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)

Bayer

Status: Completed

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Vericiguat (Verquvo, BAY1021189)

Study type: Observational

Funder types: Industry

Identifiers

NCT06363110

22724

Details and patient eligibility

About

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.

Enrollment: 1,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,400 participants in 1 patient group

Adult patients initiating vericiguat

Description:

Adult patients initiating vericiguat in the US. Retrospective single-arm cohort analysis using HealthVerity Heart Failure (HF) dataset licensed by Bayer.

Treatment:

Drug: Vericiguat (Verquvo, BAY1021189)