Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial
Official title:
Post-marketing Surveillance Study for Verquvo (Vericiguat) in Korean Heart Failure Patients With Reduced Ejection Fraction
NCT number | NCT06148935 |
Other study ID # | 22013 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 30, 2023 |
Est. completion date | September 30, 2027 |
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in people with chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition in which the heart does not pump blood 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. The study treatment vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). sGC helps to regulate the heart and blood circulation. Vericiguat has already been studied in previous clinical studies and is available for doctors to prescribe to people with heart failure. This study will collect important data from real-world setting in Korea. The participants of this study are people with HFrEF who will receive vericiguat as prescribed by their doctors according to the approved product information. The main purpose of this study is to learn more about how safe vericiguat is in the participants. To do this, researchers will collect data on all medical problems (also called adverse events) that the participants have during the study. Doctors keep track of all adverse events, even if they do not think they might be related to the study treatment. Further, researchers will collect data on how well vericiguat works and treatment patterns in the participants. For this, the following information will be collected: - occurrence of death due to heart and circulatory events - hospital stays due to heart conditions (failure) - dose levels of vericiguat and duration of treatment The data for this study will come from medical records and visits that take place in routine practice. Participants will be treated with vericiguat and observed up to 12 months or until death or they leave the study, whatever comes first.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | September 30, 2027 |
Est. primary completion date | March 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - Adult aged 19 years or older - Chronic HF (NYHA functional class II, III, or IV) Reduced left ventricular ejection fraction (< 45%) within 12 months before enrollment - Worsening of heart failure (hospitalized within 6 months before enrollment or intravenous diuretic therapy without hospitalization within 3 months) - Participants who have been prescribed Verquvo (Vericiguat) as per locally approved label and didn't receive Verquvo (Vericiguat) therapy previously. - Written informed consent from subject or legal representative; assent from subject when appropriate Exclusion Criteria: - Contraindication according to the local authorized label (including known hypersensitivity to the drug substance or any of its components, pregnancy) - Participants participating in an investigational program with interventions outside of routine clinical practice |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Many Locations | Multiple Locations |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), unexpected adverse events (unexpected AEs) and unexpected adverse drug reactions (unexpected ADRs) | From the date first administration of Verquvo (Vericiguat) to 14 days after the end of the treatment period, up to 12 months for each participant | ||
Secondary | Occurrence of the composite of cardiovascular (CV) death or first hospitalization due to heart failure (HF) | From initial visit to final visit, up to 12 months for each participant | ||
Secondary | Occurrence of CV death | From initial visit to final visit, up to 12 months for each participant | ||
Secondary | Occurrence of HF hospitalization | From initial visit to final visit, up to 12 months for each participant | ||
Secondary | Time to reach different dose levels of Verquvo (Vericiguat) during initial titration | From initial visit to final visit, up to 12 months for each participant | ||
Secondary | Relative time on different dose levels of Verquvo (Vericiguat) during follow-up | From first follow-up visit to final visit, up to 11 months for each participant |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02861534 -
A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-001)
|
Phase 3 | |
Completed |
NCT02226120 -
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction
|
Phase 3 | |
Active, not recruiting |
NCT05093933 -
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (MK-1242-035)
|
Phase 3 | |
Completed |
NCT04836182 -
A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Participants With Chronic Heart Failure With Reduced Ejection Fraction
|
Phase 2 | |
Recruiting |
NCT04983043 -
Efficacy and Safety of QiShen YiQi Dripping Pills in Chronic Heart Failure
|
Phase 2 | |
Completed |
NCT04840914 -
A Study of LY3461767 in Participants With Chronic Heart Failure With Reduced Ejection Fraction
|
Phase 1 | |
Completed |
NCT02768298 -
Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction.
|
Phase 4 | |
Active, not recruiting |
NCT05974189 -
The VERIFY Study: An Observational Study Called VERIFY to Learn More About the Use of Vericiguat in People With Chronic Heart Failure With Reduced Ejection Fraction
|
||
Recruiting |
NCT05553886 -
S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
|
Phase 3 | |
Completed |
NCT02900378 -
randOmized stUdy Using acceleromeTry to Compare Sacubitril/valsarTan and Enalapril in Patients With Heart Failure
|
Phase 3 | |
Withdrawn |
NCT04464525 -
Omecamtiv Mecarbil Post-trial Access Study
|
Phase 3 | |
Recruiting |
NCT05658458 -
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)
|
Phase 4 | |
Recruiting |
NCT05728502 -
An Observational Study, Called VERI-China, to Learn More About How Well Vericiguat Works and How Safe it is in Real-world Setting in People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in China
|
||
Recruiting |
NCT06195930 -
A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction
|
Phase 2 | |
Active, not recruiting |
NCT06363110 -
An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States
|