Treatment Strategy of Vasovagal Syncope

• Status: Not yet recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, international multi-center, open-labeled, randomized trial.

The investigator speculated that CNA prevents more patients with moderate to severe VVS from syncope recurrence compared to midodrine.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Beijing Chao Yang Hospital; First Affiliated Hospital Xi'an Jiaotong University; First Affiliated Hospital, Sun Yat-Sen University; Fuwai Yunnan Cardiovascular Hospital; Henan Provincial People's Hospital; Ningbo No. 1 Hospital; RenJi Hospital; Yeditepe University Hospital
• Treatments: Midodrine

Criteria

Inclusion Criteria:

1. Age ≥ 18 years of age

2. Calgary Syncope Symptom Score ≥ -2 points

3. Positive response to head-up tilt test

4. With syncope episodes more than 3 times in the preceding year

5. Willingness to comply with follow-up requirements and to sign the informed consent

Exclusion Criteria:

1. Complied with other causes of syncope, including postural hypotension, aortic stenosis, sick sinus node syndrome, high-grade atrioventricular block, ventricular arrhythmias, pulmonary hypertension, hypertrophic cardiomyopathy, transient ischemic attack, epilepsy, sequelae of cerebral infarction or cerebral hemorrhage, subclavian vein steal syndrome and drug-induced syncope.

2. Complied with congenital heart disease, valvular heart disease, cardiomyopathy, and diabetes.

3. History of cardiac catheter ablation, peacemaker implantation and cardiac surgery.

4. History of midodrine usage, or compiled with contradiction of midodrine, including urine retention, hypertension (Bp≥140/90mmHg), glaucoma， renal dysfunction.

5. NYHA class IV congestive heart failure or LVEF < 35%

6. Pregnancy or breast-feeding

7. Life expectancy <1 year for any medical condition