UnknownNot Applicable

Treatment Strategy of Vasovagal Syncope

China184 participantsStarted 2023-04-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years of age
✓. Calgary Syncope Symptom Score ≥ -2 points
✓. Positive response to head-up tilt test
✓. With syncope episodes more than 3 times in the preceding year
✓. A proven failure of non-pharmacologic treatment, including reassurance regarding the benign prognosis, education about the avoidance of situations and triggers initiating syncope， application of PCM during the occurrence of prodromal symptoms, and lifestyle modifications（adequate fluid intake and salt supplementation）， according to the guideline
✓. Willingness to comply with follow-up requirements and to sign the informed consent

Exclusion criteria

✕. 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.
✕. Complied with congenital heart disease, valvular heart disease, cardiomyopathy, and diabetes.
✕. History of cardiac catheter ablation, peacemaker implantation and cardiac surgery.
✕. History of midodrine usage, or compiled with contradiction of midodrine, including urine retention, hypertension (Bp≥140/90mmHg), glaucoma， renal dysfunction.
✕. Life expectancy \<1 year for any medical condition
✕. Pregnancy or breast-feeding

What they're measuring

Number of Participants with syncope recurrence during follow-up

Timeframe: 12 month after randomization

Trial details

NCT IDNCT05803148

SponsorChina National Center for Cardiovascular Diseases

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-12-30

Contact for this trial

yan Yao, PhD

13901121319 ianyao@263.net.cn

View on ClinicalTrials.gov More Syncope, Vasovagal trials