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

February 17, 2022 updated by: AstraZeneca

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

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

621

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India, 110085
        • Research Site
      • Delhi, India, 110026
        • Research Site
    • Gujrat
      • Ahemdabad, Gujrat, India, 380013
        • Research Site
      • Rajkot, Gujrat, India, 360001
        • Research Site
    • Haryana
      • Rohtak, Haryana, India, 124001
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India, 560043
        • Research Site
      • Bangalore, Karnataka, India, 560094
        • Research Site
    • Kerala
      • Kochi, Kerala, India, 682020
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400081
        • Research Site
    • New Delhi
      • Delhi, New Delhi, India, 110007
        • Research Site
      • Delhi, New Delhi, India, 110085
        • Research Site
    • Punjab
      • Amritsar, Punjab, India, 143001
        • Research Site
      • Chandigarh, Punjab, India, 160011
        • Research Site
      • Jalandhar, Punjab, India, 144001
        • Research Site
      • Ludhiana, Punjab, India, 141001
        • Research Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600024
        • Research Site
      • Chennai, Tamil Nadu, India, 600040
        • Research Site
    • Telangana
      • Hyderabad, Telangana, India, 500059
        • Research Site
    • Telengana
      • Hyderabad, Telengana, India, 500047
        • Research Site
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208001
        • Research Site
      • Kanpur, Uttar Pradesh, India, 208002
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Research Site
      • Kolkata, West Bengal, India, 700019
        • Research Site
      • Kolkata, West Bengal, India, 700029
        • Research Site
      • Kolkata, West Bengal, India, 700050
        • Research Site
      • Kolkata, West Bengal, India, 700064
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

type 2 diabetes mellitus patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Observational Study Investigational Product NA
Patients : Type 2 Diabetic Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Left Ventricular dysfunction
Time Frame: 1 day
based on the BNP levels and echocardiography results.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Left ventricular dysfunction and heart failure
Time Frame: 1 day
With demographics and comorbidities of the patients to assess relation between them.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2019

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

August 27, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1843R00300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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