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

Chronic Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

Assessing Vericiguat for the Management of Heart Failure With Reduced Ejection Fraction Using HealthVerity Data

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05974189
• Other study ID #: 22562
• Status: Active, not recruiting
• Start date: July 11, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: June 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18-years old

• Have proven or presumed HFrEF

• Have received =1 GDMTs for HFrEF

• All patients will be required to have continuous enrollment in the HealthVerity data set during the pre-index date (baseline period) of at least 90-days.

Related Conditions & MeSH terms

• Chronic Heart Failure With Reduced Ejection Fraction
• Heart Failure

Locations

Country	Name	City	State
Germany	Bayer	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive summary of baseline characteristics of patients administered vericiguat in addition to at least one GDMT in patients with HFrEF		Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
Secondary	Time tovisit or first hospitalization for HF or cardiovascular (CV) death first emergency room (ER)		Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
Secondary	Time to CV mortality		Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
Secondary	Time to first ER visit or hospitalization for HF		Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022
Secondary	Time to all-cause death		Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2022

External Links

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