Study of the Clinical Characteristics and Management of Indian Outpatients of Chronic Heart Failure with Coexistent Diabetes Versus those without Diabetes (HF-DIAB): Rationale and Design

Introduction: Heart failure (HF) is a significant and rising health burden in India. Diabetes mellitus is commonly prevalent in HF patients. However, data comparing the clinical characteristics and management of Indian HF patients with and without coexistent diabetes is lacking. Also, differences in HF management patterns between cardiologists and internists have not been systematically ascertained in India. This study is designed to address these gaps in knowledge. Methods and analysis: HF-DIAB is a prospective multicenter study that aims to obtain data on 2,500 Indian adult outpatients with chronic HF recruited from 250 outpatient clinics across India; half of the included subjects will have a history of coexistent diabetes. Data on the patient’s demographics, personal and medical history, signs and symptoms of HF, etiology and clinical presentation of HF, diagnostic tests performed, previous HF-related hospitalizations, drugs prescribed for HF/diabetes and other comorbidities will be collected. Independent sample t-test will be used to compare differences between diabetic and non-diabetic HF subjects for various clinical characteristics measured using clinical variables. Chi- square test will be used to find out the association between diabetics and non-diabetics with various risk factors and clinical characteristics measured using categorical data. Differences in HF treatment, as per the specialty of the treating doctor, will also be compared using Chi-square test. Ethics and dissemination: The study documents have been reviewed and approved by an independent ethics committee. Data-sharing consent will be obtained from each patient before enrollment in the study. The study results will be disseminated through publications in peer-reviewed journals. Trial registration number: Clinical Trials Registry: India [CTRI/2017/07/009069].