Subject: Assessment of heart failure management practices in Indian diabetic patients with preserved ejection fraction on SGLT2 inhibitors (INDO-HF 2 Study)
In India Heart Failure affects 8-10 million individuals and is associated with a mortality of 0.1-0.16 million individuals per year. According to Trivandrum registry, the prevalence of Heart Failure with preserved ejection fraction was 894 (74%), and prevalence of HF preserved ejection fraction are 311 (26%). Heart failure (HF) is a chronic progressive syndrome with multiple aetiologies, advances in terms of treatment, prevention, and rehabilitation have improved the prognosis for HF and the patients' quality of life. In large cohort study it was found that prevalence rates increased with age, from 0.2 per 1000 in people aged under 35 years of age to 125 per 1000 in those aged 85 years and over. Coronary heart disease (present in 47%) was the most common comorbid condition in men with heart failure, whereas hypertension (present in 46%) was the most common condition in women. In 2020, the members of the Heart Failure Society of America (HFSA), the Heart Failure Association of the European Society of Cardiology (HFA/ESC), and the Japanese Heart Failure Society (JHFS) consensually defined HF as "a clinical syndrome with symptoms and/or signs caused by a structural and/or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion". Based on the calculated left ventricular ejection fraction (EF), HF is classified as (1) HF with reduced EF (HFrEF; EF ≤40%), (2) HF with preserved EF (HFpEF; EF ≥50%), (3) HF with mid-range EF (HFmrEF; EF 41-49%), and (4) HF with improved EF (HFimpEF; baseline EF <40% and a second EF>40%) The Trivandrum HF registry (THFR) enrolled 1205 admissions for HF (834 men, 69%). The mean age was 61.2 years. The most common etiology of HF was ischemic heart disease (72%). HF with preserved ejection fraction (HFpEF) constituted 26%. A study by Harikrishnan S has shown Heart failure with preserved ejection fraction (HFPEF) accounts for 15-20% of patients with heart failure (HF) in India. Diagnosis is by clinical features supported by biomarkers and echocardiography. Lifestyle modifications, control of risk factors to optimum levels, and treatment of comorbidities are essential in the management of HFpEF. For effective diagnosis of the disease and management of patients with HF or particularly HFPEF, several guidelines, such as ESC and American Heart Association (AHA)/American College of Cardiology (ACC), have recommended various diagnostic tools to determine prognosis or disease severity and evidence-based approach, respectively. Several pharmacological and non-pharmacological treatment options are available to manage heart failure which improve symptoms, quality of life, and prognosis. The most important pharmacological treatments include renin-angiotensin-aldosterone system (RAAS) inhibitors, beta-blockers, diuretics, ARNI, and SGLT2i. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have recently been shown to reduce the composite of heart failure hospitalization or cardiovascular death in patients with HFPEF in the landmark DELIVER and EMPEROR-Preserved trials. While improvements in blood sugar, blood pressure, and attenuation of kidney disease progression all may play some role, preclinical and translational research have identified additional mechanisms of these agents. There are growing evidences displaying cardiorenal benefits for SGLT2i recently with price reduction of SGLT2i therapy due to generic dapagliflozin there has been surge in acceptance of this drug in heart failure and CKD. In India, physicians may prescribe various medications depending on the severity of disease, age, coexisting morbidities, and tolerance to medications. The objective of this study is to assess drug utilization and Heart Failure management practices.
This retrospective, cross-sectional multicenter study is planned to assess drug utilization and Heart Failure management practices in patients in India.
We invite you to participate in this study. On acceptance, you will need to capture the relevant data as mentioned in the standard Data Collection Form (DCF) provided, from the patient's medical records (case papers and investigational reports - hereafter referred as source documents).
We would recommend you to capture data fulfilling the criteria as outlined in the protocol and whose relevant laboratory investigations are available for the preceding 3 months.
We wish to inform you that the DCF will capture all data in de-identified form and any identifiable parameters which may potentially disclose the identity of the patient such as name or address will strictly not be captured so as to ensure we maintain patient confidentiality. We would encourage you to carefully fill all available information to the fullest as recommended in the DCF
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