Midodrine and Fludrocortisone for Vasovagal Syncope

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.

Conditions

• Syncope, Vasovagal

Interventions

DRUG

Midodrine Hydrochloride Tablets

Patients will be started on 5 mg Midodrine three times a day and after one week the dosage will be up-titrated to 10 mg three times a day and continued for 12 months. They will receive the medication at four-hour intervals upon rising in the morning (the last dose should not be taken later than 6 PM). In case of intolerance, the dosage will be reduced to 2.5 mg three times a day. Patients will also receive recommendations for lifestyle modifications including drinking 2 to 3 liters of fluid per day, daily consumption of 10 grams of salt, and practicing counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting).

DRUG

Fludrocortisone Acetate Tablets

Patients will be started on 0.05 mg of fludrocortisone twice daily and after one week the dosage will be up-titrated to 0.1 mg fludrocortisone twice daily taken for 12 months. Patients will also receive recommendations for lifestyle modifications including drinking 2 to 3 liters of fluid per day, daily consumption of 10 grams of salt, and practicing counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting). In this arm, potassium levels will be checked 7-14 days after dose stabilization.

BEHAVIORAL

Lifestyle modification

Patients will be recommended to drink 2 to 3 liters of fluid per day, consume 10 grams of salt per day, and practice counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting) for 12 months.

Sponsors & Collaborators

• Mahidol University

  collaborator OTHER

• Rajaie Cardiovascular Medical and Research Center

  collaborator OTHER

• Tehran Arrhythmia Center

  collaborator UNKNOWN

• Imam Khomeini Hospital

  collaborator OTHER

• AJA University of Medical Sciences

  collaborator OTHER

• Urmia University of Medical Sciences

  collaborator OTHER

• Isfahan University of Medical Sciences

  collaborator OTHER

• Shahid Beheshti University of Medical Sciences

  collaborator OTHER

• Ahvaz Jundishapur University of Medical Sciences

  collaborator OTHER

• Tehran Heart Center

  lead OTHER

Principal Investigators

• Arash Jalali, PhD · Tehran Heart Center, Tehran University of Medical Sciences

• Arya Aminorroaya, MD, MPH · Tehran Heart Center, Tehran University of Medical Sciences

• Hamed Tavolinejad, MD · Tehran Heart Center, Tehran University of Medical Sciences

• Saeed Sadeghian, MD · Tehran Heart Center, Tehran University of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-19

Primary Completion

2023-10-31

Completion

2023-12-31

Countries

• Iran

Study Locations