Clinical trial NCT06148935: An Observational Study to Learn More About the Use of Vericiguat in Korean People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in Real-world Setting
Official title: Post-marketing Surveillance Study for Verquvo (Vericiguat) in Korean Heart Failure Patients With Reduced Ejection Fraction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female and male participants with a diagnosis of heart failure with reduced ejection fraction (HFrEF) will be enrolled after the decision for treatment with Verquvo (Vericiguat) has been made by the investigator´s discretion.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 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 outcomes:
measure: Occurrence of the composite of cardiovascular (CV) death or first hospitalization due to heart failure (HF)
timeFrame: From initial visit to final visit, up to 12 months for each participant
measure: Occurrence of CV death
timeFrame: From initial visit to final visit, up to 12 months for each participant
measure: Occurrence of HF hospitalization
timeFrame: From initial visit to final visit, up to 12 months for each participant
measure: Time to reach different dose levels of Verquvo (Vericiguat) during initial titration
timeFrame: From initial visit to final visit, up to 12 months for each participant
measure: Relative time on different dose levels of Verquvo (Vericiguat) during follow-up
timeFrame: From first follow-up visit to final visit, up to 11 months for each participant
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
facility: Many Locations
Study officials:
References: