Midodrine and Fludrocortisone for Vasovagal Syncope

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Fludrocortisone; Midodrine

Criteria

Inclusion Criteria:

• Vasovagal syncope as the cause of transient loss of consciousness (Clinical diagnosis AND Calgary Syncope Symptom Score ≥ -2; Head-up tilt test is not mandatory for diagnosis)

• ≥2 episodes of syncope during the last year

• Medication-naïve or have at least a 2-week washout period prior to randomization

• The capability of giving informed consent

• Signed written informed consent

Exclusion Criteria:

• Other causes of transient loss of consciousness including orthostatic hypotension, postural tachycardia, carotid sinus hypersensitivity, or seizure

• Cardiac rhythm disorders including ventricular tachycardia, long QT syndrome, Brugada syndrome, arrhythmogenic right ventricular cardiomyopathy, complete heart block, and any conduction abnormality on electrocardiogram

• Severe valvular heart disease

• Hypertrophic cardiomyopathy

• Cardiac systolic dysfunction (ejection fraction≤40%)

• Obstructive coronary artery disease

• Hypertension

• Diabetes mellitus

• Cirrhosis

• Renal failure stage≥3

• Known intolerance or hypersensitivity to midodrine or fludrocortisone

• Urinary retention

• Pheochromocytoma

• Thyrotoxicosis

• Glaucoma

• Previous use of midodrine or fludrocortisone for treatment of VVS or another condition

• Pregnancy or breastfeeding