check_circleStudy Completed
Chronic heart failure with reduced ejection fraction
Bayer Identifier:
22562
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
This is an observational study in which the health data of people with chronic heart failure with reduced ejection fraction (HFrEF) are collected using administrative claims data.
In observational studies, only observations are made and participants do not receive any advice or changes to healthcare.
Chronic HFrEF is a longterm condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death.
Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better.
Vericiguat was approved for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. There is limited information available about the use of vericiguat for the treatment of HFrEF under realworld conditions.
The main purpose of this study is to collect information about the characteristics of people with HFrEF, who are on vericiguat in addition to at least one standard treatment. Researchers will collect information about participants’ basic characteristics, including their age, gender, other health conditions they may have, and the medicines they may be taking.
The data will come from administrative claims data for people in the United States of America who were diagnosed with HFrEF between January 2020 and June 2022.
In this study, only available data from routine care is collected. No visits or tests are required as part of this study.
In observational studies, only observations are made and participants do not receive any advice or changes to healthcare.
Chronic HFrEF is a longterm condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death.
Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better.
Vericiguat was approved for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. There is limited information available about the use of vericiguat for the treatment of HFrEF under realworld conditions.
The main purpose of this study is to collect information about the characteristics of people with HFrEF, who are on vericiguat in addition to at least one standard treatment. Researchers will collect information about participants’ basic characteristics, including their age, gender, other health conditions they may have, and the medicines they may be taking.
The data will come from administrative claims data for people in the United States of America who were diagnosed with HFrEF between January 2020 and June 2022.
In this study, only available data from routine care is collected. No visits or tests are required as part of this study.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
1391Trial Dates
July 2023 - October 2024Phase
Phase 4Could I Receive a placebo
N/AProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Active, not recruiting | Bayer | Berlin, 13342, Germany |
Primary Outcome
- Descriptive summary of baseline characteristics of new users administered vericiguat in addition to at least one GDMT in patients with HFrEFdate_rangeTime Frame:Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023
Secondary Outcome
- First hospitalization for HF or all cause of death or first emergency room visit (ER)date_rangeTime Frame:Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023
- First ER visit or hospitalization for HFdate_rangeTime Frame:Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023
- All-cause deathdate_rangeTime Frame:Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023
Trial design
Trial Type
ObservationalIntervention Type
N/ATrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A