Subject: Evaluate Prevalence of Heart Failure and Current Management Practices and Risk Factors in Indian Patients. (PRO-MERIT)
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 the 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.
Recently published data shows a high prevalence of diabetes and hypertension in India (7.5% & 25.3%) respectively. Dyslipidemia is on the rise (79%) as evident from the ICMR- INDIAB study. Coronary Heart Disease (CHD) prevalence in India has increased and estimated to be around 30 million. Hence, heart failure would be a major reason for morbidity and mortality. Thus, this increased burden at a young age leads to loss of productivity and is a barrier for economic growth.
This retrospective, cross-sectional multicenter study is planned to evaluate the prevalence of types of heart failure, etiological cause, risk factors associated and current management practices of 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 12 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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