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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.
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