Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

VERQUVO

Study drug International non-proprietary name (INN) or common name

VERICIGUAT

Anatomical Therapeutic Chemical (ATC) code

(C01) CARDIAC THERAPY
CARDIAC THERAPY

Medical condition to be studied

Cardiac failure chronic

Additional medical condition(s)

Chronic heart failure with reduced ejection fraction (HFrEF)
Population studied

Short description of the study population

All patients with their first vericiguat prescription since market authorization in September 2021 who are aged 18 years or older will be included in the study.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

500
Study design details

Study design

A retrospective single-arm cohort study including new users of vericiguat between SEP 2021 and SEP 2023 will be conducted.

Main study objective

Describe occurrence of effectiveness outcomes in patients initiating vericiguat

Outcomes

Primary Outcomes:
- All-cause mortality rates after initiation of vericiguat
- All-cause related hospitalization rates after initiation of vericiguat
- Heart failure related hospitalization rates after initiation of vericiguat

Secondary Outcomes:
- Adherence of vericiguat drug use
- Titration pattern of vericiguat drug use
- Patient persistence of vericiguat drug use
- Socio-demographic characteristics of patients initiating vericiguat at baseline
- Clinical characteristics of patients initiating vericiguat at baseline
- Medication of interest in the 3 months before and after initiation of vericiguat

Data analysis plan

All analyses will be purely explorative with no a priori defined hypothesis.
Occurrence of the primary composite outcomes will be described as absolute numbers, frequencies, rates per person time as well as in a time to event manner.
Adherence and titration patterns will only be analyzed via absolute numbers and percentages.
The time until discontinuation will additionally be described in a time to event manner.
Factors influencing the occurrence of outcomes will be explored by adequate regression models.