Table of Contents
- Trial overview
- Who is being studied
- What the trial tests
- Trial phase and size
- Outcomes being measured
Trial overview
This clinical trial is studying Meldonium in patients with chronic heart failure with preserved ejection fraction.[1]
The study is authorised and is designed as an interventional trial, which means the researchers are giving a treatment and then checking the results.[1]
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.[1]
The trial data do not list more detailed participation rules, so the main known group is patients with this heart condition.[1]
What the trial tests
The study is testing Meldonium and individualized physical activity recommendations together in the treatment of these patients.[1]
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.[1]
Trial phase and size
This is a Phase 3 study.[1]
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.[1]
The planned enrollment is 200 participants.[1]
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.[1]
This is measured by a cardiopulmonary test, including relative maximal oxygen uptake, also called VO2 max.[1]
VO2 max is a way to measure how much oxygen the body can use during exercise, so it helps show exercise capacity.[1]
