Subject: Assessment of drug utilization pattern of Sacubitril/Valsartan in combination with other heart failure therapies in Indian heart failure patients (SECURE II)
The prevalence of heart failure (HF) in India is around 1% of the total population, whereas globally, it is around 1–2%, increasing to ≥ 10% among patients aged > 70 years. As per the data published in the Trivandrum Heart Failure Registry (THFR), HF with preserved ejection fraction represents 25% of the total HF burden, which indicates that HF with reduced ejection fraction (HFrEF) is more predominant. Among Indian patients, adherence to medication ranges from 25% to 50%, and compliance to guideline-directed medical therapy (GDMT) is low. In Indian patients, the prognosis of HF is very poor. As per the THFR data, the in-hospital mortality rate reported was 8.4% as compared to 4% in the ADHERE of USA. Factors leading to higher readmission rates and mortality in India as per literature are lack of GDMT, poor education, lack of adherence to guidelines, poor treatment compliance, older age, New York Heart Association (NYHA) functional class IV status, and increased serum creatinine. ACC/AHA/HFSA 2022 has given class I recommendation for ARNI in patients diagnosed with HFrEF, they recommend ARNI as first-line and to use ACEi or ARB when it is not feasible to use ARNI. Although heart failure prevalence is growing in India, there is a lack of evidence on heart failure management practices at present, there is lack of country wide data to obtain meaningful insights on the drug utilization pattern of sacubitril/valsartan in combination with other heart failure therapies in patients with heart failure stated in these guidelines.
This retrospective, cross-sectional multicenter study is planned to evaluate the drug utilization pattern of sacubitril/valsartan in combination with other heart failure therapies in heart failure (HF) patients of 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.
In alignment with good clinical research practices, an independent 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.
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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