Skip to main content
OpenTrials
Completed

NCT Number: NCT04072523

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ahemdabad, Gujarat, India

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of Left Ventricular dysfunction

    Time frame: 1 day

    based on the BNP levels and echocardiography results.

Secondary outcomes

  1. Correlation of Left ventricular dysfunction and heart failure

    Time frame: 1 day

    With demographics and comorbidities of the patients to assess relation between them.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: HF-Registry

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 28, 2019
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.