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Chronic heart failure with reduced ejection fraction, Worsening chronic heart failure
Bayer Identifier:
22613
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
1200Trial Dates
May 2025 - October 2025Phase
Phase 4Could I Receive a placebo
NoProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Not yet recruiting | Many locations | Many locations, India |
Primary Outcome
- Descriptive measurement of baseline clinical characteristics of patients initiated on VericiguatClinical characteristics include demographics, concomitant medication, medical history and surgical history, history of hospitalization, N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) levelsdate_rangeTime Frame:At baseline
- Descriptive measurement of baseline treatment patterns of patients initiated on Vericiguatdate_rangeTime Frame:At baseline
- Description of the use of medications of interest (yes/no) before/after initiation of VericiguatIncludes description of prescribed amount of medications of interest in respective observation periodsdate_rangeTime Frame:Up to 12 months
- Descriptive measurement of titration patternsIncludes starting dose, up-titration / down-titration (yes/no), time until target dosedate_rangeTime Frame:Up to 12 months
- Descriptive measurement of treatment discontinuationIncludes descriptive analysis of number of patients who have discontinued treatment, time points of discontinuation, reasons for discontinuation (Symptomatic hypotension, syncope)date_rangeTime Frame:Up to 12 months
Secondary Outcome
- Number of patients with hospitalizations due to heart failure after Vericiguat initiationdate_rangeTime Frame:Up to 12 months
- Cardiovascular mortality ratedate_rangeTime Frame:Up to 12 months
- Composite of heart failure hospitalization and cardiovascular mortalitydate_rangeTime Frame:Up to 12 months
- Number of patients with symptomatic hypotension or syncope after Vericiguat initiationdate_rangeTime Frame:Up to 12 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
Health Services ResearchAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A