An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States (HOVER)

Titration Patterns, Patient Characteristics and Hypotension Events Among Patients Initiating Vericiguat in Real World Settings in the United States (US)

This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied.

In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.

Chronic HFrEF is a long-term condition in which the heart becomes 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 study treatment, 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. As a result, the heart can pump better.

It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment.

The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors.

The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat:

• starting dose of vericiguat
• daily changes in dosage pattern
• time taken to reach the target dose
• number and percentage of participants:
• with specific changes in dosage pattern
• reaching the target dose of vericiguat

They will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF.

The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericiguat between January 2021 and April 2023.

Researchers will only look at the health records of participants in the US.

Researchers will track participants' data and will collect information for a maximum of 6 months before and 3 months after their first dose of vericiguat.

In this study, only available data from routine care are collected. No visits or tests are required as part of this study.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Drug: Vericiguat (Verquvo, BAY1021189)

• Study Type: Observational
• Enrollment (Actual): 1400

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Bayer

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients who initiated vericiguat from closed claims during 01Jan2021 and 01Apr2023 and who have at least 6 months of prior observability.

Description

Inclusion Criteria:

• Patients with a first vericiguat fill from a closed pharmacy claim, defined as the index date, during the patient identification period spanning from 01 JAN 2021 - 01 APR 2023.
• Patients aged 18 years or older at index date.
• Patients with at least 180 days of medical and pharmacy enrollment (no gap) prior to index date (inclusive).

Exclusion Criteria:

• Patients with any open pharmacy claim in the 180-day prior to index date
• Patients with an open pharmacy claim for vericiguat at index date and in the 90 days after index date
• Patients with missing age (last value observed) and gender (last value observed) at index date.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients initiating vericiguat; Adult patients initiating vericiguat in the US. Retrospective single-arm cohort analysis using HealthVerity Heart Failure (HF) dataset licensed by Bayer.	Drug: Vericiguat (Verquvo, BAY1021189); Follow clinical practice/administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date		Retrospective data analysis from 01Jan2021 to 01Apr2023
Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation		Retrospective data analysis from 01Jan2021 to 01Jul2023
Days from index date to first occurrence of 10 mg/day dose		Retrospective data analysis from 01Jan2021 to 01Jul2023
Number of patients who received a dose of 2.5 mg/day, 5 mg/day and 10 mg/day, or discontinued drug therapy each day over the 90-day follow-up period		Retrospective data analysis from 01Jan2021 to 01Jul2023
Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiation	Vericiguat up-titration is defined as first vericiguat prescription with a higher dose compared to the previous vericiguat prescription: 2.5 mg/day at index date followed by any dose >2.5 mg/day during follow-up, OR; 5 mg/day at index date followed by any dose >5 mg/day during follow-up	Retrospective data analysis from 01Jan2021 to 01Jul2023
Number of patients having specific titration scenarios within the 90 days after vericiguat initiation	7 titration patterns: Vericiguat dose of 2.5 mg/day at index date, without 5 mg/day dose and without 10 mg/day dose observed during follow-up; Vericiguat dose of 2.5 mg/day at index date followed by 5.0 mg/day dose during follow-up and without 10 mg/day dose observed during follow-up; Vericiguat dose of 2.5 mg/day at index date, followed by 5 mg/day dose, and followed by 10 mg/day dose during follow-up; Vericiguat dose of 5.0 mg/day at index date without 10 mg/day dose observed during follow-up; Vericiguat dose of 5 mg/day at index date followed by 10 mg/day dose during follow-up; Vericiguat dose of 2.5 mg/day at index date, followed by 10 mg/day dose and without 5 mg/day dose observed during follow-up; Vericiguat dose of 10 mg/day at index date without 2.5 mg/day dose and without 5 mg/day dose observed during follow-up	Retrospective data analysis from 01Jan2021 to 01Jul2023

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals	Retrospective data analysis from 01Jan2021 to 01Jul2023

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): April 10, 2024
• Primary Completion (Actual): June 24, 2024
• Study Completion (Actual): June 24, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: HFrEF
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 22724

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