Clinical trial 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
Official title: Assessing Vericiguat for the Management of Heart Failure With Reduced Ejection Fraction Using HealthVerity Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Keywords: HFrEF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-08-03
Enrollment: 1391
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort analysis in data from the deidentified, United States HealthVerity (HV) Claims, Pharmacy.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* ≥18-years old and have at least one year of continous enrollment in the HV database.
* 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.

Primary outcomes:
measure: Descriptive summary of baseline characteristics of new users administered vericiguat in addition to at least one GDMT in patients with HFrEF
timeFrame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023
Secondary outcomes:
measure: First hospitalization for HF or all cause of death or first emergency room visit (ER)
timeFrame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023
measure: First ER visit or hospitalization for HF
timeFrame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023
measure: All-cause death
timeFrame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Bayer
Study officials:
References: