Trial Condition(s):
Chronic heart failure with reduced ejection fraction
An observational study called ROVER to learn more about how well vericiguat works in people who were newly treated with vericiguat in routine medical care in Germany (ROVER)
Bayer Identifier:
22829
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
This is an observational study in which data already collected from people treated with vericiguat are studied.
In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is 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 common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death.
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 through. As a result, the heart is able to pump better.
Vericiguat is available in Germany for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. However, there is limited information available about the use of vericiguat for the treatment of HFrEF under real-world conditions in routine medical care.
The main purpose of this study is to collect information about how well vericiguat works in people with HFrEF who were newly treated with vericiguat. In addition, researchers will collect information about participants’ basic characteristics, including their age, gender, other health conditions they might have, and the medicines they might be taking.
The data will come from 2 German health databases including people who newly started vericiguat treatment between September 2021 and September 2023.
Inclusion Criteria
- Patients with an initial prescription of Vericiguat (index date) according to ATC Code C01DX22. - At least 18 years or older on the initial prescription of Vericiguat.
Exclusion Criteria
- No exclusion criteria for any population will be applied.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Bayer Wuppertal, Germany, 42096 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Real World Outcomes of Patients Treated with Vericiguat in German Routine Care
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- All-cause mortality rates after initiation of vericiguatNumber of patients who died between the “Vericiguat index date” and “cohort exit” according to their death date.Timeframe: Between September 2021 and September 2023
- All-cause related hospitalization rates after initiation of vericiguatSum of all fully hospitalized cases of all patients between the “Vericiguat index date” and “cohort exit”.Timeframe: Between September 2021 and September 2023
- Heart failure related hospitalization rates after initiation of vericiguatSum of all fully hospitalized cases with a main or secondary inpatient diagnosis according to ICD-10 GM Code I50.x or I11.0 between the “Vericiguat index date” and “cohort exit”.Timeframe: Between September 2021 and September 2023
Secondary Outcome
- Adherence of vericiguat drug useAdherence will be assessed using the Medical Possession Ratio (MPR=days of supply/treatment duration).Timeframe: Between September 2021 and September 2023
- Titration pattern of vericiguat drug useTitration patterns will be assessed by investigating indicators such as the starting dose, the maximum dose reached as well as the time until up-titration.Timeframe: Between September 2021 and September 2023
- Patient persistence of vericiguat drug usePersistence will be calculated via the time until discontinuation of vericiguat.Timeframe: Between September 2021 and September 2023
- Socio-demographic characteristics of patients initiating vericiguat at baselineSex and age groups.Timeframe: Between September 2021 and September 2023
- Clinical characteristics of patients initiating vericiguat at baselinePre-defined comorbidities, pre-defined comedications, all-cause hospitalization, worsening hart failure event, etc.Timeframe: Between September 2021 and September 2023
- Medication of interest in the 3 months before and after initiation of vericiguatTimeframe: Between September 2021 and September 2023
Additional Information
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