai Tamil Nadu
India Research Site Chennai Tamil Nadu
India Research Site Delhi New Delhi
India Research Site Delhi New Delhi
India Research Site Delhi
India Research Site Delhi
India Research Site Hyderabad Telangana
India Research Site Hyderabad Telengana
India Research Site Jalandhar Punjab
India Research Site Kanpur Uttar Pradesh
India Research Site Kanpur Uttar Pradesh
India Research Site Kochi Kerala
India Research Site Kolkata West Bengal
India Research Site Kolkata West Bengal
India Research Site Kolkata West Bengal
India Research Site Kolkata West Bengal
India Research Site Kolkata West Bengal
India Research Site Ludhiana Punjab
India Research Site Mumbai Maharashtra
India Research Site Rajkot Gujrat
India Research Site Rohtak Haryana

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of Left Ventricular dysfunction based on the BNP levels and echocardiography results. 1 day
Secondary Correlation of Left ventricular dysfunction and heart failure With demographics and comorbidities of the patients to assess relation between them. 1 day
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