account_circleRecruiting
Chronic heart failure with reduced ejection fraction
Bayer Identifier:
22013
ClinicalTrials.gov Identifier:
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.
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
AllAge
19 - N/ATrial summary
Enrollment Goal
3000Trial Dates
November 2023 - September 2027Phase
Phase 4Could I Receive a placebo
NoProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many Locations | Many 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 deathdate_rangeTime Frame:From initial visit to final visit, up to 12 months for each participant
- Occurrence of HF hospitalizationdate_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 titrationdate_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-update_rangeTime Frame:From first follow-up visit to final visit, up to 11 months for each participant
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A