A Phase IV Interventional Post Approval Trial to Investigate Effectiveness and Safety of Vericiguat Therapy in Indian Patients With Chronic Heart Failure With Reduced Ejection Fraction After a Worsening Heart Failure Event.
A Phase IV Interventional Post Approval Trial to Investigate Effectiveness and Safety of Vericiguat Therapy in Indian Patients With Chronic Heart Failure With Reduced Ejection Fraction After a Worsening Heart Failure Event.
Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction (HFrEF).
HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death. Despite various available treatments for long-term HFrEF, people may experience worsening of their condition, called worsening heart failure events. Worsening heart failure events require the patient to either stay in the hospital or receive special treatment to remove excess water from the body.
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps to regulate the heart and blood circulation. Vericiguat was recently approved in India for doctors to prescribe to people with HFrEF after they had a worsening heart failure event, with a request to specifically gather information on vericiguat therapy in Indians.
Therefore, the main purpose of this study is to learn more about how well vericiguat works in Indian people with HFrEF who receive vericiguat after a worsening heart failure event. Work well means to prevent:
To find out how safe vericiguat is, researchers will also collect the number of participants who have medical problems during the study. Doctors keep track of all medical problems, even if they do not think the adverse events might be related to the study treatments.
The participants will take vericiguat as tablet by mouth and as prescribed by their doctors according to the local label.
Each participant will be in the study for approximately 1 year including a screening period of up to 1 month. Up to 8 visits to the study site are planned.
During the study, the study team will:
Inclusion Criteria:
Male or female participants aged ≥18 years at the time point of signing ICF
Has a history of chronic HF (NYHA class II-IV) on standard therapy before qualifying HF decompensation
Has chronic HF with reduced LVEF (<45%) after a WHF event (defined as HF hospitalization or use of iv diuretics for HF [without hospitalization])
Is capable of giving signed ICF and willing to comply with the study-related procedures
Female participants in the following categories:
Exclusion Criteria:
Is clinically unstable at the time of screening defined by:
Has concurrent or anticipated use of PDE5 inhibitors, or a sGC stimulator such as riociguat.
Has known allergy or hypersensitivity to any sGC stimulator.
Has severe hepatic insufficiency such as with hepatic encephalopathy.
Has severe renal impairment with eGFR < 15 mL/min/1.73m*2 (calculated based on the MDRD equation) or on dialysis.
Is pregnant or breast feeding or plans to become pregnant or to breastfeed during the course of the trial.
Participated in another interventional clinical study and treatment with another investigational product ≤ 30 days prior to screening.
Secunderabad, Andhra Pradesh 500 003, India