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

NCT05974189 | Completed

• 1 other identifier: 22562
• Study Type: observational
• Target: 1,391
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Keywords

HFrEF

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (3)

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

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

• First ER visit or hospitalization for HF

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

• All-cause death

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

Study Arms (2)

HFrEF patients treated with at least one GDMT and with vericiguat

This study will use anonymized real-world data from HealthVerity closed Medical and Pharmacy Claims. Adult patients with a diagnosis of HFrEF and received vericiguat added to at least one guideline directed medical therapy (GDMT), from January 1, 2021 through June 30, 2023 will be included in this retrospective cohort analysis.

HFrEF patients treated with at least one GDMT, without vericiguat

This study will use anonymized real-world data from HealthVerity closed Medical and Pharmacy Claims. Adult patients with a diagnosis of HFrEF and received at least one GDMT (without vericiguat), from January 1, 2021 through June 30, 2023 will be included in this retrospective cohort analysis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort analysis in data from the deidentified, United States HealthVerity (HV) Claims, Pharmacy.

You may qualify if:

• ≥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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Berlin, 13342, Germany

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: July 11, 2023
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)