Table of contents
- Trial overview
- Study design and phase
- Who participated
- Treatments used in the study
- What the study measured
- What the results are meant to show
Trial overview
The trial data describe a Phase 2 study in people with heart failure.[1] The study was completed and enrolled 740 participants.[1]
The trial title is a proof-of-concept and dose-finding study of XXB750 in patients with heart failure.[1] Imidapril Hydrochloride appears in the list of study drugs used in the trial data.[1]
Study design and phase
This was an interventional study, which means the researchers gave a study treatment and then measured the results.[1] The phase was Phase 2, a stage that usually looks at whether a treatment seems to work in a specific patient group.[1]
The brief summary says the study looked at the efficacy, meaning how well the treatment worked, and the dose-response relationship, meaning whether different dose levels led to different effects.[1]
Who participated
The target population was symptomatic HF patients with LVEF < 50%.[1] Symptomatic means the patients had signs or symptoms of heart failure, and LVEF is a measure of how well the heart pumps blood.[1]
The summary also says participants were treated with standard of care, including ACEI/ARB or sacubitril/valsartan.[1] Standard of care means the usual treatment given for the condition.[1]
Treatments used in the study
The intervention list includes XXB750, placebo, and many active heart failure medicines such as Imidapril Hydrochloride, lisinopril, enalapril, ramipril, perindopril, captopril, benazepril, trandolapril, fosinopril, moexipril, quinapril, cilazapril, delapril, zofenopril, and several ARBs such as valsartan, losartan, candesartan, irbesartan, telmisartan, olmesartan medoxomil, and eprosartan.[1]
The trial data do not say that all of these drugs were tested in the same way for every participant; they are listed as study interventions in the trial record.[1]
What the study measured
The main endpoint was change in log NT-proBNP from baseline to Week 16.[1] NT-proBNP is a blood marker that can rise when the heart is under strain, and baseline means the starting point before treatment.[1]
Week 16 was the main follow-up time point in the trial.[1] The study used this measure to see whether treatment changed this heart-related marker over time.[1]
What the results are meant to show
This trial was designed to help researchers understand whether the study treatment could reduce NT-proBNP in people with heart failure.[1] It also aimed to learn which dose level may work best, which is why it is called a dose-finding study.[1]
Because the trial is completed, the record shows that the research plan was carried out in the enrolled patient group.[1] The trial data provided here do not include detailed outcome results beyond the planned primary endpoint.[1]
