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Chronic heart failure with reduced ejection fraction

Bayer Identifier:

22013

ClinicalTrials.gov Identifier:

NCT06148935

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

19 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
3000
Trial Dates
November 2023 - September 2027
Phase
Phase 4
Could I Receive a placebo
No
Products
Verquvo (Vericiguat, BAY1021189)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many LocationsMany Locations, Korea,_republic_of

Primary Outcome

  • 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)
    date_rangeTime Frame:
    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 Outcome

  • Occurrence of the composite of cardiovascular (CV) death or first hospitalization due to heart failure (HF)
    date_rangeTime Frame:
    From initial visit to final visit, up to 12 months for each participant
  • Occurrence of CV death
    date_rangeTime Frame:
    From initial visit to final visit, up to 12 months for each participant
  • Occurrence of HF hospitalization
    date_rangeTime Frame:
    From initial visit to final visit, up to 12 months for each participant
  • Time to reach different dose levels of Verquvo (Vericiguat) during initial titration
    date_rangeTime Frame:
    From initial visit to final visit, up to 12 months for each participant
  • Relative time on different dose levels of Verquvo (Vericiguat) during follow-up
    date_rangeTime Frame:
    From first follow-up visit to final visit, up to 11 months for each participant

Trial design

Post-marketing surveillance study for Verquvo (Vericiguat) in Korean heart failure patients with reduced ejection fraction
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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