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NCT Number: 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

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.

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Key information

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Berlin, 13342, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Descriptive summary of baseline characteristics of new users administered vericiguat in addition to at least one GDMT in patients with HFrEF

    Time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023

Secondary outcomes

  1. First hospitalization for HF or all cause of death or first emergency room visit (ER)

    Time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023

  2. First ER visit or hospitalization for HF

    Time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023

  3. All-cause death

    Time frame: Retrospective cohort analysis from 01-Jan-2018 to 30-Jun-2023

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2023
Registry last updated
Nov 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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