Subject: Evaluate PRevalence Of Heart Failure with preserved ejection fraction and current ManagEment pRactIces in Indian paTients. (PRO-MERIT - 2)
Heart failure (HF) is a complex syndrome associated with increased mortality and morbidity . It is characterized by decreased functionality of heart muscles to pump blood, resulting in reduced quality of life. It has affected approximately 38 million people worldwide and the prevalence of h eart failure in India due to coronary heart disease, hypertension, obesity, diabetes and rheumatic heart disease to range from 1.3 to 4.6 million, with an annual incidence of 491 600-1.8 million. In 2020, the members of the Heart Failure Society of America (HFSA), the Heart Failure Association of the European Society of Cardiology (HFA/ESC), and the Japanese Heart Failure Society (JHFS) consensually defined HF as “a clinical syndrome with symptoms and/or signs caused by a structural and/or func tional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion”. Based on the calculated left ventricular ejection fraction (EF), HF is classified as (1) HF with reduced EF (HFrEF; EF ≤40%), (2) HF with preserved EF (HFpEF; EF ≥50%), (3) HF with mid-range EF (HFmrEF; EF 41-49%), and (4) HF with improved EF (HFimpEF; baseline EF ≤40% and a second EF >40%). 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%. A study by Harikrishnan S has shown Heart failure with preserved ejection fraction (HFpEF) accounts for 15-20% of patients with heart failure (HF) in India. Diagnosis is by clinical features supported by biomarkers and echocardiography. Lifestyle modifications, control of risk factors to optimum levels, and treatment of comorbidities are essential in the management of HFpEF. For effective diagnosis of the disease and management of patients with HF or particularly HFpEF, several guidelines, such as ESC and American Heart Association (AHA)/American College of Cardiology (ACC), have recommended various diagnostic tools to determine prognosis or disease severity and evidence-based approach, respectively. For instance, left ventricle (LV) structural or functional alterations, such as elevated natriuretic peptide levels, filling pres sures, or hemodynamic measurements, may support the diagnosis of HFpEF. Further, the use of diuretics, sodium-glucose cotransporter 2 inhibitor (SGLT2i), angiotensin receptor-neprilysin inhibitor (ARNi), mineralocorticoid receptor antagonist (MRA), and angiotensin receptor blocker (ARB) are recommended therapies for the management of patients with HFpEF. However, HFpEF diagnosis and management in developing countries like India is difficult due to nonspecific signs and symptoms (such as fatigue, breathlessness, and swelling in the ankle, etc.), diagnostic uncertainty, existing co-morbidities, and lack of resources to perform additional examinations. Notably, the perception of healthcare professionals (HCPs) towards the diagnosis and management of HFpEF patients also differs due to the existing gap between the guidelines and daily clinical practice. Till date, 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.
Thus, this retrospective, cross-sectional multicenter study is planned to evaluate the prevalence of HFpEF, causes and current therapeutic approach 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.
|