Subject: Assessment of heart failure management practices in Indian diabetic and non-diabetic patients with reduced ejection fraction on SGLT2 inhibitors (INDO-HF Study)
Heart failure (HF) is responsible for 1.8 million hospitalizations annually in India, and it affects 2–3% of the world’s total population. HF is one of the leading medical causes of hospital admission among elderly population. Patients with HF admissions are very young (~ 53 years) in India compared with ~ 70 years in the USA and Europe.
The prevalence of HF in India is possibly on the rise as India remains doubly burdened by the rise in the risk factors of traditional cardiovascular disease (CVD) and by the persistence of pre-transitional diseases such as RHD, endomyocardial fibrosis, tuberculous pericardial disease and anemia.
Heart failure can be managed with a variety of pharmaceutical and non-pharmacological treatments that enhance symptoms, quality of life, and prognosis. Recently AHA 2023 guidelines recommend using SGLT2i in class 1a for treating heart failure with a reduced ejection fraction (HFrEF), class 2a for treating heart failure with a mildly reduced ejection fraction (HFmrEF), and class 3a for treating heart failure with a preserved ejection fraction (HFpEF). Thus, SGLT2i has become one of the pillars for the treatment of heart failure.
Studies have shown that the sequential introduction of all four drugs during the initial hospitalization and rapid up-titration within a month helps to better target all the different pathological pathways activated in HFrEF. Such interventions have demonstrated therapeutic benefit within 30 days, decrease hospital stay, lower death, and lengthen life without events.
The objective of the current study is to assess the management of Heart Failure in India using the most recent AHA recommendations. 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.
In alignment with good clinical research practices, an independent Contract Research Organization (CRO) will monitor this study and do the source data verification of the data captured in the DCF with copies of the patients’ source medical records (case papers and investigational reports) to ensure that the data entered in the DCFs are accurate and in alignment with the patients’ medical records. The study is approved by independent ethics committee.
If you agree to participate in the said study, we would request you to sign and return the enclosed reply along with your visiting card for accuracy of records.
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