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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email clinical-trials-contact@bayer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Chronic Heart Failure With Reduced Ejection Fraction
  • Heart Failure

Intervention

Drug:
Vericiguat (Verquvo, BAY1021189)
Following the manner of observational study, no intervention will be provided in the study. Participants follow locally approved label, without interference by the study initiator or study protocol

Locations

Country Name City State
Korea, Republic of Many Locations Multiple Locations

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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
See also
  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