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NCT06363110Completed

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

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

Source: ClinicalTrials.gov · Last updated 3 Jul 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
1400 (actual)
First submitted
9 Apr 2024
Start date
10 Apr 2024
Primary completion date
24 Jun 2024
Lead sponsor
Bayer
NCT number
NCT06363110

What you commit to

  • Study type: Observational
  • Participants enrolled: 1400
  • From 10 Apr 2024 to the primary completion date, 24 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with any open pharmacy claim in the 180-day prior to index date

Age

  • Patients with missing age (last value observed) and gender (last value observed) at index date.

Other

  • Patients with an open pharmacy claim for vericiguat at index date and in the 90 days after index date

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Bayer
Coordinator of this site? Confirm its status
WhippanyUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.