Chronic Heart Failure With Reduced Ejection FractionNCT06632483
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
An observational study of Chronic Heart Failure With Reduced Ejection Fraction and Worsening Chronic Heart Failure, run by Bayer at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure With Reduced Ejection Fraction, Worsening Chronic Heart Failure
- What is being tested?
- Vericiguat (Verquvo, BAY1021189)
- How many people
- 604 participants
- Where
- 1 siteIndia
- Study dates
- 8 Sep 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The primary source of data is hospital medical records. The electronic health records or physical records of patients with HFrEF who were managed with Vericiguat will be screened to obtain the relevant baseline and follow-up data. Such records will be collected from 15 participating sites in India.
Who may be able to join
- 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
Who cannot join
- Subjects who have participated in an interventional clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read more
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.
- Being tested
- Vericiguat (Verquvo, BAY1021189)
- Keywords
- HFrEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat (Verquvo, BAY1021189)Drug
Prescibed as per local label
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat | New users who have been initiated on Vericiguat between 01 Sep 2022 and 31 Aug 2023 in 15 Sites in India Receives: Drug: Vericiguat (Verquvo, BAY1021189) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive measurement of baseline clinical characteristics of patients initiated on Vericiguat
Clinical characteristics include demographics, concomitant medication, medical history and surgical history, history of hospitalization, N-Terminal Pro Brain Natriuretic Peptide (NT-Pro BNP) levels
Measured: At baseline
Descriptive measurement of baseline treatment patterns of patients initiated on Vericiguat
Measured: At baseline
Description of the use of medications of interest (yes/no) before/after initiation of Vericiguat
Includes description of prescribed amount of medications of interest in respective observation periods
Measured: Up to 12 months
Descriptive measurement of titration patterns
Includes starting dose, up-titration / down-titration (yes/no), time until target dose
Measured: Up to 12 months
Descriptive measurement of treatment discontinuation
Includes descriptive analysis of number of patients who have discontinued treatment, time points of discontinuation, reasons for discontinuation (Symptomatic hypotension, syncope)
Measured: Up to 12 months
Secondary outcomes (4)
Number of patients with hospitalizations due to heart failure after Vericiguat initiation
Measured: Up to 12 months
Cardiovascular mortality rate
Measured: Up to 12 months
Composite of heart failure hospitalization and cardiovascular mortality
Measured: Up to 12 months
Number of patients with symptomatic hypotension or syncope after Vericiguat initiation
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start8 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632483
- Sponsor's protocol ID
- 22613
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06632483
- Acronym / sponsor ID
- 22613
- Keywords
- HFrEF
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 604 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vericiguat | – | Drug: Vericiguat (Verquvo, BAY1021189)New users who have been initiated on Vericiguat between 01 Sep 2022 and 31 Aug 2023 in 15 Sites in India |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary source of data is hospital medical records. The electronic health records or physical records of patients with HFrEF who were managed with Vericiguat will be screened to obtain the relevant baseline and follow-up data. Such records will be collected from 15 participating sites in India.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who have participated in an interventional clinical study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vericiguat (Verquvo, BAY1021189)Prescibed as per local label | Drug | Vericiguat |
Primary outcome
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
Descriptive measurement of baseline treatment patterns of patients initiated on Vericiguat
Time frame: At baseline
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
Descriptive measurement of titration patterns
Time frame: Up to 12 months
Includes starting dose, up-titration / down-titration (yes/no), time until target dose
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)
4 secondary outcomes
Number of patients with hospitalizations due to heart failure after Vericiguat initiation
Time frame: Up to 12 months
Cardiovascular mortality rate
Time frame: Up to 12 months
Composite of heart failure hospitalization and cardiovascular mortality
Time frame: Up to 12 months
Number of patients with symptomatic hypotension or syncope after Vericiguat initiation
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Chronic Heart Failure With Reduced Ejection Fraction
RecruitingPhase 3
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction
RecruitingPhase 3
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
Heart Failure
RecruitingPhase 3
Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingPhase 1
Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure
Chronic Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure With Reduced Ejection Fraction and Worsening Chronic Heart Failure, run by Bayer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive measurement of baseline clinical characteristics of patients initiated on Vericiguat (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.