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

NCT ID: NCT04072523

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-03

Study Completion Date

2021-03-01

Brief Summary

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

Detailed Description

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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).

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Observational Study Investigational Product NA

Patients : Type 2 Diabetic Patients

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Ahemdabad, Gujarat, India

Site Status

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Rajkot, Gujarat, India

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Rohtak, Haryana, India

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Bangalore, Karnataka, India

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Bangalore, Karnataka, India

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Kochi, Kerala, India

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Mumbai, Maharashtra, India

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Delhi, New Delhi, India

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Delhi, New Delhi, India

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Amritsar, Punjab, India

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Chandigarh, Punjab, India

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Jalandhar, Punjab, India

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Ludhiana, Punjab, India

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Chennai, Tamil Nadu, India

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Chennai, Tamil Nadu, India

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Hyderabad, Telangana, India

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Hyderabad, Telangana, India

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Kanpur, Uttar Pradesh, India

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Kanpur, Uttar Pradesh, India

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Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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Kolkata, West Bengal, India

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Delhi, , India

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Delhi, , India

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Countries

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India

Other Identifiers

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D1843R00300

Identifier Type: -

Identifier Source: org_study_id

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