Chronic Heart Failure With Reduced Ejection FractionPhase 4NCT05658458
A Study to Learn How Well the Drug Vericiguat Works and How Safe it is Under Real World Conditions in Indian Participants After Worsening of a Long-term Heart Condition in Which the Left Side of the Heart Does Not Pump Blood as Well as it Should (Chronic Heart Failure With Reduced Ejection Fraction)
A Phase 4 study testing Vericiguat (Verquvo, BAY1021189) in people with Chronic Heart Failure With Reduced Ejection Fraction and Worsening Heart Failure, run by Bayer at 12 sites in India.
Trial summary
Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction (HFrEF). 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. 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 Heart Failure
- What is being tested?
- Vericiguat (Verquvo, BAY1021189)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 12 sitesIndia
- Study dates
- 16 Dec 2022to 19 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
Who may be able to join
- Male or female participants aged ≥18 years at the time point of signing ICF
- Has a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying HF decompensation
- Has chronic HF with reduced LVEF (<45%) after a WHF event (defined as HF hospitalization or use of iv diuretics for HF [without hospitalization])
- Is capable of giving signed ICF and willing to comply with the study-related procedures
- Female participants in the following categories:
- A female who is not of reproductive potential, defined as a female who either: (a) is postmenopausal (defined as at least 12 months with no menses in women ≥45 years of age); (b) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to Screening; or (c) has a congenital or acquired condition that prevents childbearing
- A female who is of reproductive potential and agrees to avoid becoming pregnant while receiving the study drug and for 14 days after the last dose of the study drug by complying with one of the following: (a) practice abstinence from heterosexual activity or (b) use (and have her partner use) acceptable, highly effective contraception methods during heterosexual activity.
Who cannot join
- Is clinically unstable at the time of screening defined by:
- Administration of any iv treatment within 24 hours until start of study intervention, and/or
- SBP < 100 mmHg or symptomatic hypotension.
- Has concurrent or anticipated use of PDE5 inhibitors, or a sGC stimulator such as riociguat.
- Has known allergy or hypersensitivity to any sGC stimulator.
- Has severe hepatic insufficiency such as with hepatic encephalopathy.
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- Has severe renal impairment with eGFR < 15 mL/min/1.73m*2 (calculated based on the MDRD equation) or on dialysis.
- Is pregnant or breast feeding or plans to become pregnant or to breastfeed during the course of the trial.
- Participated in another interventional clinical study and treatment with another investigational product ≤ 30 days prior to screening.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
India12 sites
Sanjivani Super Speciality Hospital
Ahmedabad, Gujarat, 380015
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
Apollo Hospital Tondiarpet
Chennai, Tamil N?du, 600081
Lisie Hospital
Kochi, Kerala, 682017
Apollo Gleneagles Hospital Limited
Kolkata, 700054
Deep Hospital
Ludhiana, Punjab, 141002
Kokilaben Dhirubhai Ambani Hospital & Medical Research Insti
Mumbai, Maharashtra, 400053
Vijan Cardiac & Critical Care Centre
Nashik, Maharashtra, 422005
Max Super Speciality Hospital, Saket
New Delhi, National Capital Territory of Delhi, 110017
Safdarjung Hospital
New Delhi, National Capital Territory of Delhi, 110029
Krishna Institute Of Medical Science
Secunderabad, Andhra Pradesh, 500 003
Rhythm Heart Institute
Vadodara, Gujarat, 390022
About this study
Official title: A Phase IV Interventional Post Approval Trial to Investigate Effectiveness and Safety of Vericiguat Therapy in Indian Patients With Chronic Heart Failure With Reduced Ejection Fraction After a Worsening Heart Failure Event.
Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction (HFrEF).
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 death. Despite various available treatments for long-term HFrEF, people may experience worsening of their condition, called worsening heart failure events. Worsening heart failure events require the patient to either stay in the hospital or receive special treatment to remove excess water from the body.
Read more
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps to regulate the heart and blood circulation. Vericiguat was recently approved in India for doctors to prescribe to people with HFrEF after they had a worsening heart failure event, with a request to specifically gather information on vericiguat therapy in Indians.
Therefore, the main purpose of this study is to learn more about how well vericiguat works in Indian people with HFrEF who receive vericiguat after a worsening heart failure event. Work well means to prevent:
- death due to heart and circulatory events, or
- hospital stays. Researchers will collect the number of participants treated with vericiguat who have either of this.
To find out how safe vericiguat is, researchers will also collect the number of participants who have medical problems during the study. Doctors keep track of all medical problems, even if they do not think the adverse events might be related to the study treatments.
The participants will take vericiguat as tablet by mouth and as prescribed by their doctors according to the local label.
Each participant will be in the study for approximately 1 year including a screening period of up to 1 month. Up to 8 visits to the study site are planned.
During the study, the study team will:
- check vital signs
- do physical examinations
- examine heart health using electrocardiogram ECG and if needed echocardiography
- take blood and urine samples
- Being tested
- Vericiguat (Verquvo, BAY1021189)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat (Verquvo, BAY1021189)Drug
The recommended starting dose of vericiguat is 2.5 mg once daily, taken with food. The dose of vericiguat would be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the participant.
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat therapy | Experimental | Adult participants with chronic HFrEF who are naïve to vericiguat and will be prescribed vericiguat as per local label by their treating physician (cardiologists). Receives: Drug: Vericiguat (Verquvo, BAY1021189) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of the composite of CV death or first hospitalization due to HF
Measured: 14 days after end of treatment (EoT) visit (month 12) +1 week
Secondary outcomes (5)
Occurrence of CV death
Measured: 14 days after end of treatment (EoT) visit (month 12) +1 week
Occurrence of first HF hospitalization
Measured: 14 days after end of treatment (EoT) visit (month 12) +1 week
Occurrence of the composite of death due to all causes or first HF hospitalization
Measured: 14 days after end of treatment (EoT) visit (month 12) +1 week
Occurrence of death due to all causes
Measured: 14 days after end of treatment (EoT) visit (month 12) +1 week
Occurrence of adverse events (AEs), serious adverse events (SAEs), study interventionrelated AEs will be listed
Measured: 14 days after end of treatment (EoT) visit (month 12) +1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start16 Dec 2022
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658458
- Sponsor's protocol ID
- 22144
- Status last verified
- Oct 2024
- First submitted
- 12 Dec 2022
- Last updated
- 8 Oct 2024
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Interventional Post Approval Trial to Investigate Effectiveness and Safety of Vericiguat Therapy in Indian Patients With Chronic Heart Failure With Reduced Ejection Fraction After a Worsening Heart Failure Event.
- ClinicalTrials.gov ID
- NCT05658458
- Acronym / sponsor ID
- 22144
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2022 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 20 Dec 2022 (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.
Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction (HFrEF).
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 death. Despite various available treatments for long-term HFrEF, people may experience worsening of their condition, called worsening heart failure events. Worsening heart failure events require the patient to either stay in the hospital or receive special treatment to remove excess water from the body.
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps to regulate the heart and blood circulation. Vericiguat was recently approved in India for doctors to prescribe to people with HFrEF after they had a worsening heart failure event, with a request to specifically gather information on vericiguat therapy in Indians.
Therefore, the main purpose of this study is to learn more about how well vericiguat works in Indian people with HFrEF who receive vericiguat after a worsening heart failure event. Work well means to prevent:
- death due to heart and circulatory events, or
- hospital stays. Researchers will collect the number of participants treated with vericiguat who have either of this.
To find out how safe vericiguat is, researchers will also collect the number of participants who have medical problems during the study. Doctors keep track of all medical problems, even if they do not think the adverse events might be related to the study treatments.
The participants will take vericiguat as tablet by mouth and as prescribed by their doctors according to the local label.
Each participant will be in the study for approximately 1 year including a screening period of up to 1 month. Up to 8 visits to the study site are planned.
During the study, the study team will:
- check vital signs
- do physical examinations
- examine heart health using electrocardiogram ECG and if needed echocardiography
- take blood and urine samples
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vericiguat therapy | Experimental | Drug: Vericiguat (Verquvo, BAY1021189)Adult participants with chronic HFrEF who are naïve to vericiguat and will be prescribed vericiguat as per local label by their treating physician (cardiologists). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female participants aged ≥18 years at the time point of signing ICF
- Has a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying HF decompensation
- Has chronic HF with reduced LVEF (<45%) after a WHF event (defined as HF hospitalization or use of iv diuretics for HF [without hospitalization])
- Is capable of giving signed ICF and willing to comply with the study-related procedures
- Female participants in the following categories:
Key exclusion criteria (9 listed)
- Is clinically unstable at the time of screening defined by:
- Has concurrent or anticipated use of PDE5 inhibitors, or a sGC stimulator such as riociguat.
- Has known allergy or hypersensitivity to any sGC stimulator.
- Has severe hepatic insufficiency such as with hepatic encephalopathy.
- Has severe renal impairment with eGFR < 15 mL/min/1.73m*2 (calculated based on the MDRD equation) or on dialysis.
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)The recommended starting dose of vericiguat is 2.5 mg once daily, taken with food. The dose of vericiguat would be doubled approximately every 2 weeks to reach the target maintenance dose of 10 mg once daily, as tolerated by the participant. | Drug | Vericiguat therapy |
Primary outcome
Occurrence of the composite of CV death or first hospitalization due to HF
Time frame: 14 days after end of treatment (EoT) visit (month 12) +1 week
5 secondary outcomes
Occurrence of CV death
Time frame: 14 days after end of treatment (EoT) visit (month 12) +1 week
Occurrence of first HF hospitalization
Time frame: 14 days after end of treatment (EoT) visit (month 12) +1 week
Occurrence of the composite of death due to all causes or first HF hospitalization
Time frame: 14 days after end of treatment (EoT) visit (month 12) +1 week
Occurrence of death due to all causes
Time frame: 14 days after end of treatment (EoT) visit (month 12) +1 week
Occurrence of adverse events (AEs), serious adverse events (SAEs), study interventionrelated AEs will be listed
Time frame: 14 days after end of treatment (EoT) visit (month 12) +1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vericiguat (Verquvo, BAY1021189) in people with Chronic Heart Failure With Reduced Ejection Fraction and Worsening Heart Failure, run by Bayer at 12 sites 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of the composite of CV death or first hospitalization due to HF (time frame: 14 days after end of treatment (EoT) visit (month 12) +1 week). 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 8 Oct 2024.