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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04072523

Acronym

HF-Registry

Enrollment

621

Registered

2019-08-28

Start date

2019-12-03

Completion date

2021-03-01

Last updated

2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes, Heart Failure

Brief summary

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

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Outcome results