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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure With Reduced Ejection Fraction

• Study Type: Observational
• Enrollment (Actual): 1391

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13342
    • Bayer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Actual): October 8, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: HFrEF
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 22562

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No