This is an observational study in which data already collected from people with chronic
HFrEF (heart failure with reduced ejection fraction) who have experienced worsening heart
failure are studied.
Chronic HFrEF is a long-term condition where the left side of the heart does not pump
blood out to the body as well as it should. Blood and fluid may collect in the lungs,
blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart
failure can lead to other serious medical conditions that may result in hospital stays
and even death.
The study drug, vericiguat, is already approved for doctors to prescribe to people with
worsening of heart failure with chronic HFrEF in India.
Vericiguat increases the activity of an enzyme called soluble guanylate cyclase (sGC),
which relaxes the blood vessels, allowing more blood to flow through. As a result, the
heart is able to pump better.
The participants in this study are already receiving treatment with vericiguat as part of
their regular care from their doctors. There is currently limited real-world data on the
use of vericiguat. Furthermore, discussing whether vericiguat treatment should start
early in people with heart failure can help doctors manage these people better.
The main purpose of this study is to collect information about how well vericiguat works
and how safe it is in Indian people with chronic HFrEF who have experienced worsening
heart failure. To do this, researchers will collect the following information:
participants' characteristics, including age, sex, height, weight, and medical
history
additional medicines participants have taken with vericiguat
other treatment options participants have taken for the treatment of heart failure
levels of NT-pro BNP* in participants' blood at least one month before taking
vericiguat (*NT-proBNP is made by heart muscles. People with heart diseases have
increased levels of NT-proBNP in their blood. Measuring NT-proBNP levels in the
blood can help doctors identify heart disease.)
number of participants from India, divided into four zones-North, South, East, and
West
categorization of participants based on how heart failure limits physical activity
and classification of heart failure by cause
change in heart function measured by how much blood the left side of the heart can
pump out
number of hospitalizations and number of participants who died due to heart-related
and non-heart-related events
number of participants who experienced low blood pressure or fainting after starting
treatment with vericiguat
participants who discontinued treatment with vericiguat, due to low blood pressure
or fainting
The data will come from the participants' hospital, medical and electronic healthcare
records. Data collected will be from Indian people with chronic HFrEF who started taking
vericiguat between September 2022 and August 2023.
Researchers will track participants' data and will follow them until Feb 2024. In this
study, only available data from routine care are collected. No visits or tests are
required as part of this study.
