Midodrine and Fludrocortisone for Vasovagal Syncope
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
Syncope is a common condition which can disturb daily functions of the patients and impair
their quality of lives. It contributes to 0.8 to 2.4% of the visits of emergency rooms.
Noticeably, studies demonstrated that the lifetime prevalence of syncope is as high as 41%
with a 13.5% recurrence rate.
The cornerstone of the treatment of vasovagal syncope (VVS), the most common type of syncope,
is lifestyle modifications and patient education to avoid potential triggers of syncope.
These recommendations alleviate vasovagal spells in many patients; however, some patients
experience life-disturbing vasovagal attacks despite compliance with these modifications.
This fact underscores the importance of efficient pharmacological interventions as well.
Currently, there is an ongoing controversy about the efficacy of midodrine and
fludrocortisone as adjunct pharmacological interventions for the prevention of VVS. In the
COMFORTS trial, we are going to evaluate the efficacy of midodrine, fludrocortisone, and
lifestyle modifications for prevention of vasovagal attacks in patients with VVS.
Phase:
Phase 3
Details
Lead Sponsor:
Tehran Heart Center
Collaborators:
Ahvaz Jundishapur University of Medical Sciences AJA University of Medical Sciences Imam Khomeini Hospital Isfahan University of Medical Sciences Mahidol University Rajaie Cardiovascular Medical and Research Center Shahid Beheshti University of Medical Sciences Tehran Arrhythmia Center Urmia University of Medical Sciences