In short
Clinical trials are investigating Meldonium in people with chronic heart failure, especially heart failure with preserved ejection fraction. These studies aim to see whether Meldonium, together with individualized physical activity advice, can improve exercise tolerance and other patient outcomes.
Key points
- Meldonium is being studied in a Phase 3 trial for people with chronic heart failure with preserved ejection fraction. The study is looking at Meldonium together with individualized physical activity recommendations. The main goal is to see whether this approach improves physical activity tolerance. Researchers are measuring this with a cardiopulmonary test, including VO2 max. The trial is authorised and plans to enroll 200 participants.
Trial overview
This clinical trial is studying Meldonium in patients with chronic heart failure with preserved ejection fraction.
The study is authorised and is designed as an interventional trial, which means the researchers are giving a treatment and then checking the results.
Who is being studied
The target population is people with chronic heart failure with preserved ejection fraction, a form of heart failure where the heart still pumps out a normal-looking amount of blood but does not work properly.
The trial data do not list more detailed participation rules, so the main known group is patients with this heart condition.
What the trial tests
The study is testing Meldonium and individualized physical activity recommendations together in the treatment of these patients.
The brief study summary says the goal is to evaluate effectiveness, which means the researchers want to find out whether this approach helps patients in a real way.
Trial phase and size
This is a Phase 3 study.
Phase 3 studies usually involve more people than early-phase studies and are used to test how well a treatment works in a larger group.
The planned enrollment is 200 participants.
Outcomes being measured
The main outcome is physical activity tolerance, which means how well a person can manage exercise or movement without too much strain.
This is measured by a cardiopulmonary test, including relative maximal oxygen uptake, also called VO2 max.
VO2 max is a way to measure how much oxygen the body can use during exercise, so it helps show exercise capacity.