Clinical trial NCT06363110: 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
Official title: Titration Patterns, Patient Characteristics and Hypotension Events Among Patients Initiating Vericiguat in Real World Settings in the United States (US)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Keywords: HFrEF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date
timeFrame: Retrospective data analysis from 01Jan2021 to 01Apr2023
measure: Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation
timeFrame: Retrospective data analysis from 01Jan2021 to 01Jul2023
measure: Days from index date to first occurrence of 10 mg/day dose
timeFrame: Retrospective data analysis from 01Jan2021 to 01Jul2023
measure: 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
timeFrame: Retrospective data analysis from 01Jan2021 to 01Jul2023
measure: Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiation
timeFrame: Retrospective data analysis from 01Jan2021 to 01Jul2023
measure: Number of patients having specific titration scenarios within the 90 days after vericiguat initiation
timeFrame: Retrospective data analysis from 01Jan2021 to 01Jul2023
Secondary outcomes:
measure: Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals
timeFrame: Retrospective data analysis from 01Jan2021 to 01Jul2023
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Bayer
state: New Jersey
Study officials:
References: