Table of Contents
- Trial overview
- Heart failure sex-gap study
- Heart failure remission study
- Endpoints and measures
- Who the trials are for
- What Phase 3 means
Trial overview
Two authorised interventional studies are investigating Lisinopril as part of heart failure research.[1][2] Both studies are in Phase 3, which means they are later-stage trials with patient outcomes as the main focus.[1][2]
The first study looks at how guideline-directed medical therapy, or GDMT (the recommended treatment plan for heart failure), is used and whether there are sex-related differences in care.[1] The second study looks at whether partial withdrawal of heart failure therapy is safe and feasible in patients whose heart failure is in remission.[2]
Heart failure sex-gap study
The study titled “Pharmacological optimization in prevention in Heart Failure: A Sex-gap?” is a Phase 3 interventional trial with 368 planned participants and an authorised status.[1] It focuses on people with heart failure and uses registry data to describe the current pattern of GDMT use across the country.[1]
This study also examines inequality related to sex, meaning it wants to see whether women and men receive similar heart failure treatment in real life.[1] The brief summary says the prospective part is a pragmatic multicentre trial, which means it is designed to fit routine care in several hospitals and to study results in a practical setting.[1]
The treatment list in this trial includes many heart failure medicines, and Lisinopril is one of them.[1] Other listed medicines include several other blood pressure and heart failure drugs, but the trial focus is not the drug alone; it is the wider treatment strategy and outcomes in heart failure care.[1]
Heart failure remission study
The second study is titled “A trial investigating partial withdrawal of heart failure therapy in patients with heart failure in remission.”[2] It is also authorised, Phase 3, and planned for 100 participants.[2]
This trial studies whether reducing heart failure therapy, instead of continuing it, is safe and workable in patients whose heart failure is in remission.[2] In this study, Lisinopril appears in the treatment list together with other heart failure medicines such as Jardiance, bisoprolol, and spironolactone.[2]
The main idea is not to test Lisinopril alone, but to understand what happens when heart failure treatment is partly withdrawn compared with continuing treatment.[2]
Endpoints and measures
An endpoint is the main result a trial measures to see whether the strategy works.[1][2] In the first study, the retrospective part measures the current status of GDMT prescription and sex-related inequality using national registry data and a database called Mecki.[1]
The prospective part of the first study measures all-cause mortality within 1 year, heart failure readmission, and worsening heart failure.[1] It also looks at quality of life, adherence to drugs, meaning whether patients stay on treatment as planned, and side effects.[1]
In the second study, the primary outcomes are left ventricular remodeling, NT-proBNP increase to more than 500 pg/mL, and all-cause mortality.[2] Left ventricular remodeling means changes in the heart’s main pumping chamber, and the study measures this in a core echocardiography laboratory.[2]
The remodeling endpoint is defined as an increase in left ventricular end-systolic volume index of more than 20% from baseline, which is the first measurement taken before treatment changes.[2] NT-proBNP is a blood marker that can rise when heart failure becomes worse.[2]
Who the trials are for
These studies are for adults with heart failure or heart failure in remission.[1][2] The first study specifically aims to understand treatment gaps in women with heart failure during follow-up, so women are an important target group in that trial.[1]
The second study includes patients whose heart failure is in remission, meaning their condition is currently controlled enough for the research team to study partial withdrawal of therapy.[2] Both trials are meant to reflect real clinical care and to answer practical questions about treatment strategy rather than to test Lisinopril as a single stand-alone treatment.[1][2]
What Phase 3 means
Phase 3 trials usually study a treatment in larger groups of people to learn how well it works and how safe it is in the target population.[1][2] In these two studies, Phase 3 supports the idea that the researchers are looking for meaningful patient outcomes such as survival, hospital use, heart function, and quality of life.[1][2]
Because both studies are interventional, the researchers are not only observing patients; they are also testing different treatment approaches and comparing outcomes over time.[1][2]
