Dear Dr.{{$doctorName}} ,


Subject: Participation in the study entitled: Assessment of drug utilization pattern of Sacubitril/Valsartan in Indian heart failure patients (SECURE)


Heart failure, a complex clinical syndrome often arising from impairment of ventricular filling or ejection of blood, is estimated to affect 26 million people worldwide. It is disabling and deadly, with an annual hospitalization of approximately one million US adults and a 1-year mortality of 23.6% in patients hospitalized with acute HF in high- income settings. Heart failure prevalence varies across regions of the world. However, population-based data on HF prevalence and incidence from India are scarce. Data from the Trivandrum Heart Failure Registry, the International Congestive Heart Failure registry, and Medanta registry provide crucial information on patient characteristics, prevailing treatment practices, and survival of HF in India. However, all of these registries are limited in their geographical representations of India.


Heart failure is the commonest cardiac cause for hospitalization with 1% of the general population being affected annually, which adds up to between 8–10 million patients. The 1% average in the general population looks different when only the 65-79 age group is considered where heart failure related hospitalization is 5-10%. In elderly above 80 years of age such hospitalization is even higher at 10-20%. 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%. Patients with HF in the Trivandrum HF registry were younger, and had a higher prevalence of CAD.


Prevalence of heart failure is increasing because of ageing of the population and improved treatment of acute cardiovascular events, despite the efficacy of many therapies for patients with heart failure with reduced ejection fraction, such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), β blockers, and mineralocorticoid receptor antagonists, and advanced device therapies. Combined angiotensin receptor blocker neprilysin inhibitors (ARNIs) have been associated with improvements in hospital admissions and mortality from heart failure compared with enalapril, and guidelines now recommend substitution of ACE inhibitors or ARBs with ARNIs in appropriate patients.


ESC 2021 has given class I recommendation for ARNI in patients diagnosed with HFrEF and as a replacement for ACEi in patients who remain symptomatic on ACEi/betablockers/MRA. 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 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 heart failure (HF) 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.

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.






With regards,


Sun Pharmaceutical Industries Limited
Sun House, 201/B1, Western Express Highway,
Goregaon (East), Mumbai,
Maharashtra (India) – 400 063