An Observational Study to Learn More About How Safe Vericiguat is and How Well it Works in Indian People With Chronic Heart Failure With Reduced Ejection Fraction and Worsening Chronic Heart Failure Under Real World Conditions

Bayer

Status

Active, not recruiting

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Worsening Chronic Heart Failure

Treatments

Drug: Vericiguat (Verquvo, BAY1021189)

Study type

Observational

Funder types

Industry

Identifiers

NCT06632483

22613

Details and patient eligibility

About

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.

Enrollment

1,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of ≥18 years age.
Patients who are prescribed as per local label will be included in the study
At least one Vericiguat prescription during the time between 01 Sep 2022 and 31 Aug 2023

Exclusion criteria