Table of contents
- Clinical trials overview
- Study design and phase
- Who can participate
- What the trial measures
- Trial status and size
Clinical trials overview
The available trial is an interventional study, which means researchers give a treatment and then measure what happens.[1] It is studying HYDROGEN for people with atrial fibrillation after ablation, with the goal of checking whether it can reduce early return of abnormal heart rhythm and improve quality of life.[1]
The trial brief summary says it is designed to study the efficacy of inhaled HYDROGEN therapy on early recurrence after ablation and quality of life at 3 months.[1]
Study design and phase
This study is in Phase 2.[1] Phase 2 trials usually look more closely at whether a treatment seems to work in the target group, while continuing to observe safety information as part of the study process.
The intervention listed is a gas mixture of HYDROGEN and nitrogen, given by intranasal use, which means through the nose.[1] The source data do not provide more details about the treatment schedule.
Who can participate
The trial targets people with atrial fibrillation who have had ablation.[1] The source data do not list age limits, sex limits, or other detailed entry rules.
Because the study focuses on early recurrence after ablation, it is aimed at patients in the period soon after this heart procedure.[1]
What the trial measures
The main endpoint is a composite endpoint, which means it combines two results into one main study goal.[1] First, the study checks for the absence of early recurrence during the blanking period, which is the first 3 months after ablation.[1]
Early recurrence is defined in the trial as any episode of atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 30 seconds.[1] Second, the study measures improvement in quality of life using the AFEQT score, and improvement is defined as a drop of at least 5 points from day 0 to month 3.[1]
This means the study is not only looking at heart rhythm, but also at how people feel and function in daily life.[1]
Trial status and size
The trial status is Authorised.[1] The planned enrollment is 136 participants.[1]
Based on the source data, this is the only identified clinical trial for HYDROGEN in this dataset, and it focuses on atrial fibrillation after ablation.[1]
