Clinical trial NCT04072523: An Observational Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients
Official title: An Observational, Cross Sectional Study to Assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes, Heart Failure
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 621
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 diabetes mellitus patients

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Left Ventricular dysfunction
timeFrame: 1 day
Secondary outcomes:
measure: Correlation of Left ventricular dysfunction and heart failure
timeFrame: 1 day
Other outcomes:
Locations:
city: Ahemdabad
country: India
facility: Research Site
state: Gujrat
city: Rajkot
country: India
facility: Research Site
state: Gujrat
city: Rohtak
country: India
facility: Research Site
state: Haryana
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Kochi
country: India
facility: Research Site
state: Kerala
city: Mumbai
country: India
facility: Research Site
state: Maharashtra
city: Delhi
country: India
facility: Research Site
state: New Delhi
city: Delhi
country: India
facility: Research Site
state: New Delhi
city: Amritsar
country: India
facility: Research Site
state: Punjab
city: Chandigarh
country: India
facility: Research Site
state: Punjab
city: Jalandhar
country: India
facility: Research Site
state: Punjab
city: Ludhiana
country: India
facility: Research Site
state: Punjab
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Chennai
country: India
facility: Research Site
state: Tamil Nadu
city: Hyderabad
country: India
facility: Research Site
state: Telangana
city: Hyderabad
country: India
facility: Research Site
state: Telengana
city: Kanpur
country: India
facility: Research Site
state: Uttar Pradesh
city: Kanpur
country: India
facility: Research Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Kolkata
country: India
facility: Research Site
state: West Bengal
city: Delhi
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
Study officials:
References: