Table of Contents
- Trial Overview
- Who Can Join
- What Is Being Measured
- Study Treatment and Study Design
- What the Results Mean
Trial Overview
The available study for TRIGLYCERIDES MEDIUM CHAIN is the REVIDAH study, which is described as an interventional trial in people with pulmonary arterial hypertension.[1] It is listed as Phase 3 and has a planned enrollment of 102 participants.[1]
The study status is Authorised, which means it has been approved to proceed in the source record.[1] The trial is designed to assess whether the study treatment helps patients improve without getting worse over time.[1]
Who Can Join
This trial is for patients with pulmonary arterial hypertension of specific types listed in the study record.[1] The included groups are idiopathic, hereditary, drug- and toxin-induced, and connective tissue disease-associated pulmonary arterial hypertension.[1]
- Idiopathic means the cause is not known.[1]
- Hereditary means the condition runs in families.[1]
- Drug- and toxin-induced means the condition is linked to a medicine or harmful substance.[1]
- Associated with connective tissue disease means it happens together with another disease that affects body tissues and blood vessels.[1]
What Is Being Measured
The main study goal is an efficacy outcome, which means the researchers want to see how well the treatment works.[1] The main endpoint is clinical improvement and no clinical worsening.[1]
In the study record, clinical improvement is defined by changes in at least two of these areas: walking distance, risk score, blood markers, and a heart function ratio.[1] Clinical worsening includes hospitalisation related to pulmonary arterial hypertension, therapeutic escalation, symptom progression, lung or cardiopulmonary transplantation, atrial septostomy, or death related to pulmonary arterial hypertension.[1]
- 6-minute walking distance (6MWD) checks how far a person can walk in 6 minutes and helps show exercise ability.[1]
- BNP and NT-proBNP are blood tests that can reflect strain on the heart.[1]
- TAPSE/SPAP ratio is a heart and lung blood flow measure used in the study to assess change.[1]
- Risk score changes are used to see whether the patient moves to a lower-risk category.[1]
Study Treatment and Study Design
The study record lists TRIGLYCERIDES MEDIUM CHAIN together with alpha-tocopherol and calcifediol as oral interventions.[1] The brief summary also mentions a vitamin D supplement strategy with calcifediol, compared with placebo, but the source record does not provide more detail about how the listed components are assigned to participants.[1]
Because this is an interventional study, researchers are actively testing a treatment plan rather than only observing patients.[1] The key time point in the brief summary is week 24, when the main comparison is made.[1]
What the Results Mean
If the study shows more clinical improvement and less clinical worsening, that would suggest the treatment approach may help people with pulmonary arterial hypertension.[1] If the results do not show a clear difference, the study may still help researchers understand which outcome measures are most useful in this disease.[1]
For patients, the important part of this trial is that it focuses on real-life changes such as exercise ability, blood tests, heart strain, symptoms, hospitalisation, and survival-related events.[1] These are the kinds of outcomes that matter when studying treatment benefit in pulmonary arterial hypertension.[1]
