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NCT Number: NCT06632483

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Heart Failure With Reduced Ejection Fraction Worsening Chronic Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Subjects who have participated in an interventional clinical study

Treatment and study plan

Vericiguat (Verquvo, BAY1021189)

Drug

Prescibed as per local label

Primary outcomes

  1. Descriptive measurement of baseline clinical characteristics of patients initiated on Vericiguat

    Time frame: At baseline

    Clinical characteristics include demographics, concomitant medication, medical history and surgical history, history of hospitalization, N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) levels

  2. Descriptive measurement of baseline treatment patterns of patients initiated on Vericiguat

    Time frame: At baseline

  3. Description of the use of medications of interest (yes/no) before/after initiation of Vericiguat

    Time frame: Up to 12 months

    Includes description of prescribed amount of medications of interest in respective observation periods

  4. Descriptive measurement of titration patterns

    Time frame: Up to 12 months

    Includes starting dose, up-titration / down-titration (yes/no), time until target dose

  5. Descriptive measurement of treatment discontinuation

    Time frame: Up to 12 months

    Includes descriptive analysis of number of patients who have discontinued treatment, time points of discontinuation, reasons for discontinuation (Symptomatic hypotension, syncope)

Secondary outcomes

  1. Number of patients with hospitalizations due to heart failure after Vericiguat initiation

    Time frame: Up to 12 months

  2. Cardiovascular mortality rate

    Time frame: Up to 12 months

  3. Composite of heart failure hospitalization and cardiovascular mortality

    Time frame: Up to 12 months

  4. Number of patients with symptomatic hypotension or syncope after Vericiguat initiation

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Retrospective, Non-interventional Database Study for the Evaluation of Real-world Drug Use Patterns, Clinical Characteristics and Clinical Outcomes in Patients Initiated on Vericiguat in India

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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